Update: August 13, 2024
Pelage Pharmaceuticals (US) just announced that the first patients have been dosed in its Phase 2a clinical trial evaluating the safety and efficacy of PP405. This drug is a novel topical small molecule for the treatment of androgenetic alopecia. The company is enrolling 60 men and women in the clinical study. PP405 addresses the metabolic processes that regulate activation of hair follicle stem cells.
Also of significance, Pelage raised $14 million in Series A-1 financing that was led by Google Ventures (GV). This follows an initial $16.75 million Series A financing round in February 2024 (see bottom of this post). The Series A-1 is a result of positive Phase 1 data that demonstrated proof of mechanism and target engagement in patients with AGA.
Phase 2 Trials for PP405 Begin
Update: July 20, 2024
We now have more details on the Phase 2 trials for PP405. Including a short survey to determine eligibility. All 6 US states that I mentioned in the last update are now recruiting volunteers (with Texas having two locations). You have to be between the ages of 18-55, and once-a-week visits will be required for 16 weeks. The product comes in the form of a topical gel. Pelage Pharmaceuticals also has an update with the above link on its home page.
Update: June 12, 2024
Pelage Pharmaceuticals’ Phase 2 clinical trials of PP405 officially started on June 5, 2024. They are currently recruiting volunteers in Indiana, Minnesota, Texas and Utah. Still to come are California and Virginia. The primary completion date is December 2024, and the study completion date is February 2025. PP405 is an inhibitor of mitochondrial pyruvate carrier (MPC).
Pelage Pharmaceuticals
I previously wrote about Pelage Pharmaceuticals in my 2019 post related to the research of its President and co-founder Dr. William Lowry. The other co-founders are Dr. Heather Christofk and Michael Jung. I also covered the findings of Dr. Lowry and Dr. Christofk’s UCLA team in a 2017 post.
These UCLA researchers discovered two topical compounds (RCGD423) and (UK5099) that regrew hair in mice via different mechanisms. Both drugs involve an increase in lactate production. This in turn activates hair follicle stem cells and leads to increased and quicker hair growth.
Dr. Lowry’s patent can be found here. Patent and technology rights to both topical drugs have been exclusively licensed to Pelage Pharmaceuticals by UCLA.
RCGD423
RCGD423 activates the JAK-STAT signaling pathway, which in turn leads to an increase in lactate production. This extra lactate activates hair follicle stem cells and results in quicker hair growth. The main 2017 study on RCGD423, lactate dehydrogenase activity and hair follicle stem cell activation can be read here. I also covered it in my earlier linked posts related to the work of Pelage co-founders Dr. William Lowry and Dr. Heather Christofk.
UK5099
UK5099, blocks pyruvate (a glucose metabolite) from entering cell mitochondria. This also results in an increase in lactate production in the hair follicle stem cells, and therefore accelerates hair growth. There is a 2015 study from China related to the application of mitochondrial pyruvate carrier blocker UK5099 and its effects on prostate cancer cells.
Update: May 6, 2024
Pelage Pharmaceuticals Phase 2 Clinical Trials Start in June 2024
Yesterday, a reader e-mailed a new link on Pelage Pharmaceuticals’ Phase 2 clinical trials for its PP405 inhibitor of mitochondrial pyruvate carrier (MPC). The Phase 2 trials are set to begin in June 2024 and will involve 60 participants. Half of these will take a PP405 0.05% topical gel once per day, and the other half will get a placebo vehicle daily gel. The study primary completion date is December 2024, and actual completion date is February 2025.
Recruitment will likely start soon, and I assume it will be in the US based on the listed contact person and phone number. The contact e-mail is listed as clinicaltrials@pelagepharma.com. Please DO NOT call them now as the recruitment has not yet commenced and they might get annoyed.
If you are between the ages of 18-55 and have androgenetic alopecia, you can participate. However, the inclusion criteria for men and women is specific:
- Males must have an AGA modified Norwood-Hamilton Classification score of Type III vertex, Type IV or Type V.
- Females must have a Savin classification score of I-2, I-3 or I-4.
Update: March 9, 2024
Positive Phase 1 Clinical Trial Results
Earlier today, Pelage Pharmaceuticals gave a positive update on its novel small molecule PP405. Full summary can be read here. In Phase 1 clinical trials, PP405 reactivated dormant hair follicle stem cells and triggered hair growth. The company’s presentation was made by Dr. Christina Weng and titled: “Inhibition of pyruvate oxidation activates human hair follicle stem cells ex vivo”. Pelage will begin its multi-center Phase 2a trial of PP405 in mid-2024. It will recruit both men and women with androgenetic alopecia.
Their description of this unique hair growth molecule is as follows:
“PP405 is a potent topical mitochondrial pyruvate carrier (MPC) inhibitor that acts on the cellular metabolic pathway to upregulate lactate dehydrogenase (LDH).”
Stem cells are particularly sensitive to LDH, so this results in their activation and subsequent hair growth. PP405 demonstrates a statistically significant increase in Ki67 signaling in the hair follicle bulge. Ki67 is a well-established marker of stem cell proliferation.
February 27, 2024
Pelage Pharmaceuticals Raises $16.75 Million and Phase 2 Trials to Begin in 2024
Pelage Pharmaceuticals has raised $16.75 million in Series A Financing. More importantly, they will begin Phase 2 Clinical Trials for PP405 in mid-2024.
Phase I clinical data met primary safety endpoints. And they confirm that their was statistically significant stem cell activation in hair follicles after just one week of treatment with PP405.
Per CEO Daniel Gil, Ph.D.:
“Our scientific co-founders have uncovered a unique biological mechanism with the potential to reactivate hair growth in people with alopecia.”
The company will present translational data at the American Academy of Dermatology meeting in March 2024.
Recently, reader “Ben” made an very interesting discovery on Pelage Pharmaceuticals’ website. The following sentence at the bottom:
“Early Phase I clinical data shows statistically significant stem cell activation in the hair follicles after one week of treatment with PP405.”
This is super news. So their trials have started. I wonder if PP405 is RCGD423 or UK5099? I think it sounds like that latter. The company’s website homepage describes PP405 as:
“A novel, non-invasive, topical small molecule drug platform that activates stem cells in the hair follicles directly to stimulate robust hair growth. By targeting an intrinsic metabolic switch in hair follicles, Pelage’s platform is suitable for all genders, skin types, and hair types.”
In other recent news, Pelage appointed Dr. Qing Yu Christina Weng as Chief Medical Officer.
I wonder if this is going to be an every day for the rest of your life therapy or maybe front load with an every day application, then taper off to once a week.
I wonder if the rest of my life I’ll watch new drugs and chemicals come to us with a promise of hope that never delivers. Probably.
The new alopecia areata and weight loss drugs seem to have delivered :-)
This is why I’ve been saying that Dr Rassman was wrong when he said that the follicles after a while disappear. He must not be directly involved in the clinical trials of Amplifica. As Pelage has proven that the follicles ARE there, they’re just dormant. The next few years may be very transformative for the treatment of hair loss.
In alopecia areata patients who are completely bald, hair is regrown. So dr Tasman is completely wrong in here.
i thought we would have heard from Amplifica by now! Where is the robust hair growth on humans?
I have been thinking the same thing! Maksim was big news at one time. Like all the others they just vanish!
Relax they’re collecting their data and presenting it to the FDA it takes time it doesn’t happen when we want it to.
How hard is it to ” collect data?” I’m so sick of this “industry.”
Yoyo friend, I believe that inactive follicles end up disappearing over time. Imagine a completely bald person who has lived like this for most of his life, the stem cells from the inactive follicles will have escaped through the pores of the dermal papilla and become skin cells. That is why I believe that this and the other medications will be very useful and effective in people with lesser degrees of alopecia or who are beginning to experience it. That’s why I think the only way to give an NW7’s hair back is hair cloning…
If you have a look under “How our drug works” they state that the hair follicle is present but in a ‘resting state’. https://pelagepharma.com/
Right, so it’s not going to bring back lost hair. Or is it? Is the follicle dormant or dead once you’re bald? It’s wild we can’t (for sure) answer this question by now. You’d think we’d have a definitive answer but I’ve seen people (even experts) argue both ways.
If it’s gone, what kind of hair growth do they mean? Maybe baby hairs to thicker hairs? Maybe single hair follicles to multiple? Quite a few questions.
I’ve always been skeptical of a topical really curing anything (depending on your definition) but it sounds promising. Trial will tell us for sure. I’m to the point now where it’s photos (after the trial) or I write them off. My feeling is that lack of photos means “you got nothing.”
Niostem is supposed to work on a similar basis, and the pictures on their website appear promising (the results of their larger efficacy trial are due next quarter).
These are marketing photos on their website and the lighting is different in the before and after. At least it seems that way to me. I’ll be curious to read the results from the trial you mentioned. I hope the photos are more authentic.
Interesting…..not that it means anything is coming to market in the next few years but I really like the number of treatments on the horizon with new methods of action. There is HMI-115, TDM-105795, Amplifica, Pelage, Stemson. In the big pciture of things, I think this is emblematic of the evolution of the overall research and that real progress is being made. While PP405 is great news, I don’t see a clinical trial for this on clinical trials.gov using any possible search word related to Pelage. For that matter, I don’t see one for Amplifica either and their study was supposed to have started June 28, 2023. Given that PP405 has shown “statistically significant stem cell activation in the hair follicles after one week of treatment”, I am not sure how they would know that if the data was on human test subjects although I suppose they could take a very small biopsy. If PP405 does activate stem cells in humans within 7 days, they probably won’t need more than 2-3 months to show efficacy…….although since this molecule turns on pathways I would guess confirming safety would take a lot longer.
Pelage is not very active on giving updates on what they are doing or promoting their company much it seems, hopfully they dont need to, becouse they know that they have a good product. A lot of good news seem to be coming in lately, one of these will probably hit the target in the coming ten years, looking forward to who that might be!
Why did Pelage remove their news section lol, just keep it simple.
Phase 2 set for mid 2024 :) https://www.finsmes.com/2024/02/pelage-pharmaceuticals-raises-16-75m-in-series-a-funding.html
Thanks!
No problem admin, with them receiving $16.75M (slightly more than Stemson) do you think Pelage’s investors have confidence in believing that this treatment will (hopefully) become a huge success? They may have seen the successful effects of PP405 first hand?
Since Pelage can bring this to market much faster than Stemson, that might be the main attraction.
Insofar as actual hair regrowth goes, Stemson represents a cure! So it is much more significant than Pelage (if it ever comes to market of course).
For sure, but with a hair transplant and yearly top ups of Pelage’s solution that could provide some serious coverage for the time being until a more permanent treatment (such as Stemson) could fix the issue of hair loss indefinitely? Thanks again.
Sorry Admin I have one more question do you think this will be like Minoxidil in the sense that daily application will be required or do you think it will be like Amplifica where you have to apply the product 2/3 times a year? “Provided confirmation of a daily dosing regimen”
Not sure YoYo, but maybe the past study or patent mentioned in the below article will have something about dosage:
https://newsroom.ucla.edu/releases/ucla-scientists-identify-a-new-way-to-activate-stem-cells-to-make-hair-grow
Given that Pelage apparently completed Phase 1 without us knowing about it until very recently, and further given that they are planning phase 2 for the 2nd half of 2024, this company is moving at a far greater speed than we realized. I had been wondering what was taking them so long to get started (and thinking this was a red flag indicating possible early signs of a flop), but this company has been flying under our radar. This gives me confidence that they have the ability to race toward approval if phase 2 produces evidence of effectiveness. I do like the fact that, to date, they have spent little time publicly promoting themselves. And I also like their quote that pp405 has : “….the potential to disrupt the treatment landscape, moving beyond agents that merely slow the progression of hair loss to a treatment solution that actually helps to regrow hair”
Here are a few more quotes from Pelage:
“The phase 1 study was also designed to determine a dosing regimen for PP405. We compared 1x/day topical dosing with 2x/day topical dosing and discovered the same biological and safety response to both. Moving forward into phase 2a, we will proceed with 1x/day dosing.
“Our phase 1 study shows no detectable levels of drug in the blood, while simultaneously achieving the levels of PP405 in the scalp skin associated with hair growth from translational studies.”
They have kind of a secretive behavior towards the public, that’s clear. The funding was already being done last June and the first trial was never officially announced, it must have been initiated after their last big paper (https://onlinelibrary.wiley.com/doi/10.1111/exd.14307), probably in 2022?
Anyhow it’s absolutely great news that they are already starting phase 2 and have new staff plus sufficient funding. I always had a soft spot for Pelage, but we were kept in the dark. It’s also quite remarkable that some really big names in medical research are also involved in hair loss R&D (Terskikh,Bharti/Stemson, Christofk, Lowry/Pelage, Plikus/Amplifica) – all of them pursue more important topics like oncology too.
Contrary to your opinion admin I think this could possibly be very close to a cure, if they effectively awake HFSCs then this could cause some immense regrowth of hair. The published pictures speak for themselves.
#Stemson: I always said they are even more than a cure as it could supply people with more hair they ever had…but that’s semantics.
In the past I read that bald scalps still have all the hair, but the progenitor cells are gone as are the arrector pili muscles.
Hope those last two do not matter as much as we think. Or can be regenerated.
In mice, they do not matter for sure!
But Admin I understand what you’re saying about having certain doubts however Pelage have stated that their product results in massive hair regrowth so who’s to say it won’t be the closest thing to a cure? (obviously Stemson would supersede)
Yeah, perhaps I have become too biased towards Tsuji and Terskikh due to having read about their research for almost a decade. Too many others have come and gone.
Of course I could be wrong too only time will time (hopefully I’m right though lol)
It’s simple, the hair shafts grow from the hair follicle, which we have all seen in images of hair transplants… It is something visible, like a little ball from which the hair sprouts. If it is there, in a hair transplant operation, before transplanting the hair follicles from the donor area, you would first have to remove the inactive hair follicles from the bald area to make room for the others, right?
Not sure if their funder being GV adds any weight, but they look like a pretty serious VC.
Someone e-mailed me for the full paper link if available.
Below Sci-Hub version is working at present:
https://sci-hub.ru/https://onlinelibrary.wiley.com/doi/10.1111/exd.14307
Also, on a slightly related note, for Paywalled articles, the below works well for me these days:
https://archive.ph/
Archive.org stopped archiving most paywalled articles from well known sites.
You may remember this admin……..when the research underlying Pelage first came out from U Cal, I was excited about it, but it was also about the same time that Frequency Therapeutics had shown they could regrow ear hair. I was more excited about Frequency. Well, they have since folded but Pelage is on the move.
Yes, I remember well Pinotq.
https://www.hairlosscure2020.com/researchers-regenerate-ear-hair-cells-via-increasing-progenitor-cells-wnt-pathway-stimulation-also-involved/
I was too! I owned stock in Frequency!
https://medcitynews.com/2024/02/hair-loss-drug-regenerative-medicine-ucla-startup-pelage-gv/ More information for those interested. It looks like this is something that you have to apply daily :(. I’m starting to like Amplifica more now since you won’t be having to apply that everyday
Let’s be honest, if something truly seriously actually abundantly works, we’d apply it 5 times daily.
Love this quote: “Unlike pricey and lengthy cancer and gene therapy clinical trials, a hair loss clinical trial is quick to enroll and conduct, and therefore considerably less expensive.” I had always thought a hair loss clinical trial should be quicker and easier to assess but, until now, that does not appear to have been the case.
I also love this quote as it relates to safety, and therefore also possibly speed to market: ““It’s a very clear pathway, which is well understood from many years of study in the lab.”
Where do you always find those great articles YoYo…thanks for that.
I don’t care if I have to apply daily, I brush my teeth daily, wash my remaining hair daily, eat daily. It’s all routines. It has to be uncomplicated and easy to apply though, and not greasy or slimy. Quickly absorbed and I‘m happy, as long as it is effective.
I cannot help but laugh again:
„The following year, it reached an agreement that granted Allergan an option to acquire the startup. The agreement provided Pelage with non-dilutive financial support, Gil said. Allergan itself was acquired by AbbVie in 2020. After that deal closed, Pelage and AbbVie agreed to terminate the option“
So we probably lost 3 years again, just like with OrganTech. I don’t understand why those behemoths are so tight with those comparatively tiny amounts? The reward of a hair-loss-cure is huge! Also explains why they have been so quiet over the years, they were basically inactive…
Also worth noting:
„Unlike pricey and lengthy cancer and gene therapy clinical trials, a hair loss clinical trial is quick to enroll and conduct, and therefore considerably less expensive“
Makes it even less understandable. Well at least they have a proper CEO and business-strategy now. Let’s awaken those HFSCells now!
Thank you Ben, I have my resources lol. I wouldn’t mind putting the solution on everyday either it’s just having that much solution applied topically daily who knows what the accumulative systemic side effects will be over the years until a true cure will be found (ie stemson or Fukuda). That’s my only worry. With Amplifica it’s more of a one and done deal (until the next appointment)
Interestingly though, Pelage’s current CEO is a former Allergan executive, and in this piece (https://magnify.cnsi.ucla.edu/2024/02/27/february-27-2024-gv-backs-hair-loss-biotech-out-of-ucla-with-phii-set-for-mid-2024/) is quoted as saying “We had always been surveying the hair growth landscape quite a bit, and this was a technology that we really liked at that time,”. Also a positive quote from GV executive in that piece. All told, it looks like Pelage and Amplifica are the two California startups that will be the first to crack this problem.
Another good article providing a few more clues. I note that some posters didn’t like what they thought was the requirement of an every day application of PP405 but according to Cathy Friedman, the board member at GV venture partners, the trial “endpoints will be at three to six months and treatment will last four weeks.” Personally, I could care less if I had to apply daily for the rest of my life if it worked, but ultimately, this may be a treatment that you only need to apply once a quarter, once a year, as needed, etc.
I think that has the be found out in the next trial, dosing frequency.
But you might be on the right track: if they dose daily for 4 weeks and then measure after 3/6 months, they must have some preliminary data that this treatment lasts for a certain time without dosing.
A big question for me is, if you have more „bald surface“, how much more amount of topical would you need? And do you alse treat the area that is potentially gone in the future but has hair now?
Anyhow, big hopes for Pelage. They are on the verge of breaking into my personal Top 3: Amplifica, HopeMed, Fukuda – with Fukuda being the shaky candidate due to the recent uncertainty.
I was wondering about coverage myself. I don’t know how much a doctor could prescribe but if twice per day dosing was as safe and effective as once per day, I would think you could safely use the equivalent of 2 doses per day, covering different areas. Maybe not 2 doses at the same time but possiby covering a one area in the morning and another at night. I would want to treat as much of an area as I could to increase the density. Even where I have a decent amount of hair, its not what it used to be. My big question is what amount of statistical significance they found with only 7 days of treatment and how much that significance will increase with 4 weeks of application. Much to learn and I find it fascinating. I am guessing they might be planning to test for more than 1 variable, depnding on what they find, since the next test is a Phase 2a.
“What we’ve observed is that in people who experience hair loss, the actual hair follicle stem cells are still present but have reverted to a dormant state. We have uncovered a small molecule able to stimulate cellular metabolism to re-awaken hair follicle stem cells and spur new hair growth,” said William Lowry, PhD, Pelage’s scientific co-founder, in the news release.
https://www.dermatologytimes.com/view/new-topical-agent-for-alopecia-to-enter-phase-2-trials
In the niostem webinar today the presenter seemed to say as people live longer with hair loss the stem cells miniaturize past a point of no return :(
Years ago, I wrote about widely discussed findings related to how hair cells and follicles are always there, even in totally bald scalps. But progenitor cells get depleted. Later, we were told that arrector pili muscles also get depleted.
In any event, there have been way too many cases where long-time Norwood 5-6 bald people regrow a lot of hair. Including from things like burns, wounds, oral minoxidil and dutasteride. Plus future cloning, multiplication etc.
https://www.hairlosscure2020.com/so-it-seems-like-totally-balding-areas-of-the-scalp-can-regenerate-long-lost-hair/
https://www.hairlosscure2020.com/male-to-female-mtf-transition-hair-growth/
https://www.hairlosscure2020.com/reddit-oral-minoxidil-hair-growth-reviews/
Thanks for the white pill :)
Hey admin – is there a chance that you can change your settings on „recent comments“ to 5 or 7?
Would make it easier to follow the forum.
Good idea and done.
In the past, I got several errors/speed improvement suggestions in my page load speed tests if there were too many “recent comments” (plus the now removed “recent posts” and “category” menus).
That was quick – thanks!
Hello everyone!
Just a question for clarification. Since only males up to NW 5 are sought in phase 2, people with NW 6 and 7 will have to wait for the cloning of hair follicles. Thank you!
I’ve been saying that! lol
https://www.linkedin.com/posts/daniel-gil-165067aa_pelage-pharma-press-release-activity-7173133159922872320-N4Ei/?utm_source=share&utm_medium=member_desktop The chief executive officer on American Academy of Dermatology meeting
Thanks YoYo!
I’m here to serve you admin. Lmao I’m joking, no worries you put in so much work we should return the favour from time to time.
Dr. William Lowry presenting at WCHR2024 on April 9, 2024:
Topical Inhibition of the Electron Transport Chain Stimulates
the Hair Cycle
William Lowry, PhD | USA | University of California, Los Angeles
Pelage went from being skeptical to being one of my top 3 most intriguing companies.
Where is this Admin? I cant see it on the program for WCHR2024
https://hair2024.org/wp-content/uploads/2024/03/wchr24-final-program-guide-single.pdf page 45
Admin do you think that Pelage will release some form of pictures after the completion of Phase II? Or not until they finish all 3 phases?
They will release the data for sure. If growth is say 5 hairs per cm square, I am not sure if pictures will show much.
I now wonder if pictures are required to be released after Phase 2 trials.
I see, because this has the potential to cause massive hair growth which is why I thought they would like to release some photos to attract the general public as well as more investors.
If the results are excellent, I do not see why they would not want to release photos.
Hello everyone
Is there any news about Pelage? I hope you have a nice Sunday :-)
Initiating phase ll trials starting midway of this year.
Should we keep any hope on this?
Nah don’t.
“PP405 is a potent topical mitochondrial pyruvate carrier (MPC) inhibitor that acts on the cellular metabolic pathway to upregulate lactate dehydrogenase (LDH).”
I can tell you this as someone that has studied biochemistry extensively; pyruvate inhibition in the mitochondria is serious business. It is basically how all energy in the body is made. This might have heavy side effects.
Well that’s what trials are for, aren’t they?
I think it is great news that they said they could and would move quickly to begin a phase 2 trial, and they are doing just that! So now we know that gearing up for a trial doesn’t have to be an endlessly painful endeavor. They appear confident and motivated which makes me wonder what they have continued to see from the phase 1 trial. In their press release they said they could see evidence of newly emerging hair germs so they must have some idea by now of the quality of the hairs that have sprouted from the scalp.
Up to norwood 5 which is quite advanced stage. Would be good to see this treatment work well on advanced AGA. Fingers crossed when they release the phase 2 results next year it is good news!
Wow! revitalizing the hair follicle stem cells could be a game changer….i hope this works!
Will this help for DUPA guys?
Pelage says it “will begin its multi-center Phase 2a trial of PP405 in mid-2024, recruiting both men and women with androgenetic alopecia. PP405 may also have applications for other forms of alopecia, including telogen effluvium (stress-induced hair loss) and chemotherapy-induced hair loss.” DUPA is a form of androgenic alopecia so I don’t know why it would not work……..of course that assumes the trials will ultimately prove successful.
For sure… dupa is miniturization of the hair follicle on the sides and back of your head which is caused by typical androgenic alopecia. There is no reason to suspect it wouldn’t treat Dupa.
I am seeing nowdays the trend of GFC instead of PRP and people are saying the result is better than PRP. Admin Can you also cover this so we get to know more about that.
Trials started!
Thanks!
Actual Study Start Date = June 5, 2024.
Estimated Primary Completion Date = December 2024.
Estimated Study Completion Date = February 2025.
Thanks Admin for the update! I couldn’t find this online, was this something that was personally emailed to you? Thanks
It is in here:
https://classic.clinicaltrials.gov/ct2/show/NCT06393452
Would be great if you were able to get an interview with Pelage, Admin!
It varies on a monthly basis lol, but at the moment Pelage is my favorite.
The concept to jumpstart dormant HfScs seems to be the best way to have massive regrowth.
Well researched, well funded, well managed. I hope for all of us that this is the breakthrough we desperately need.
100% agree with you Ben, not only is the MOA understood but like you said, they are well funded and well research. This could definitely be a game changer alongside the fact that they are trucking along at a very good pace. We will have to wait until next year to see the results but by that time we should be updated by Amplifica and Stemson.
I mentioned it in the Stemson-thread, there’s something curious at Stemson.
They let go approximately 10 people since the Aderans-announcement. Their R&D-team is now down to 12 and all vacancies are erased from the website.
I don’t know what that means – could be nothing. Maybe they finished R&D and don’t need the people anymore, and clinical development is handed over to a CRO. Or they have financial difficulties…
What’s your take YoYo?
Oh wow Ben, so it seems like I wasn’t the only one who noticed that lol. Yea I’ve been eyeing it for some time and I too am conflicted on what that exactly means. Respectfully I have to disagree on the funding part, as they are heavily backed up by powerful investors and based off the results Stemson has been providing to their investors they seem to be confident in where their money is going so far. I could be 100% wrong, but based off the timelines that Geoff was giving, he was talking about basically refining the process at this point and gearing towards clinical trials as they are initiating to do so towards the end of next year. So it may be the case that they don’t require as many people, as when they needed while in the beginning/middle stages of Stemsons development, as that is a normal occurrence at tech startups. The reason I’m more confident towards this reasoning, is that Stemson is going to be speaking at the Precision Evolution Global event in October, and wouldn’t make any sense to do so unless they were confident in their product (which seems to be the case based off their recent interviews this year).
https://www.linkedin.com/posts/precision-evolution-global-inc_innovation-drugdiscovery-drugdevelopment-activity-7196502232769384449-YXWc/
But again what do I know lol.
YoYo thank you for the updates on Stemson. In your perspective when can we see an actual released product? 2030?
I don’t know, 2030 would be if things were to move smoothly. It honestly depends on where Stemson ultimately decide to conduct their trials. If it’s in Japan, South Korea or Australia for example it would be a lot better timeline wise. In USA, I’m not sure. However, with the introduction of something like Pelage or Amplifica it would greatly benefit hair loss suffers as (potentially) they can cause massive hair regrowth by “awakening the hair follicles”. We could use something like that alongside a decent hair transplant it would cover some serious ground. Remember Pelage’s goal is to be able to be the first drug that is “regenerative” which Min. or Finasteride are unable to do. But Stemson would be the ultimate “cure”. I’m still not sure on whether I should be more excited on Fukuda or Stemson, all depends on results and timeline for me.
Thanks, can you see this coming out fairly soon (in your expertise) I don’t follow hair loss news too closely but always check this website and your comments
Appreciate that, but it’s honestly difficult to answer. I would say for really good treatments to come I would say 2027. But for a cure I’m guessing between 2030-2032. But Fukuda did say that they will be able to release their product in the next several years, so who knows lol.
Thanks YoYo :)
Thanks!
I live in Los Angeles and will email them to see if I qualify. I do take Fin and oral Minoxidil, hopefully that doesn’t disqualify me.
Oddly, the study does not list as a primary or secondary outcome of the study an increase in terminal hair. The primary outcomes are listed as 1) percentage of subjects with treatment-related adverse events; and 2) Change in local dermal tolerability. The secondary outcome is listed as the assessment of concentration of PP405 in plasma. I recall Pelage referring to this as a phase 2a study in one of the press releases earlier this year. I hope this doesn’t mean there will be a phase 2b study before they get to phase 3.
Great observation Pinotq.
Pretty sure there has to be a 2b trial then with assessment of TAHC before moving to phase 3. No sense in moving on unless you know it grows hair, right?
Not happy about that.
Any topical treatment done at home will definitely not be a real cure. The actual treatments should be done in the clinic by the doctor. Pelage will not be better than min or fin. Expectations of a topical treatment performed at home should be reasonable.
Everything we know so far shows that Pelage has definitely the potential to be a cure or close to it.
„Pelage is pioneering an innovative approach with the potential to disrupt the treatment landscape, moving beyond agents that merely slow the progression of hair loss to a treatment solution that actually helps to regrow hair.”
“This therapy represents an exciting new option for not only treating but reversing hair loss. We look forward to advancing PP405 to Phase 2 clinical studies this year.”
Ben I disagree with you and I believe you are overly optimistic about Pelage due to its mechanism of action (which has an excellent and advanced mechanism of action). Time will tell if my prediction is correct or yours…
Understand the skepticsm..but it is interesting that this drug’s mechanism of action is to activate hair follicle stem cells, as far as I’m aware this is the first drug to activate the stem cells…so will be interesting to see how it pans out
Like Ben and YoYo, I am more optimistic about Pelage, for the reasons mentioned above, than anything else in the overall pipeline at this time. That doesn’t mean it won’t fail…..maybe it will turn out than not 1, but 2 or 3 pathways need to be turned on. Maybe 1 pathway only turns on enough to grow a vellus hair, or maybe the hair is terminal but only lasts 3 months. Who knows? That said, I don’t see how the fact that a treatment can be administered at home vs a doctor’s office has any scientific relevence to its effectivenss.
Baldness is not a simple problem that can be solved with a pill or a topical solution that can be done at home. You are not talking about the flu, you are talking about one of the most complex parts of the human body, «the hair follicle», which has many unknown aspects. To solve the related problems, complex and advanced methods such as gene therapy or pluripotent stem cells or treatments that should only be performed by a specialist should be used. With today’s human knowledge, no complex disease can be fixed with a simple method like rubbing and massaging a gel (!!) and it will only be a temporary solution like fin or min. Unfortunately, some facts are difficult to accept…
Looks like you’ve got it figured out Roman!
https://www.youtube.com/watch?v=m7IuuOWqDPQ
Pelage has updated their clincial trial page and, as of their July 1 post, has begun recruiting at all trial locations. They certainly look like a very well organized and efficient company, quickly delivering on their stated goal of launching a phase 2 trial in the second half of 2024. Great sign but still a very long way to go as this is only a phase 2a trial.
Did you see this press release admin, perhaps further validation of the concept?
https://www.manchester.ac.uk/discover/news/surprising-link-between-ancient-biology-and-restricted-human-hair-growth-found/
Pelage has updated their website if you scroll down to “The Pelage Solution”. They mention about their Phase 2 trials.
Well on that link to „Clinago“ it says phase „2 b“ now, on the website it’s „2 a“. I‘d prefer the former, otherwise there’s another extra trial.
I would like to now how many participants and the other arms.
The good thing is that this trial finishes this year, if we‘re lucky we also get the results in 2024. Fingers crossed!
Yup, I just hope we get to see pictures too :/
Interesting observation that they say 2b on Clinago vs 2a on clinicaltrials.gov. On clinicaltrials.gov (CTG), it says “The study is designed to validate safety results from the Phase 1 PP405-001 trial while also characterizing longer term safety and PK following 28 days of administration” The primary and secondary outcomes they list on CTG are also only safety related. But I noticed on Clinago they say “The main purpose of this study is to evaluate how safe and effective the investigational drug PP405 is”. And they clearly state they will take photos at 16 weeks. CTG still says its a phase 2a study but this leaves me wondering if ithey might be modifying to a combined 2a & b study. On CTG, they say the estimated enrollment is 60.
2024 and Im calling now that this will fold after a few years of delays, hype, missed endpoints, and nonsense.
@pinotq: What is your opinion on the type of sugar that they have found is beneficial for hair growth? Optimistic? If effective, will it take 5 years to get to market even though it’s a natural substance?
It is likely nothing much. But for those interested:
https://newatlas.com/medical/baldness-sugar-hydrogel/
Added a lot of new members and names onto the website. They’re definitely serious.
Most of these people have been in the company for quite some time (except the advisory board of course) – Sun and Flores since 2018 (!), I think the newest is Weng as CMO.
I still think it’s a tragedy that Pelage was in hibernation for 2 years due to lack of funding – only after Daniel Gil took over in 2021 things got traction.
Are you sure Ben? There were some members under “Team” whom I never heard of before
First patients dosed and new Finance
https://www.prnewswire.com/news-releases/pelage-pharmaceuticals-advances-clinical-program-with-first-patients-dosed-in-phase-2-study-for-hair-loss-and-gv-led-14m-series-a-1-302220301.html
Daniel Gil makes no jokes, this is FU-money in the world of hairloss. If I am correct, no company or start-up has ever accumulated more money than Pelage, including Stemson and Exicure.
They must be extremely confident that this works.
Given that this is „only“ a topical molecule in comparison to Stemson (cell-cultures, devices to extract and implant, machine learning, etc) they must already plan a phase 3 with this money. A 60 patients-trial cannot cost more than 16,75 million.
Anyhow, as money is the limiting factor, they are definitely not limited. Great news.
I wasn’t gonna share this, but I will. Best to keep expectations low. I tried to get into one of these trials and the person on the phone said they were only taking people who started losing hair in the past 5 years. It was also implied that the gel was for the crown and not the hairline. I might be wrong about that 2nd part but 100% said it was only for people losing in last 5 years. I take no joy in sharing this news but I gots to look out for my bald brothers and sisters.
That’s not true. I have been losing hair for 10 year and was accepted as a candidate as a NW4.
Would be great if you could update us on your progress?
The community would be grateful…a beacon of hope in sparse times.
@fake name when do you begin the trial?
Well you had a very different experience than me. I was told “good news, bad news” and told the 5-year thing. That said, I would advise against leaking anything that happens to you with respect to results. That’s what got that HMI guy on Tressless in trouble and almost got that entire trial reset. Best of luck though. I hope it works.
That does make sense to be fair, as they went to test the parameters and push it in their 3rd phase. But I wouldn’t be too worried about that because they’re trying to advertise it as hair follicles being present on your scalp and it’s just a matter of reactivating them. So we’ll wait and see but I don’t think it’s gonna be a hindrance just to have a gauge more so than anything.
Hello everyone!
According to the information on Pelage’s website, it sounds different. Perhaps Pelage should comment again himself. Or have I misunderstood something? Perhaps someone can explain this to me.
Why would they then ask for your NW-status (up until 7) in the application-form?
Wouldn’t make sense. They probably try every NW.
They ask for up to NW7 so people will give the most accurate answer for themselves and then they exclude people beyond a certain grade.
That actually makes sense, LJ.
Well, as with every medication against hairloss – they work better with lower Norwoods or in the earlier stages. This probably guarantees better results which are crucial for future funding. I‘m fine with that.
Regarding the comment of that user further up („Fake Name“) I advise every reader to remain skeptical of these comments – there have been too many trolls in the past.
A. I feel like a troll would say this definitely works knowing that it’s going to hurt more when you believe in something and it falls apart. I’m just saying keep expectations low. I literally hope it works but I don’t think it will.
B. Bro, you could just fact-check me. Fill out the form yourself and when they call see what they say.
They’re probably trialling it on the NW level they believe it will have the best effects up to, but I imagine if it’s approved as safe and effective for this many people with more advanced HL will use it ‘off label’
I studied all the clinical trials that used induced pluripotent stem cells to treat heart diseases, and interestingly, none of the clinical trials could treat heart disease with ipsc injections! Only iPSC injection caused mild to moderate improvements in heart disease progression. I said this to come to the conclusion that the reason Pelage raised a higher budget than Stemson is exactly this. Despite the very high cost, IPSC absolutely does not cure diseases (including baldness). For this reason, Stemson has not started clinical trials. But pelage can be an effective solution, although I believe that pelage is not only not a definitive cure, but it is not even close to a cure, but it is definitely stronger than fin and min.
I’m not sure about that take bill
Here’s the last I’m going to say about this subject. Here’s a comment from someone on Tressless (not me):
“I signed up for this trial and met with a participating dermatologist. They rejected me for 2 reasons; I’m currently taking min and fin, and I been experiencing mpb for longer than a couple of years.
Honestly could have saved a lot of time if they added a couple questions to their survey.”
Fin and Min is a standard denial, the FDA is never going to allow trial subjects on Fin and Min to be a part of a data set, but the MPB timeline is interesting. Maybe they are spliting up the data sets into more recent and further away MPB candidates?
I said I was done posting on this subject but let me try and give a rallying speech here.
All these companies make the same sorts of promises and yet they’re always letdowns. Pelage’s site clearly implies it’ll work for anyone and yet their actions say otherwise (in addition to their trial rules there was also a presentation given earlier this year that said it was for NW 3s-5s). Stemson is clearly dialing back, and Amplifica is MIA and will likely be a similar story as Pelage.
That said, I think there is hope. The irony of this site is that it’s called HLC2020…maybe there’s close to a cure already available and you can start working on it now.
If you want to stir up your stem cells try microneedling. Use topical fin/min or oral min to regrow. If you get enough regrowth get a transplant on the corners. Like getting into shape, it’s a process. Like brushing your teeth, it’s a daily thing. Just stick with it and see what happens instead of waiting for clinical trials for drugs that are ultimately disappointing or holding out hope in companies that repeat the same lies. People who can’t lose weight usually give up or cut corners. Why not just stick with a routine for awhile and see if it does anything for you?
Don’t know Fake, the study eligibility criteria mention the limitations regarding NW level and conmeds, but nothing about AGA duration….
https://clinicaltrials.gov/study/NCT06393452
Hey Fake Name, am I the only person who isn’t willing to mess with my hormones? Yes, my hair loss affects my mental health daily, unfortunately. But these new medications are the only hope I have remaining.
I mean, I don’t know, you’re probably not the only person afraid of that. You could give topical fin a shot and see if it works.
My real issue is these companies who pretend to find some amazing breakthrough and it’s no better than fin and min and we wait for years for a dud. My point is if you want hair use the tools available now, don’t let the years go by.
Im somewhat confused on the action mechanism. Is the goal to stimulate the stem cells that generate hair which are thought to be shut off due to DHT? Would this potentially color grey hair as well? What are the risks they are looking for?
Here is a link to an interview with Christina Weng: https://www.dermatologytimes.com/view/q-a-pelage-s-novel-pp405-advances-to-phase-2a-for-androgenetic-alopecia
There is more detail than I have seen before but maybe the most important is that she confirms that one of the endpoints of the phase 2a study is efficacy……….despite that not being mentioined in clinicaltrials.gov: “One of the end points that we’re looking at to assess is efficacy of hair growth. We’re doing 3 different measures of hair growth. First, we’re assessing what’s visible with the naked eye. Second, we’re using high-resolution photography to quantify hair growth at the single hair level. This allows us to identify changes in density in a very objective way. Third, we’re collecting tissue, and we’re able to assess markers of hair growth at the macroscopic level. Designing measures of hair growth across the full spectrum of microscopic to macroscopic was very intentional, and it gives us a more holistic picture.”
It’s strange because efficacy is mentioned in the title of the study on clinicaltrials.gov but you’re right the study record does not seem to list any efficacy endpoints….
https://www.clinicalleader.com/doc/pelage-embraces-diverse-patient-recruitment-for-non-hormonal-hair-loss-therapy-0001
Thanks YoYo, very encouraging.
I guess everything has to be diverse these days – I don’t know how that’s important for a trial, the stuff works or not, simple as that. If you’re black, white or Chinese, who cares? The MOA of Pelage is stem cell activation – so it’s even less important to include diverse participants imho.
This is plain virtue signalling.
I also don’t believe imaging technology has ever been a problem – medical photography and imaging has always been way better than anything’s in civil use.
Anyhow, please be woke, as long as you deliver our homerun, I don’t care!
Btw the only reason Pelage is not available already is AbbVie‘s purchase of Allergan. If that would not have happened, Allergan would have financed all trials. Instead AbbVie decided to terminate the option. How cynical is that lol.
True, I did not think of virtue signaling till you pointed it out.
Having said that, the Folix laser for hair growth (that I discussed earlier this year) is not meant to be used on dark scalp skin.
Also, based on my “long-term amazing finasteride results on Japanese men” post, I think there are racial/genetic differences to hair loss treatment responses.
And many people say that PRP works better in women than in men.
And somewhat related, for laser hair removal, skin and hair color are of paramount importance. Dark skin gets permanently burnt and damaged with the wrong laser. White hair cannot be removed with laser, the last time I checked a few years ago.
I just love these casual criticisms of woke. When I ask people to describe woke, and add that they can’t use the word transsexual, they suddenly get all tounge tied. Woke was first used by 1920s blues musicians as a reminder for Blacks to stay vigilant. Naturally right wingers try to reframe and appropriate the creative use of language to compensate for their own inadequate forms of expression.
For the love of Pete, can we not turn this into a political blog? Not directed at anyone, is directed at everyone.
Yeah I will not approve most of these any more.
That’s great news Admin. I think we’d all appreciate it if you could keep all the nutty virtue signaling and biased politics out of here, or I’m afraid we’ll lose a lot of readers.
Poor those investors who lost their money in the way of pelage company. Activating stem cells by increasing lactate is a stupid idea and doesn’t work. I wish they would give their money to Stemson.
I also agree with you. Pelage is bs. It is interesting that the capital received is even more than Stemson and its investors are really stupid.
Exactly David. Refreshing to hear someone being realistic. Nothing of substance will come out of Pelage.
Yes dhtterminator, it should be realistic. Most companies are just looking to fill their pockets without providing an effective solution. Of course, I have a lot of respect for stemson because I see that they are really looking for hair loss cure, but their progress is very slow and that is not good at all. I wish these companies would find a drug delivery system that would prevent systemic absorption of topical drugs. For example, suppose we take topical dutasteride at a very high dose without detectable systemic absorption into the blood. But unfortunately, no one follows it.
Yeah, it’s weird to me too that they raised even more money than Stimson.
I always wonder if these investors have sense.
do they think?
Who advises them?
The idea of activating stem cells is good, but not by increasing lactate. pelage has only one positive feature, and that is their good speed in starting clinical trials, which makes them declare failure faster after announcing their disastrous results. It’s good that they don’t make fun of people like some companies for years!
What an exciting discussion I love it here because the admin doesn’t censor comments and that’s great. thanks admin. I think stem cells remain in bald people’s scalp for a long time, but after a while, they disappear forever. So activation of stem cells does not work for everyone. With the research I did, I came to the conclusion that the increase in lactate instead of activation, causes the inactivation of stem cells! I prefer topical exosomes to pelage, but I don’t know how much they absorb through the skin without microneedling.
To be quite honest I’m surprised there isn’t much progress in also finding ways to regrow dead/lost ground, such as for the hairline for a NW3, or better yet for a NW7 throughout the top. I hope we are all just being pessimistic, but there have been so many disappointments this year.
I will be participating in Phase 2 trials. I will update here with info and links to pics if I’m allowed. I have this page bookmarked. Really REALLY looking forward to the possible results!
That is amazing!!! Keep us posted
Not as interested in pictures as a better understanding of the action mechanism. Is the goal to reactivate stem cells in the hair that are inactive?
That’s right AM
Seems like the study has finished recruiting patients. The clinicaltrials.gov page changed the status to “Active, not recruiting”. And the Clinago page that the main website links to no longer exists.