I first covered Swedish company Follicum and its FOL-005 hair growth product exactly two years ago. I wrote another post on the company early last year. Thereafter, I have only covered them in passing as part of my once a month “brief items of interest” posts.
Most recent developments were minor and related to country specific patents and so forth. My main reasons for following this company are due to the facts that they are conducting their research at the prestigious Charité Hospital in Berlin, Germany; they have an impressive group of hair loss related scientific advisers; and they have been providing us regular news updates.
Follicum 2016 Annual Report
Earlier today, a person by the name of “Rickard” e-mailed me and asked me to check out Follicum’s latest report. When I then went to Follicum’s website, the news section had not been updated since last year, while the press release section had several updates from last week, one of which was the release of their annual 2016 report. It is in Swedish, but can be downloaded and then translated via “Google Translate”. I learnt some interesting new things in the report:
- Follicum was founded in 2011 based on research from Lund University by Anna Hultgårdh Nilsson and Pontus Dunér.
- The company’s technology entails isolating the protein osteopontin, which regulate hair growth.
- “FOL-005 is a section of the protein, gathered in a small molecule (peptide) where two amino acids are deleted and replaced by a third”.
- Company inception (2011).
- Preliminary study on live mice (2012).
- Study on human skin in vitro (2013).
- Study on human skin transplanted to mice (2015).
- Toxicity study for three months (2016).
- Clinical Phase I study of subjects (implemented 2016-2017).
- Clinical Phase IIa study – a limited effect on the study subjects in the phase I study (2017).
At first, I was not sure about writing a new post on Follicum just because of the above annual report. However, thanks to commentator “Hopeful” posting this new link, I realized that this was probably what “Rickard” was talking about earlier.
Clinical Study Shows 8 Percent Hair Growth
After translating this new link, it seems like Follicum’s FOL-005 resulted in an 8 percent increase in hair growth in patients treated at the Charité Hospital in Berlin in phase I/IIa clinical trials. CEO Jan Allenfal states that this compares favorably to existing treatments that results in a 4-14 percent average increase in hair count. With further testing and experimentation of dosage and composition, FOL-005 is likely to results in even superior results.
I think its great to get a third option to the two main current treatment options (Finasteride and Minoxidil). Even something new that only maintains existing hair would be very welcome (especially for those such as myself who are not keen to reduce their DHT levels for many years continuously via taking Finasteride).
However, will FOL-005 grow back hair in those who are already severely bald? Not likely.
116 thoughts on “Follicum Phase I/IIa Results”
At least better than nothing. Thanks admin for the news
Absolutely. We desperately need a Finasteride alternative. If one comes through within the next couple of years, I could take that, have a hair transplant to fix my hairline and thicken up my crown a bit, and I’d be very happy. Finasteride gives me terrible side effects and isn’t an option for me.
seriously finasteride is a joke. i hate losing my hair but no way am i going to sacrifice my sexual libido and all the other sides for that, and then one day stop taking it and have to go through the nervous breakdown of going bald over night
What I find very interesting is that they are working on both hair growth and inhibition. I always wondered why no one was working on the latter as hair removal is also a huge market, and if we learn how to make follicles grow hair surely we should learn the opposite, this makes follicum that little bit more credible to me. Excited to see this progress and hopefully this surpasses our expectations, either way a nice addition to the limited options we have coming up!
How does percentage work regarding hair, sorry just trying to understand how good that is.
ya, like say I have 50 hairs per inch sq. That’s like an improvement on average of 4 hairs lol…who knows what these “% increases” actually means.
@Guest99 don’t forget this is only an early phase safety trial so remember that! They weren’t even looking for full efficacy results so the fact they had 8% at this stage is very promising. Future trials will then look at the right dosing, application, and many other factors like number of treatements to get the most effective results. Let’s wait and see! And yes this is percentage increase in the test site.
Hey jay could you explain what do you mean when you say that they weren’t eve looking for full efficacy?
I mean, if they want to know the safety profile, they should test the product at the same % that they wanna sell.
Othrrwise they had studied the safety profile of a product (with different %) that they will never sell.
I really don’t know how these stuff work. Let me know…
The effectiveness of this will probably double if you are taking dht inhibitor like Propecia. They need to make it 20 to 30% regrowth. Then we got a game changer
How can they ‘make it’ 20 to 30% regrowth? That’s like saying why doesn’t Fin or Pro make it 50% regrowth. Anything that doesn’t use stem cells is going to be half assed no matter what it seem.
There are countless MTF transsexuals who have seen 50 percent regrowth…it is possible with current meds if you go in “all the way”.
I did not know that. That is one hell of a sacrifice to make though lol
The question….can have access to the details in order to make this molecul producted in other labs ?
Optimistic for this study
admin can you ask dr kemp for this link. we want to know when the clinical trials will start and if we can participate . thank you in advance
Few of those stories of late. Dr. Kemp is replying here:
That’s great news that they have something that works. Anything new that might actually make it to market is huge, it could push some of these other companies to get to market.
When is it coming out and would it be available outside Sweden?
Don’t know if this has been brought up before, but I’m curious as to what the community thinks:
Does not look like a real study. There was no subjects or control or placebo or anything. Seems they looked at a 2d picture and are guessing the areas with most pressure bald first.
Not that its wrong but it is limited to say the least. Another reason to take enough magnesium just in case.
They also suggest injecting botox on your scalp muscles to reduce tension
Magnesium? Just curious as to what that connection is.
Oh it helps relax muscles. The paper theorizes the scalp muscles are partly responsible for aga as they tighten the galea area and that the pressure causes the cells to react in a way that makes them more vulnerable to androgen signaling causing lack of blood supply and fibrosis over time.
I have a thought. Transplanted hairs do not shed. I am thinking the muscle fibers on transplanted hair follicles prevent DHTs effect on the follicle whereas the AGA affected hair follicle has a different muscle fiber that doesn’t get affected by AGA. Maybe they need to research on the differences of these two different types of follicles.
Maybe this is also linked:
Hello, this is off topic.
this is the first time i’m going to take finasteride
how to decide if I should take 1mg or the 5mg?
thank you in advance.
Hi, I took my first pill yesterday. Take 1mg max, 5mg is for prostate cancer. Usually people even advice to begin with 0.5mg so you get used to it easier. Also 2 posts before this one you can find a thread where the accuracy of 1mg dosage is questionned, seems like smaller dosage could reach the same effect on hair loss while reducing risk of sides but it will last a few more days/weeks to reach its right level in your blood
LOL in all posts the same xD delete the off topic admin.
Tim don’t even take 1mg, buy propecia and a pill cutter and cut one pill into 4 and start with .25mg per day before bed.
Why start with 1mg if .25 will work.
Is it working for you jj ?
8% on the scalp that keep less than 50% of your original born hair is nothing…..
If you stop hair fall will be good…. But i think stop the fall will be Impossible on the near future.
Lets hope this get in To the market to millenius…..
For us with more than 25 year old we are f…. If nothing real like clone happens.
Are you at all concerned that ken washnik is on the board for follica yet he also has interest in Bosley, a company that thrives on hair implants.. It would seem thats a conflict of interest.
Do you seriously think someone would intentionally hold back the cure to baldness just to sell more hair implants? You’re being ridiculous.
100000000% think about the market. No im not being “ridiculous”
@cory: the demand is huge. That’s the main reason why follica’s treatment RAIN will be released as soon as possible.
I think you mistakenly think follisca will be free
I wouldn’t be surprised if Bosley will be incorporating follica method into their clinics in conjuction with ht. Would make ht better option for all of us if follica cab actually yield 100cm2 hair growth. Add ht to the mix and you are talking about serious results.
MattFR Is it working for you jj ?
I started on a high dose and got sides so I dropped to .25 mg per day and it worked great for many years. Learned a lesson, more is not always better.
Thanks a lot for your answer ! Wise advice.
Wish you the best.
What kind os sides did you experiment ?
How much time does it take to notice them ?
Your damn hair follicles love:
No DHT sensitivity, higher PGE2 lower PGD2
Relaxed follicular muscles, lower tissue density/fibrosis
No autoimmune disease, inflammation
Proper stem cell differentiation by stimulation
Most of the above is probably irrelevant but one thing is for sure, evolutionary brain/skull growth led to the morbid problems of our present world (and of your scalp?)
May the billions of mice who were sent to nirvana by us, slap our foreheads until deep red burn, someday.
Looks as though their research stemmed from work on arteriosclerosis. Furthermore, apparently osteopontin plays a number of roles in inflammation, immune response, and wound healing.
More evidence that androgenic alopecia is a degenerative condition modulated by inflammatory immune responses? At least it places their research in context.
Isnt hair immune priviledged?
Not in the other alopecias. The privilege collapses.
what kind of alopecia? lol
I’m interested in this too, should all chip in and buy a tub and get NASA rs to test it on 3 or 4 specific places and report back fortnightly.
See that this percentage of growth is based on supplementing 3 TIMES A WEEK.
Minox is 2times a day.
They also tried a group with 2times a week, but 3times a week did show better results.
And now further they will try to adjust the dose.
Wonder how 2times a day will go :)
@Corey I also wonder how cotsarelis involvement with setipiprant trial affect his work or possible release of follica?
Yes, he has all these competing interests…. Exactly my point
On a prior thread Steve had an excellent post on how it appears Follica is using laser wounding with JAK’s.
Now I wonder who will be first Follica or Aclaris (exclusive JAK use) in solving hair loss. And we have Tsui probably right behind them.
This is the year we should know that AGA can be successfully treated. We are that close.
That doesn’t make sense given that Stat3 activation is important for wound-induced hair neogenesis.
You know what would be really hilarious…we are all watching tv at home and see a commercial for a new hair loss drug that none of has heard about. Hidden by us and just randomly released lol. Oh and the treatment grows backs 80% of your hair :)
So apparently this 8% follicum study was done on the thigh…
Yes and they state that Phase II trials will be on the scalp, potentially via nanoparticles.
Slide 16. Enjoy.
page 28, “Disruption + drug projected ~3-4X effect of currently available drug therapies”
also incase you are like me and don’t know what pivotal trial is: A pivotal trial is a clinical trial or study intended to provide evidence for a drug marketing approval, e.g. by the United States Food and Drug Administration. Phase III trials are assumed to be pivotal so the phrase is often used for the rare pivotal phase II trials. — Wikipedia
From an April 2016 posting on follica:. A separate clinical study, published by third-party academics, indicated that the combination of skin disruption and an approved hair-growth compound, minoxidil, showed a 4x enhancement versus the efficacy of the compound alone. [
Follica latest newsletter states a 3 to 4 increase in efficacy compared to current medical treatments which matches up the minox compound treatment as stated above damn im sad. Fat face he a palpitations minox. Gotta love it!
Hopefully not, minox doesn’t work for very long or long-term I mean…
I guess this means disruption alone was much less effective than disruption plis minox..
Disruption alone would be interesting to test
I dont like minox.
disruption has results so we can use any of or combination of:
Acutally good news but still not the cure for a NW 7… 3-4 times better results than current treatments. I know that this is good news but for all who are slick bald, its not the results they might have expected.
If your noticeably diffuse or slick bald only hair multiplication procedures like what Tsuji and Tissuse are really anything to hope for i think. Hairclone may come in at sometime but right now they are going the injection route like Histogen not making follicles.
Any idea how long Follica´s pivotal trial could last?
According to the FDA: Minimum a year maximum 4 years.
Best case scenario July/August 2018.
Thanks. I cannot imagine another 4 years. 1 year I think then another 6 months for bringing it to market. So maybe end of 2018
Do you really think 3-4 times more efficient than other current treatments makea sense?
If they can create new follicles then they actually can repeat the wounding process to create even more follicles? Short: Is there a limit of creating these new follicles?
3-4x more makes no sense. Based off what numbers?
So vague. Just show us a photo and let us decide.
I get no growth from anythong so 3-4x means nothing to me. Will it work for everyone or not?
That is exactly the reason why Cotsarelis has this big bald spot…. 3-4 more efficient compared to nothing 0,0000…. if this turns out to be really nothing than thats a shame….
With the time it has taking Follica to come this far we should probably expect the last trial to be long. Its nice to hope for 2018 but I dont see it happening. Also, the bald spot on Cots head….jeeez 10 + years researching a treatment that should create new growth and the professor behind it all is the living proof of what we should expect…the best promotion they could do for a launch would be Cots using the treatment on himself filling the bald spot with thick lush new hairs:-D Or maybe he already used it….
“Enhancing hair growth in male androgenetic alopecia by a combination of fractional CO2 laser therapy and hair growth factors ”
Clinical trial in China registered in March 2017
Looks like 31% difference
This 3-4x Times wouding process will not damege hair already in out head?
This will be like woman beauty creams…..
More evidence from Garza out today that backs up FOLLICA (not follicum):
After skin wounding, noncoding dsRNA coordinates prostaglandins and Wnts to promote regeneration.
Zhu AS1, Li A1, Ratliff TS1, Melsom M2, Garza LA3.
In a rare example akin to organogenesis in adult mammals, large wounds in mice lead to de novo morphogenesis of hair follicles. It is still not fully clear what controls this process, known as Wound Induced Hair Neogenesis (WIHN). In other tissues, prostaglandin E2 (PGE2) is an important effector of regeneration and has been shown to stimulate the Wnt/beta-catenin pathway, which in turn is known to control WIHN. Previously, our group has demonstrated that noncoding dsRNA released during wounding is both necessary and sufficient to stimulate WIHN through TLR3. Here, we hypothesize that dsRNA similarly induces the beta-catenin pathway through PGE2. We find that WIHN levels correlate closely to Wnt7b production in vivo, and that dsRNA potently induces Wnt7b in a manner that requires prostaglandin-endoperoxide synthase 2 (Ptgs2). The Ptgs2 inhibitor celecoxib reduces dsRNA-induced WIHN and Wnt7b, and exogenous PGE2 can rescue WIHN and Wnt7b. Although other wnts and pathways likely contribute, these results highlight noncoding dsRNA as an upstream coordinator of prostaglandin and Wnt levels in regeneration.
Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.
hair; regeneration; skin
Hi I deleted your second comment since it was way too long. Please do not paste whole studies…just paste the link to the study and a few key sentences if you want.
@GarzasIntern: Nice! All the studies carried out in the last 10 years for androgenetic alopecia, hair regeneration … are crucial for the next treatments that will soon be on the market.
What compound is follica using with the wounding process?
Seems its minox
But therrs probably more than 1 compound used
Thanks for the news admin.
Their lack of real progress however puts them out of the race.
The smart money is on Replicel. They got the tech and the money. Either their product will crack it by 2020 or if that fails it will be at least another 20 years.
Sorry, by Replicel I mean their cash daddy Shiseido.
reader here claims Replicel or nothing…smh
Hopefully they cracked the right dosage, frequency and injection depth since repli says multiple injections are optimal.
Good movement Follica…Anyway I do not think it is the first new generation treatment for MPB to reach the market…But…who knows… @Scott: Replicel either. Sorry man.
Repeal and Replace: Adipocyte Regeneration in Wound Repair
I could provide 100+ citations proving that follica is very much on to something. The science is very much there already. The question isn’t if a wounding protocol could provide a “cure”, the question is what that EXACT protocol will be… how, when, with what (laser or dermaroller) and so on. Follicum and Histogen and the others with “magic potion” injections will go nowhere (no farther than PRP). The only near-tearm hopes are (1) wounding, (2) actual multiplying (like tusji) or (3) JAKs. I think a follica-like solution or JAK may come to marketer slightly quicker than multiplying. Follica seems to be working on distribution where tsuji doesn’t have any branding, devices, or anything else together yet… plus theres more science to do before that marketing component.
Will Norwood 7 give her hair?
I think in heaven we have got all our hair back, and I am sorry for them who are going to lucifer;)
Interesting that “Rox” might be the real genius behind this.
The publishing of results soon sounds interesting.
Good stuff on pure tech article. Looks like follica will releasing some results soon. That would be pretty cool!
Follica is getting ready to publish some of the results of its clinical studies, and marching toward what it hopes will be eventual approval from the Food and Drug Administration.
See it soon
ps: sorry. I post it in the wrong article ;)
Here is the link: https://www.bostonglobe.com/business/2017/04/14/meet-one-most-important-medical-entrepreneurs-you-never-heard/dfZFRbcdtjLcqyxci9vKlM/story.html
Thanks Paul you do not have to say it regularly:-)
BTW — I deleted your latest link to the Hairclone article as it was already posted twice and I will discuss it in my next post.
Don’t worry admin. No problem.
FDA!! Oh I hope Trump’s much more freethinking candidate will finally arrive at that prehistoric organization.
They’d just be making us the lab rats. They’ll approve drugs as long as there safe and put them on the market regardless of how well they work for whatever and we’ll pay for them and test them out.
you don’t get it.. the goal is to make testing easier, cheaper and faster.. not to release unsafe drugs to the public…
I have to say that everything is pointing to JAK as a strong possible treatment for male pattern hairloss.
I reposted this prior post excellent post from Royaume see below for details:
April 11, 2017 at 1:25 am
Admin you said there is no proof that JAK works for AGA.
In one of your posts (briefs items of interests – februaray 2017) you quoted Dr.Neal Walker:
‘“Most importantly, androgenic alopecia. Even though that’s traditionally not thought of as an inflammatory process, what they were able to find is that the JAK inhibitors were targeting the stem cell compartment in the hair follicle bulge and actually prolonging and inducing anagen”.’
‘“Being covalently bound…its got a much better shot of not being as promiscous as the other JAK inhibitors“’
It seems that it has an impact on AGA? Its prolonging and inducing anagen… I really think that nasa_rs is right .
Another question: let’s assume they find out that it works (during their preclinical or clinical phase) What does this mean for us? Does it mean that the cure for AGA is a topical solution of Decernotinib?”
I can answer the last question from Royaume – Yes the solution would be a lotion on the scalp.
I hope Follicum results catch the attention of big players who can partner with them accelerate the trials and possible commercialization. Regardless, Jan Allenfal recently expects 4y best case scenario.
When will follica release the data?
Any dead line?
i found online a natural dht blocker called Dodder herb, or Cuscuta Reflexa, does anyone know more about this or tried it?
Just learned that daidzein and genistein (soy) were succesfully tested as inhibitors of the type 2 5 alpha reductase enzyme.
New hair supplement :
Topical dutasteride delivery method discovered:
Thanks, second one very interesting.
I have been following Follicum for a while and owns shares in The company. They definately have an interesting candidate in FOL-005.