Follicum Phase IIa Trials Back on Track in Germany

Update: October 9, 2020 — Follicum has completed its over 200 patient enrollment in its Phase IIa trials for FOL-005. Treatment will finish in all patients at the end of January 2021. Results are expected to be announced in Spring 2021. So far, no adverse effects and no patients have discontinued with their participation in the trials.

Update: June 8, 2020 — Follicum chief business office Mr. Gunnar Gårdemyr just sent an encouraging e-mail, part of which I am pasting below. Note that these Phase IIa trials entail topical application of FOL-005. In two prior trials, FOL-005 was administered via intradermal injections.

Follicum Trials to Restart

“Some good news. We will restart the clinical Phase IIa study with a cream-like formulation of FOL-005 this month, following a pause due to the Covid-19 pandemic. To increase the recruitment rate, we have contracted a third study centre. The study comprises approximately 200 male patients with hair loss who are treated daily for four months with the newly developed formulation of FOL-005 or placebo.

The study is being conducted at the Clinical Research Center for Hair and Skin Science (“CRC”) in Berlin; proDERM in Hamburg; and the new center, CentroDerm in Wuppertal. The patients themselves will apply a cream with three different strengths of FOL-005 or placebo in the scalp, once daily in the evening. The study is expected to be completed and the results communicated in spring 2021.”


Update: March 19, 2020 — Follicum’s Phase II Trial is delayed by the COVID-19 pandemic (h/t “Red”). Not surprising. Mr. Gårdemyr’s prior response (see last half this post) suggested that all patients were already recruited. However, this latest new link mentions patient recruitment as “going well thus far”, but not yet complete.

I suspect that most hair loss related clinical trials in the world will be delayed by at least 3-6 months due to the Coronavirus outbreak :-( And that is a best case scenario. The only good news this week seems to be a cessation of new COVID-19 cases in China.


Follicum FOL-005
Follicum.

February 1, 2020

I have written about Sweden-based Follicum and its FOL-005 hair growth product numerous times. Several days ago, Follicum’s CEO Jan Alenfall announced that German authorities have granted the company approval to commence Phase IIa clinical trials for FOL-005. The go-ahead was granted by the German Medicines Agency (BfArM) and the German Ethics Committee.

Also see this recent article titled: “The rise of therapeutic peptides: Follicum at the forefront.” Key quote:

“Peptide-based drug candidates are more likely to reach the market compared to small molecule drug candidates.”

Follicum Phase IIa Trials in Berlin and Hamburg

The trial will comprise about 200 patients who will be treated with topical FOL-005 or placebo daily for 4 months. Results will be released in the fourth quarter of 2020. The upcoming phase IIa study will investigate the safety, efficacy and response to a topical formulation of FOL-005. Note that in 2018,  an injectable version of FOL-005 produced a good safety profile and hair growth results.

The press release states that patient recruitment will start soon. I contacted Follicum to see if any of this blog’s European readers would be able to volunteer as test candidates. However, the company’s chief business office Mr. Gunnar Gårdemyr replied in the negative. He said that all 200 test male patients for the trials have now been recruited and are from Germany.

The trials will be conducted at:

  1. Charité Clinical Research Center for Hair and Skin Science (“CRC”) in Berlin. A highly reputable institute that I have covered in the past on this blog.
  2. Hamburg-based proDERM, which just celebrated its 25-year anniversary. The have an interesting website section on hair care and hair removal.

About FOL-005

According to Follicum, FOL-005 is a proprietary peptide. Its development was based on research involving the human protein osteopontin. FOL-005 is a shorter sequence of osteopontin. The sequence has been slightly modified, but is still based on natural amino acids according to Follicum.

83 thoughts on “Follicum Phase IIa Trials Back on Track in Germany”

  1. 1 year fir this trial, plus 3 years phase 3 including red tape, manufacturing, distribution, Fda process etc probably 2023ish

  2. Admin,

    I have a respectful request / suggestion.

    When you discuss prospective treatments that have been discussed before, would you be able to include a very brief summary in brackets after the company’s name?

    For example: “This article will discuss Strand Stimulator (Scalp injections that use stem cells, hoping to stimulate existing hairs)”.

    From time to time, I am unfamiliar with the specific nature of the treatments that are being mentioned, and I occasionally see people asking for clarification.

    I hope this doesn’t sound cheeky. It certainly isn’t meant to! You do a great job, and I think I speak for everyone when I say that we are very appreciative of the site and the work you do.

  3. Random question for any diffuse thinners or hairloss styling gurus:

    I comb my hair from side to side. When my hair is cut shorter, it tends to stick up — especially at the short side.

    Nothing makes it sit down for long. Water does, but as soon as it’s dry, it lifts up again. Hair spray sort of does, but random hairs stick stick up. I often use a hairdryer (cool and hot) but that doesn’t stop the hair from sticking up. Leave-in conditioner works at first, but a few minutes later my hair sticks up again.

    Any tips or advice? Any products worth trying?

    1. Paul, I do the same thing and I have great success when I use wax or grooming cream. Works great, gives a decent hold without having that wet, gelled look that makes your hair look thinner. I get out of the shower, dry off a little bit, and then apply it while my hair is still damp. The trick is to apply it to the scalp and then ruffle it up into the hair so it distributes evenly.

      Sounds ridiculous but lately I use a hand lotion called Midsummer Night’s Cream from trader joe’s and it works great. My stylist recommended it, said it was basically just unscented grooming cream.

    2. No worries. Will try once in a while, but do not want to be repetitive either. In this latest post, I mentioned what FOL-005 is about at the bottom on purpose, even though I have discussed the product many times before. FYI — I assume you check out the “Categories” menu for the company or product name to see all past posts too?

      1. Admin,

        I did see your description at the bottom, but to be honest, I still don’t really know what it is!

        Yes, when I don’t know what the product is, I look back at previous posts.

  4. I have the opposite effect, my diffuse hair stays down when I need it up. I spend 30 to 45 min each day blow drying and getting it right.

  5. Indeed peptides are the way to go, there was an amazing natural peptide discovered recently capable of counteracting the damage of DHT:

    https://www.ncbi.nlm.nih.gov/pubmed/31729428

    However it will fade into obscurity as always, because no one is going to make a product out of anything natural. I have used a lotion containing the fruit it was made from and it stopped my hair loss, however there were numerous other compounds in the lotion which are DHT inhibitors. As the study above supports this peptide in its pure form could stop the hair loss without any side effects, if only it was available for purchase as a research chemical.

      1. Basically same as what “SomeGuy” wrote :-( I am also pretty sure that I have read a number of articles in the past about japonica fruit extract and hair growth. We also already have the renowned anti-DHT Saw Palmetto natural product.

      1. I don’t see the Trapa Japonica in the list of ingredients of the Dr. Pelo treatment. Would there be anyway to purchase the fruit extract?

        1. It does list Trapa Japonica fruit extract as an ingredient. Interestingly it says to apply half the bottle for every usage.

          1. You are supposed to apply half a pump (the little pump thing on top), not half the bottle lol. And the Trapa Japonica it definitely in there, it says so on the packaging of the actual product Probably something got lost in the translation from Korean.

  6. Oh, for the love of God treatment is always 2-3 years away. 2 or 3 years pass and nothing. Then they say it’s 2-3 years away. So frustrating.

    1. With Respect…. the only people who are saying its 2-3 years away are us. We need to stop guessing on timelines and just let it happen. Stop worrying so much about it. If it happens it happens, if it doesn’t it doesn’t.

      1. It’s a partnership. They should have included a status update as they did last November and have always, don’t you agree?:

        “With the completion of the Japanese RCH-01 study earlier this year, RepliCel is now actively engaging Shiseido to deliver the study data and reach a resolution to the dispute between the parties. RepliCel is eager to end the ongoing dispute and work with Shiseido to commercialize RCH-01.” (November 2019)

        3 months later and nothing. Perhaps they haven’t figured out how or when to say it showed only marginal improvement and is not worth pursuing. I recall the lacklustre results from the first trial being blamed on the study’s objective—that it was more about safety than growth—and that an improved formula and their injector would yield greater gains. 5 more years maybe?

  7. There will probably be no cure this decade. Even a breakthrough discovery would be great, if it happens.
    Start using dutasteride or finasteride and assess for a while if you can tolerate using either of them. Maintain what you have, if you are lucky regrowth will occur too. Hair transplant is also a great option for guys with enough donor hair.
    Dont wait. Take action. You will thank yourself later, believe me.

    1. Steve, I’m looking to get get fue in the hairline to fill in density. I’m looking at rahal, konior and Hassan wong. Looking into couto but 4 yr long wait list. Who do you recommend? Looking to fill in right side of hair line where it has been much worse. Been on fin for 18 years and rogaine for 6. Slowly losing ground but mostly diffuse but not see through on top just front hair line.

      1. I cant recommend any of them since I dont have a lot of information regarding their previous works. But fue is an effective option to increase the density and cover bald areas.
        But I would recommend using dutasteride first if finasterides effectiveness is wearing off.
        For a lot of guys dutasteride is effectively the cure. Dont listen to folks saying you should use it every other day or once a week, take it everyday if you decide to use it.
        There is a great possibility that dutasteride might work for you and all that you have to worry will be taking the pill.

    2. @Steve Harrington “There will probably be no cure this decade” get out of here with that negative shit That doesn’t help at all. We have a greater understanding of male pattern baldness Now then ever before and hair cloning will be available this decade! This is not the 80s,90s and early 2000s it’s 2020 we have the technology now and we are so close.

      1. I dont know how do you define “cure”. If you mean its a one time solution like a pill or a single procedure that will take care of hair loss for the rest of your life then NO. But better treatments will probably come in the near future. And no, we still dont have the proper knowledge to combat hair loss let alone cure it.
        Thinking that a cure will come out soon is just wishful thinking.

        1. Steve Harrington a pill would be a treatment not a cure. Hair cloning would be the cure. And you may need more then one procedure to cover your whole scalp that’s fine It’s still a cure.

  8. Just to make a more positive comment. InSilico Medicine is an AI based biotech company who might be the true savior. Let me explain why. They developed since 2015 AI tools so that we can create a drug/treatment in a matter of weeks/months instead of years. Using their own AI they have already a treatment for hair loss in phase 1. The second point is that they are in early stages of using this AI tools to predict and replace the long & costly cliical trials, reducing the 10 years trials to a mere year or two. This is will ready by 2025 in my opinion. It took them 3-4 years for the drug discovery, probably the same amount of time for replacing clinical trials. That means that instead of 15-20 years from lab discovery to market release, it will only take 2-3 years very soon, and cost millions instead of billions. That will apply not only in hair loss but all aspect of medicine.

      1. More just A than AI. I am in this field.
        The term AI is often overstated these days because it is a buzz word. Rather how anyone seeking investment in 1999 would get it if they just put dot com after their business name.

        1. yes but do you think we’d be able to fully simulate lab results or drug trials by including all the relevant genetic and information and run trials just like they’re on a more crude level able to do flight simulations for pilots? Isn’t the possibility of quantum computing and knowledge from crisp-r going to merge with computer science? Wouldn’t this at least help bring things to the market faster as well as improve scientific discoveries in this field?

          1. Not really. People act as if simulation technology and AI are new things that came out last year. I did neural networks back in 1999. It’s how they program bad guys in computer games to be slightly more intelligent when you switch from easy to medium to hard level. Quantum computing, another buzz word, is also just as old. Both of them were good, both were used, but neither set the world on fire.

            The most productive approach is to always test on humans, much more humans. Instead of 2 dozen people in a lab, what about 20,000 covering every variation of genetics within reason. We would have cures to cancer by now.

  9. Am I the only one on this Blog freaking out that it’s Feb 2020 and we heard NOTHING from Tsuji and related companies so far ? Weren’t they supposed to have some clinical results by now?

    1. Red get used to failure, delays, false promises within the hair loss industry. Don’t get attached to any company for your own good. Replicel was supposed to have an update back in July. They just had a press release update with no word of rch101 lol. It’s a giant joke. Take big 3 and pray it works

      1. Replicel is literally the new Histogen, a running joke they r pathetic..Running a Phase 1 in 2020, I’ve personally been following them since 2013

        1. Me to Mutruk. I was so excited when they said they would release in USA 2015. They had great hair count results over a year from baseline with just two injections. Like an extra 30 hairs cm2. This would have been a great treatment, easy and no daily topical. Unfortunately they are back at square one. I’d say 2030 before they release anything or go bust.

    2. I was always a firm believer that the cure for hair loss will come by sheer luck.
      The scientists simply dont know what exactly causes male pattern baldness. We know dht plays a significant role but aside from that anything is just a wild guess.
      Even the big three were found to work on hair loss accidentally.
      The only available options are using the big three or hair transplant. Anything else is simply snake oil.

  10. Hello Admin.

    Sorry for the unrelated comment but thought I’d share.

    Like everyone I was encouraged to see Organ Technology’s new website a few weeks back, but have been curious/concerned about their partnership with Kyocera (announced in 2016, Kyocera ). Quick searches have revealed no news or announcements from K about their work with O.T, and the O.T site only mentions a ‘contract manufacturer’, (who isolates, cultures, and amplifies biopsied samples to generate follicle germ units via the organ germ method.)

    Seeing as Kyocera is crucial part of the Tsuji rollout puzzle, and as we’re waiting patiently to be thrown a bone of any sort, I made a polite enquiry to Kyocera, paraphrased as follows:

    “I wish to follow up on the status of Kyocera’s partnership with RIKEN  and Organ Technolgies – the Joint research project announced in July 2016. Specifically, Kyocera’s key role in the “Development of cell processing devices, etc.”

    I received an answer a few days later. Its typically polite and typically vague and non-committal, but the good news is that the partnership appears intact, and they seem to be progressing. The not so good take-away is that the progress is obviously not as swift as we’d all like – they’re still prepping for clinical research.

    Anyway, here’s the message back from Kyocera.

    “We are in preparation progress for the clinical research thus we would not be able to disclose any details at the moment. We hope to make an announcement in the next stage but the timing has not been decided yet.”

    Apologies again for the off topic comment Admin, but this is the only HL blog/site I’ll ever come to and thought you might be interested.

  11. Follica next year will be next out, 99% sure of that happening. Will be an enhanced process to micro needle with topical. A small, very small step in right direction. Awaiting more results for Exosomes, but can perhaps add a marginal benefit.

    DHT oral (1.25 mg proscar….big believer in brand vrs generic) daily
    Compounded 82f as topical with 5% minox
    Oral Minox 1.25 daily
    Keto shampoo
    LLLT (why not….)
    Daily Vitamins/Fish Oil

    this is what im currently on as a regimen, good results last Jan with PRP/SVF Stem Cell procedure

    1. Hey Live your life how is 82f working for you. One of my friends is using it and got good thickening the first few months but it ended up not being that effective. He is on rogaine and propecia for several years. I was thinking of trying it since I use rogaine foam and propecia.

      1. mjones, so far ive only been on for 16 weeks. i think its performing well thus far. i order mine from Dr Lam in Texas. They ship from Master Pharmacy in NY. Spoke to the PharmD this week and he shared they are using a new formula with solid results. Its a nice add on as I felt I would cover my bases with and oral and topical. I have been on finasteride for past 18 years. I am losing a little ground but without these meds Id be in such far worst shape.

        Id give it a shot on the 82f. Sheds went from 12 to 20 hairs in shower to 2 or 6.

  12. Somehow we already have a cure… the BIG 3:)
    Something better will only come out in 10 years… I just feel silly to say 5 years… Lol

    PS. I feel sorry for all the guys who are so afraid to use finasteride… I’ve been using it for over 15 years and never had any problems with it… it’s all mental…

  13. Live your life, what is their new formula. My boy is asking…he has it with tretinoin, finasteride and minoxidil. Can you share the new formula details so I can pass it to him. I may order it too. I’ll call up your doctor in Texas. Should my friend call up the masterphsrm or phsrmD to get the new formula. He said his current 82f stopped working and that Crystal’s form in the bottles after 10 days

    1. Mjone, it has those three plus flucinolone .01. The formula has crystalizing issues so they went to this formulation. its the inactive ingredients that were changed as to help with the issue. i notice this takes longer to dry and is a tad on the oily side, but after 30 to 45 mins is fine.

      dr lam is a very bright guy, top of his class at princeton. seems to showcase nice HT results as well, however at this point I am only trusting him with his scientific knowledge vrs surgical skills. two widely different components. hard frankly to find both, which is why i have about 3 MDs that I talk with regularly here in the US.

      Barusco, Lam, Cooley are my three “go to” guys.

      I also spoke with Williams, Diep, Epstein and Arocha in the past year for opinions and consults.

  14. Live your life, thanks for the info I’ll let my friend know. He bought a new batch back in december. One of his bottles crystalized. Did the formula change for Jan?

    I noticed that you have been on propecia for 18 yrs like me. Crazy how long it’s been right haha. It worked great for me until about 2013 around 11th year. My hair started losing ground and scalp burning inflammation kicked in. That’s when I started using rogaine foam which help slow things down but I went from nw 1.5 2012 to nw 2.5 but diffuse. Need a blow dryer to give illusion of thick hair nw 1.5. I’m still receding and losing ground. Hopefully 82f can kick start some regrowth.

    What nw were you when you started fin? When did you add minoxidil?

    1. Mjone, i was NW 1.5 at age 23 when i started. no signs of balding, but wanted to be proactive and get in front of my genetics. im a difusse thinner and noticed 18 months ago i was progressing past NW 2 and thinning over top of scalp. added lllt and stem cell/prp. one year ago. added minox 6 months ago.

      when i add i decided to stay only on that addition to ensure i know what works and what doesnt.

      my final pattern could be a NW5 as there is 15% miniatarurized hair on scalp.

      but seeing some improvement in past year so grateful for that at age 41.

  15. Good stuff .live your life. Looks like we have similar hair loss. I miss the days of just popping a propecia pill and forgetting hair loss. Looks like propecia can’t fight off the progression once we hit our mid to late 30s. I’m glad we had propecia or else I’d be a nw7 at 28. What did the ht docs say about getting a ht when you are diffuse ? Did they mention shock loss?

  16. mjones, yeah i am grateful for fin and would be in greater trouble had I not started so early. interesting some docs like arocha and epstein felt they could use small punches and do 1500ish grafts with minimal risk of permanent shock loss. yet williams, barusco and cooley felt the benefit did not justify the risk. minor hairline work of 1200 to 1500 grafts was discussed, but again best to wait at this time.

    diffuse loss as you know is a slippery slope, almost need to experience significant loss before one can rebuild. the best approach is to establish a “forever” hairstyle and use that in your duscussion for HT. where will you part it, will you comb back, how to you wish to address crown.

    for me i find i will accept a bit of a higher forehead and grow into my 40s, 50s and 60s with a level of acceptance. my goal now is not to be 41 and get the hair i had at 30. but to make it to 50 with the hair i have at 40.

    in those 10 years I am confident in some surgical advances and treatments that will provide the rest of what we need to get us through to the finish line.

    frankly, i see being able to create large amount of hair for traditional transplant techniques as our most realistic “cure”.

    i foresee a day when a clinic can produce 1000s of grafts for your day of surgery by creating as Angela C has said a “hair farm”. This will essentially eliminate scarring and supply issues for a large majority of patients.

  17. Live your life…excellent post. Yes I was looking to fill in my first inch deep from my hairline back so just hairline with additional density, especially right side of hairline. A solid 1000 grafts would suffice but I’m afraid of shock loss making it worse. I would definitely still keep my hair style into my 40s and 50s. Its worked well to disguise my receding hairline. If I could just get 20% more density and stabilize I would be gold. Nw2 hair line and thicker overall density.

  18. It would be great to receive a press release/statement from one of the Tsuji related firms how they handle the situation in terms of possible delays in their trials. Their lack of external communication really makes me doubt their credibility more and more. It was bad even before the outbreak of corona but now it’s about time to hear something.

      1. breezula has also been delayed. they predict start of phase 3 in Q4 2020 or Q1 2021 now. such a blow i was really hoping for this one

  19. Admin:

    I need your input please. My current hair loss is NW 2.5, with severe diffuse thinning throughout. Will I benefit from hair cloning or other treatments coming out in the future? Will stem cell therapy reverse all the diffused hair? How about hair cloning, will my diffuse thinning prevent me from getting my hair loss corrected?

    Thank you.

    1. Alexander hop on propecia , nizoral asap! Save what you have! Dont rely on future treatments, they may never arrive. Propecia may grow back some hair too. You can add minox later once propecia stabilizes your loss.

        1. I have the same thing as you, started developing hair loss on the sides, back, body, eyelash, eyebrow. I remember having enlarged lymph nodes since the start. I think I have alopecia aerate. Gonna get it tested. Doc said I need a biopsy. You should do the same

  20. Yo I will say this, I’ve had hair loss for like 10 years now. Held onto most of my hair. In September I switched from foam to liquid minoxidil. Lost like Half my hair. I developed an infection on the back of my head in march from the minoxidil and started losing hair there. I think I’m allergic to the liquid Kirkland brand. Switched back to foam last week and everything is clear. Its really weird. Went from losing 80 hairs a day to like 15-20.

  21. Just throwing a micro grain of optimism out there, if your looking for one………..Follica is no doubt limping toward initiating their Phase 3 trial with their disclosure last week of positive FDA feedback, and now an update on the Puretech time line showing Phase 3 ready: https://puretechhealth.com/product-candidates/details/follica
    Also, it is somewhat intriguing that Phase 3 will include a maximal use study (conducted to assess the bio-availability of topical drug products intended for local therapeutic effects), possibly indicating the treatment includes a compound other than minoxidil. You would have to think that maximal use studies would have been conducted long ago on minoxidil unless they are re-assessing bio-availability in conjunction with micro-needling.

  22. Any idea why Follicum is developing a cream instead of a solution or foam? How can someone who still has a decent amount of hair left spread a cream evenly around their scalp?

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