Follicum Phase I/IIa Results

I first covered Swedish company Follicum and its FOL-005 hair growth product in this post from almost exactly two years ago, followed by another post early last year. Thereafter, I have only covered the company in passing as part of my once a month “brief items of interest” posts, since most new 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 fairly 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 (it was just a one sentence e-mail). 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. Its in Swedish, but can be downloaded and then uploaded and translated via “Google Translate”. I learnt some interesting new things in the report:

  • Follicum was founded in 2011 based on research fron 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 deleted and replaced by a third”.

Follicum Timeline

  • 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.

Follicum 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.

119 thoughts on “Follicum Phase I/IIa Results”

    1. 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.

      1. 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

  1. 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!

    1. 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.

      1. @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.

        1. 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…

  2. 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

    1. 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.

      1. There are countless MTF transsexuals who have seen 50 percent regrowth…it is possible with current meds if you go in “all the way”.

  3. 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?

    1. 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.

          1. 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.

            1. 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.

  4. 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.

    1. 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

  5. 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.

  6. 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.

  7. Admin,

    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.

    1. Do you seriously think someone would intentionally hold back the cure to baldness just to sell more hair implants? You’re being ridiculous.

        1. @cory: the demand is huge. That’s the main reason why follica’s treatment RAIN will be released as soon as possible.

    2. 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.

  8. 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.

  9. 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.

  10. Interesting.

    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.

    https://en.m.wikipedia.org/wiki/Osteopontin

    More evidence that androgenic alopecia is a degenerative condition modulated by inflammatory immune responses? At least it places their research in context.

  11. 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.

  12. 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 🙂

  13. @Corey I also wonder how cotsarelis involvement with setipiprant trial affect his work or possible release of follica?

  14. 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.

    Nasa_rs

  15. 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 🙂

      1. 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

  16. 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!

  17. disruption has results so we can use any of or combination of:
    sam
    histogen
    bortzu
    kelopesia
    replicel
    follicum
    topical finasteride
    minoxidil
    laser

  18. 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.

    1. 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.

    1. 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

  19. 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?

  20. 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?

  21. 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….

  22. 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….

  23. 1 question!

    This 3-4x Times wouding process will not damege hair already in out head?
    This will be like woman beauty creams…..

  24. 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.
    Author information
    Abstract
    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.

    KEYWORDS:
    hair; regeneration; skin

    1. 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.

    2. @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.

      Thanks.

  25. 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.

      1. Hopefully they cracked the right dosage, frequency and injection depth since repli says multiple injections are optimal.

  26. 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.

    1. 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.

    1. 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.

    1. 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.

      1. you don’t get it.. the goal is to make testing easier, cheaper and faster.. not to release unsafe drugs to the public…

  27. 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:

    “Royaume
    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?”

  28. Data backing Follica is below. I suspect they have more than just minox. They are trying to raise PGE2, among other things, during their wounding.

    https://www.nature.com/articles/ncomms14091
    http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0174389
    https://www.hindawi.com/journals/sci/2017/3738071/
    http://pesquisa.bvsalud.org/bvsvs/resource/en/wprim-877495
    https://www.google.com/patents/US20160310395
    https://academic.oup.com/asj/article-abstract/37/1/71/2705996/Micro-Needling-Depth-Penetration-Presence-of?redirectedFrom=fulltext
    https://www.ncbi.nlm.nih.gov/pubmed/20179271
    http://paduaresearch.cab.unipd.it/7469/
    http://www.freepatentsonline.com/y2016/0129046.html
    http://onlinelibrary.wiley.com/doi/10.5966/sctm.2015-0397/full
    http://www.research.ed.ac.uk/portal/en/publications/hair-follicle-bulge-stem-cells-appear-dispensable-for-the-acute-phase-of-wound-reepithelialisation(c607ce5f-2d5f-4b55-a6c9-6d8016f32210).html
    https://www.ncbi.nlm.nih.gov/pubmed/25866259
    http://www.hairlosscure2020.com/fractional-laser-for-stimulating-hair-regrowth/
    https://www.ncbi.nlm.nih.gov/pubmed/25945952
    https://www.researchgate.net/publication/280997806_Hair_growth-promotion_effects_of_different_alternating_current_parameter_settings_are_mediated_by_the_activation_of_Wnt-catenin_and_MAPK_pathway
    https://www.ncbi.nlm.nih.gov/pubmed/26818284
    http://onlinelibrary.wiley.com/doi/10.1002/reg2.38/references
    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4632811/
    https://www.ncbi.nlm.nih.gov/pubmed/26504521

  29. 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.

  30. Just learned that daidzein and genistein (soy) were succesfully tested as inhibitors of the type 2 5 alpha reductase enzyme.

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