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.
Update: March 9, 2024
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.
Pelage Pharmaceuticals Raises $16.75 Million and Phase 2 Trials to Begin in 2024
February 27. 2024
Great new update (h/t “YoYo”). 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.
February 17, 2024
Earlier today, 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? Their 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.
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.
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.
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?
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/
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!
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?