Follicum Shares Results From Phase 2a Trial Of Topical FOL-005
On May 6, 2021 the Swedish biotech company Follicum announced results from its pivotal phase 2 trial which represented the first time its candidate peptide FOL-005 was tested topically to treat male pattern baldness.
FOL-005 Grew Hair, But Not Quite Enough
To keep things succinct, FOL-005 did not reach its goal in the phase 2 trial. In the group of participants who received the highest dose of FOL-005, an increase of 6.6 hairs per cm² was observed which is statistically significant, however, the placebo group also noted an increase of 5.6 hairs per cm² which means there was not a statistically significant increase compared to placebo. Thus, Follicum will be dropping its program for androgenic alopecia, but still possibly pursuing FOL-005 for other indications.
Here’s a quote from Follicum’s new CEO Kim Arvid Nielsen in their latest press release, “Compared to the results achieved in previous preclinical and clinical studies of FOL-005, the outcome of the Phase IIa study is disappointing. However, our confidence in the concept of tissue repair peptides remains high and we will now carefully analyze the results to draw conclusions on how we can optimize the development plans for FOL-005 and the company’s other projects.” Kudos to Follicum for being up front about their results and also for developing this drug over the last 5 years for hair growth. Surely, most of us are a bit disappointed too, yet, in a large field of players it is understandable that some candidates will not make it to the finish line.
Incidentally, our Ultimate Guide to Hair Regeneration pipeline was updated this week (and now will be due for another update per this news). Feel free to have a look and know that all hope is not lost, we have many other contenders currently moving forward in the hair game.
Take care Follicum, it’s been real.
Posted in Follicum
Well, I know it’s not the news we wanted, but it’s the news we got. Now, we look to other emerging companies in this race. One of my current favorite companies already into phase 2 testing is Kintor Pharmaceutical, which are your guys’ favorites now?
My current favorite is Kintor too, might be a bit too late for me as I would need it now but it’s very promising. Similar to finasteride with less side effects is pretty perfect for all young people out there. They work fast, they got cash (1.5bn valuation) and they seem determined.
I have hope in general that one researcher stumbles upon a new compound for us as it happened with minoxidil and finasteride. With all the clinical studies being done, the technical advancements in diagnostics, sequencing, data analytics and AI it’s just a matter of time until we have a full head of hair again.
Thank you for the update admin.Its always sad to see a potential treatment failing at the final stages.
Respect to these guys, Unlike Tsuji who won’t just be honest with his failure.
FDA Grants RenovaCare Full IDE Approval for Safety and Feasibility Clinical Trial
Does it have anything to do with hair?
Yes, not the news we wanted to hear, had hopes for Follicum.
Good luck to them on their future ventures.
If Samumed phase 3 is also disappointed, we will get another decade of no new real/affordable treatment. What a nightmare….
Not good news for sure but thanks for reporting Admin. Don’t get too vested in anyone product that’s in the pipeline. As Belushi said in Animal House, “it ain’t over till it’s over” no matter what “progress” companies report in the meantime. Being in actual human clinical trials is a good sign but not a guarantee.
Yoda that’s a good movie.
Yes it is Woofy my boy…the phrase in that posting that I want you to focus on specifically is “Don’t get too vested in anyone product that’s in the pipeline.” You are the poster boy for being so enthralled with Tsjui, good to have asperations but not blind allegiance. A guy that’s lost his financial backing, is begging for money on the street, that’s only done clinical testing on mice and is now promoting cosmetic tonics isn’t something to put all one’s hopes in.
Here we go again… I’m not the poster boy, I’m a guy who is a higher NW then you and wants a cure. I’m getting annoyed it’s every time I comment about them. I don’t care, and today I’m talking about stemson because I heard the pig news. But Tsuji and stemson and crispr moongene are our only options if we want a cure.
Fair enough. Yoda, please stop agitating Woofy (I realize it may not be totally intentional). If he wants to be psyched on Tsuji, Stemson, Doge coin, it’s his prerogative and we respect that here ?.
Shouldn’t Triple Hair be on in the Ultimate guide? Hoping for their topical fin/minox product by 2023
Hi John, Triple Hair is not quite in human trials yet. When they schedule a trial they will get on the Guide for sure.
It’s tough love, I like Woofy, just wish he would investigate what else is out there besides fin and Rogaine to help his current situation. Fair enough, I’ll lump him in with posters over the years from other sites that were psyched on various treatments (“NasaRS” on JAK, “It’s 2014” on Bim, etc.). For the record, Doge Coin is the only thing mentioned that has shown real performance to date.
I remember reading about Histogen and Replicel in 2014 and telling some fellow hair loss buddies we were a couple years away. I’d follow the news and maintained my hope delay after delay. How’d that work out? While I haven’t written either off (they are still in the game, right) I learned not to believe everything you read from companies and researchers, they have an agenda and sometimes “put lipstick on a pig”. Doesn’t mean they are pushing snake oil, will never come out or are in it for a “cash grab”. But they do have to keep the money spigot flowing, putting the best spin helps in this endeavor.
I understand Yoda, it just comes back to a principle, we can only really control our own decisions, can’t do it for others. Offering to help is a noble cause, and even then it’s up to others to be receptive to the offer or not. The way of the Jedi 😉 Moving on, thanks again for your continued support of FT and with grace and luck we can hopefully soon enough start talking about one of these new treatments that changes the landscape for us.
PS. I hope you got in early on Doge!
Yoda isn’t a crypto guy, too much for my old brain to absorb. I’m with Buffet on it, maybe won’t have the big score but can sleep well at night knowing my dough is in boring equities and bond funds.
Not in crypto myself either. I like the practical approach you mentioned.
What about Follica, CB, Samumed and triple hair? They are in the final phase, am i right?
No one here have some hopes on them?
Yes, I have hopes on those D. They are actually in late stage clinical trials. Doesn’t guarantee they will come to fruition nor be holy grails but they are the closest, next gen treatments we can hope for.
1.Follica doesn’t seem promising so far. Microneedling + Minox, but it is not yet known (I think) which other substances are included? Nevertheless, it doesn’t look particularly revolutionary so far and uses already known (minox) treatments. Also, I don’t expect the costs to be particularly affordable just because of the doctor’s sessions.
2. The same applies to triple hair. The first treatment only includes Minox and Fin as topical. The natural product, on the other hand, has already been tested by many without any positive results.
3. Breezula seems to be taking a long time. Stage 3 is a long time coming. With bad luck, Kintor will overtake them. We do not need to expect a market launch before 2023/2024 and here, too, the question remains whether it is worth it. the price of $ 100-150 per month has already been confirmed ….
4. So far, SM has not been very popular in the community as the results were “sobering”. “Only” 10% growth. Here, too, doubts remain, as phase 3 has long been completed and yet has not been specifically announced. The CEO also said that they would concentrate on their other treatments. Unfortunately, I’m currently assuming that the results will be similar to Fol005. I would have liked it differently, but unfortunately it is not looking good so far. So we stay with Minox and Fin. And even if Tripel Hair and Fol 004 are successful … they also bring “nothing new” but already existing …
A slight correction to your point Deveil. Triple Hair’s pharma product is a combo of finasteride, minoxidil, and latanporost, hence the name Triple Hair. This combination is possible in today’s market but the 3 ingredients have scarcely been professionally compounded into a formula like Triple Hair’s TH07.
I’d ad that much of Deveil’s conjecture is based on anecdotal opinions from hair loss website participants. We won’t know the outcomes of the trials until they are actually completed. Not that Deveil stated this firmly but I want to see direct statements from Follica that their treatment is comprised of off the shelf topical minoxidil and a roller with the same specs one can buy on Amazon. I’m waiting…
I had no hope in Follicum, nor in samumed and follica. but it would be nice to see them on the market. admin, what do you think about this ?https://www.asiaone.com/business/hope-medicine-completed-us56-million-series-b-financing-strengthening-capabilities-global?amp
Hey, looks good Soul, where the money flows there is typically good science (and reason for the money to flow that way). Some companies are really getting big investments to develop their drugs and start trials. This is awesome.
Time and time again history repeats itself in the world of hair loss. Each treatments fails, delays or disappoints. At least follicum has the professionalism to straight up say it failed and stop the project. I respect for not being snake oil company. I say let’s be hopeful but I stopped being hopeful in this industry. All we have now is samumed, follica and that kintor CB but none of those really grow robust hair regrowth. Msybe maintenance for a couple years.
Any news from bayer or is that getting shelved?
Mjones, read the post above you and you’ll find the answers you are looking for. HopeMed is still active, secured a 53m series-B funding and they will start phase 2 soon.
He was talking about HopeMed instead of Stemore. https://www.thepharmaletter.com/in-brief/brief-hope-medicine-inks-global-license-with-with-bayer But lately there is no news about progress.
@Admin yes I think I understood Mjones correctly and there is news, check the link from Soul:
https://www.asiaone.com/business/hope-medicine-completed-us56-million-series-b-financing-strengthening-capabilities-global?amp
This is about HopeMed which signed the license agreement with Bayer. I mean it doesn’t have exact dates but getting the funding and starting phase 2 “soon” is pretty huge.
I understand Maker you’re right, the link from Soul had not shown up for me because I had not refreshed my browser, all I could see was your link from earlier regarding Stemore. Now it’s clear. Cheers
I’m personally all-in on Kintor. Many of us need a safe anti-androgen that doesn’t alter the state of our reproductive organs, be that a temporary complication or not. I had high hopes for CB until seeing the price tag and safety profile on Wenlevi. On the other hand, by the time any of these treatments hit the market, I expect our options and understanding of this disease will have multiplied. I can’t see how making hair on bald scalps grow within the next 10 years is an impossible medical feat.
I’m all in on what ever actually hits the market next and shows improvement above what’s currently available. Other than that I’m not a fan of one treatment over another.
How comes HMI-115 isn’t in the pipeline? It’s completed phase 1 and they announced its ready for phase 2 the other day.
https://us.acrofan.com/detail.php?number=464424
https://www.dealstreetasia.com/stories/hope-yikon-fundraising-239664/
Olix and CK biotech are also done with preclinical and preparing for phase 1, I think.
thinning, I’m not sure whether that phase 1 study was for hair loss or not. Either way, when they get their phase 2 going for hair they will surely be in the pipeline. Companies on the list either have something with extraordinary potential or have begun a clinical trial typically.
Phase 1 doesn’t need to be for hair-loss specfically, it just needs to show safety providing its the same dose and treatment that will be in a phase 2 for AGA.
Phase 2 for AGA/Endo are going off the back of that study, it states this in the press release IIRC.
Understand why you’d only want extraordinary potential on there, but Olix most definitely falls into that category. They’re a great company and developing an AR siRNA, which I’m personally more excited for than the AR Protac from kintor (which is still a massive step forward from what we have available today).
Also only realised a ton of other people mentioned the HMI press release to you, my bad!
@thinningontop , i have a question, blocking prolactin systemically won’t cause any side effects?
Theres the potential for that of course, we won’t get any real idea until phase 2 though. I could speculate, but it would be pointless.
Some people are currently using an alternative treatment, a patent for a novel small molecule inhibitor of PRLR was identified, group buy got a lab to synth it and people have been using it alongside RU, Min and KY. Some just using as a mokotheraphy as well iirc.
I personally think that Follica is coming with a better option that what we have at the moment (that’s what the pics they posted looks like),
and still don’t know why Ru is not on the market or at least being on trials…
From what I understand with RU the company developing it was sold and with the time lag the patent ran out. RU had some positive effect on me, however I was on oral dut as well. Not sure how well it’d do on its own. I gave up RU once I got my hands on topical dut 0.1% in my 7% minox and didn’t miss it. Now am weaning myself off oral dut with 0.5% topical dut in it’s place. So far, so good. One thing about dut vs. fin, dut is dose dependent. The studies showed increased effectiveness for hair loss/growth for 2.5% vs .5% oral. Can’t say this is the case for topical with 100% certainty but you’d think it would follow the same as oral.
Hi admin,
Is exicure doing a joint research with allergan to find the target for their gene therapy?
Yes, they are.
Disappointing but I give them full credit for doing the right thing and being open and communicative, and willing to admit when things didn’t go as planned. Kudos to them o wish them all the best.
As for the future, the only real hope I have left is for kintor. I fully believe their product will be released before breezula, and I hope it’s soon. Finasteride has sadly only been able to slow my hairloss but not stop it, so I’d love another option.
Thanks to the admin of this site for the hardwork as always
Steve, you might look into oral or topical Dut if you’ve given fin enough time. I’m leaning towards the topical route (dut not fin). Maybe stay on the oral fin and try topical Dut, just a suggestion.
What is the stemson pig trial? I can’t see anything online about that?
Thanks
Woz https://vimeo.com/493480668 go to Around 32:40min. A person at fortunis says they finished the pig trial. That’s the news
With the permission of the administrator I will leave this post waiting for everyone’s opinion, I understand that this Doctor is a collaborator of hairclone in the USA
https://californiahairsurgeon.com/news/technology-used-in-covid-vaccine-can-also-help-with-hair-loss/
Man, Yoda is not all that bright but trying dubious exosome therapy to the same technology and Pfizer and Moderna mRNA vaccines seems like a stretch. Seems like the good Dr. Wasserbauer is weaving a tapestry out of many fragments that may not be a lie, however she may be spinning straw into gold.
My overall sentiment of most (not all) hair restoration docs is they are marketing machines that will push the envelope to get patients in the door in a more and more competitive market. Either for the dicey treatment at hand, an upsell to a transplant or both!
Any more scientifically educated posters care to comment?
Thanks yoda correct answer
Thanks for posting that Gooz, always good to see what these guys are up to with their “revolutionary” treatments. I just checked out the website of the doc I had 4 PRP/CRP sessions with (little to no results). He’s still big on exosomes with no more proof that they do anything since the year that I last checked his site. Buyer beware!
I was never hopeful about Triple Hair, but I now have more reason to doubt them. Their natural product (never interested in that) was supposed to be released in May (said so just a couple weeks ago on their website). Now it just says “2021.” But it gets better! Their pharmaceutical product went from projected Q3 2021 Phase III trial on their website just a few weeks ago to now just a 2022 projected Phase III start. Wow – that some serious timeline pushback. Don’t hold your breath, folks. Reminds me of Breezula now. Bad year so far for hairloss news.
Felix, delays don’t necessarily = defeat. This stuff never happens as quick as we all would like. I’m not a triple hair fan or foe, just stating a fact.
Hello Yoda…I understand that your new focus is on topical treatments. Does that also include your oral minoxidil?
I finally managed to obtain Loniten. I am on 5mg now. Obviously I monitor BP.
I am pretty certain that I can obtain it permanently. Alternatively I could obtain it in Thailand when on my annual trip to NZ. I used Rogaine 30 years ago..horror.
I read that some people drink minoxidil. For instance 0.2ml mixed with vodka.
There was also talk about sublingual administration.
However that appears to negate the benefit of oral minoxidil as it bypasses the liver. The liver function ensures that everybody becomes a responder.
Regarding triple hair, TH16 appears to be a nice addition. But without anti androgen and minoxidil I feel that efficacy may be only marginal..if at all.
What do you think?
Hi MRKA, My switch to topical dut (if I don’t loose ground) will not affect my use of oral minoxidil. I had too much positive results from oral minox to give it up. I still use topical minox (with other additives)as well and plan to continue that as well. You should be consulting with a doctor on your use with oral minox. If I were you I’d start out with 2.5 mg and see how it goes, only bump up to 5mg if needed. I’m on 10mg but have boarder line high BP. I did experience some mild fluid retention at 5mg, at 10mg I need to take a diuretic, all under a dr’s supervision.
I have no feelings on Triple hair, in a wait and see mode.
Hey Yoda, just though I’d share this as your somewhat on the same treatment as me.
I use topical dut and RU, for me its produced the best result using both.
Probably due to RU cleaning up the excess T production which is a result of blocking DHT production. Also get the added benefit of a bump in aromatisation of T into E.
I myself don’t like using RU due to it not having a safety profile, but until Kintors treatments (hopefully) come to fruition.
Atraric Acid is a cheap alternative, although theres no evidence of its efficacy in AGA (due to lack of studies) and its binding affinity to the AR is most likely weak compared to RU, which means you’ll have to use higher concentration.
All the best
Correction:
Probably due to RU cleaning up the excess T which is a result of blocking DHT production. Also get the added benefit of a bump in aromatisation of T into E.
Also, shout out to who ever mentioned exicure. Been waiting for them announce targets for ages lol… oligonucleotide nanotechnology? yes please
Hi Thinning, I agree with everything you wrote. Yoda saw better results when adding RU to oral dut than oral dut alone. However, my intial use of topical dut (.1% in 7% minox) and adding oral minox had me stop the RU as I don’t like to idea that it’s unregulated. I haven’t lost any ground that I’m aware of, possibly if I was still on RU my gains might be better, but I’m fine with where I’m at presently. Plus multiple topicals is a pain, I’ve been attempting to simplify my regime.
Finding a target is the hard part, involvement of multiple genes makes it very difficult to find a target.Their nano delivery technology is already proven.The easiest target is to go for the OliX route?,but i think more research should be done to find the exact genes.
Thanks Yoda,
Sure, all prescription medicines are taken under medical supervision. Its a fundamental rule for me and everybody should do it.
I am one month into oral minox. I have not observed anything yet. Perhaps a small shed and dark circles under the eyes. But it could be all pure imagination as I focus on these things now.
My specific question actually was regarding oral administration of 0.1ml liquid minoxidil. It works out as 5mg (5% minox). I could imagine that it is difficult for many people to get a prescription for Loniten. And as I understand it, the majority of people are non-responders to topical minox unless they microneedle. So it could be beneficial for many on here.
Regarding TH16, I consider this as an additional treatment with perhaps marginal benefits.
MRKA, I can’t speak to drinking topical minox. Yoda has poured a lot of shots of alcoholic beverages down is gullet over the years but this seems far fetched to me. That’s an uneducated opinion.
[…] results in its phase 2a trial for its topical peptide FOL-005 in AGA. The press release shared on May 6, 2021 stated that the highest dosing group showed a significant increase in hair growth over its baseline […]