Category Archives: FOL-005

Coegin Pharma to Release FOL005 Gel in 2025

I covered Follicum (Sweden) and its FOL-005 (now FOL005) hair growth peptide in eight posts between 2015 and 2021. Prior to the company’s cessation of work on FOL005 and a 2022 acquisition by Coegin Pharma (Sweden).

Follicum’s unique osteopontin based hair loss treatment is very interesting. Their product can both stimulate scalp hair growth and reduce excessive body hair growth (hirsutism). And the same technology could potentially treat diabetes and inflammation related problems.

Follicum’s frequent press releases, CEO Jan Alenfall’s presentations, and the company’s rapid clinical trial progression impressed me. Their chief business officer Gunnar Gårdemyr was also in regular communication with me.

October 25, 2023

Coegin to Release FOL005 Hair Growth Peptide Gel in 2025

Some major new updates since I wrote the summary earlier this year (see second half of this post).

“After carefully analyzing the possibility of launching FOL005 as a cosmetic product line, we have come to the conclusion that it is an opportunity with great potential. This will minimize development risk, significantly reduce capital requirements and strengthen commercial opportunities in the short and long term. We have therefore revised our strategy and now aim to launch FOL005 as a cosmetic product series as early as 2025 with the USA as the first market.”

It seems like CosmeRNA started a great new trend. No more ten year clinical trials and failure to come to market!

  • Follicum’s website seems to have been restored and updated very recently. The milestone plan page has a detailed chart for FOL005:
Coegin Pharma FOL005 (Follicum).
Coegin Pharma FOL005 milestone timeline. Source: Follicum website.

April 8, 2023

Follicum Past Clinical Trials

I covered both of Follicum’s past clinical trial results in 2017 and 2021, respectively.

  • In 2017, Follicum’s Phase 1 clinical trial results were released. They were deemed as positive (8 percent increase in hair growth), with an effect comparable to that of Minoxidil. Moreover, safety was not an issue, with no major side effects in trial participants.
  • In 2021, Follicum’s Phase 2 clinical trials of FOL-005 came out. The topical compound resulted in a 6.6 hair/cm2 increase in hair growth, but this was deemed to be insignificant compared to placebo.

Thereafter, the company ceased further development of FOL-005, and it all seemed over for yet another false flag operation. Or perhaps not?

Merger and Acqusition by Coegin Pharma

In September 2021, Coegin Pharma merged with Follicum. This merger was confirmed as an acquisition in 2022.

In the first of the two links above, Coegin’s CEO Tore Duvold said something of interest in the interview:

Question: “With regard to the hair loss project, which has recently been put on hold, how will it be handled once the companies merge”?

Answer: “Follicum announced that they have paused the hair loss project. In Coegin, we have strong capabilities in dermatology, and we will review and analyze the results before we make any conclusions”.

Follicum Back in the News

  • In March, a Tweet from Coegin indicated that they were meeting with potential partners for Follicum’s FOL-005.
  • Follicum was mentioned in February in an updated article titled: “Could We See a New Dawn for Hair Loss Treatments?”. It summarizes the problems that the company faced in trying to bring FOL-005 to market after the unimpressive Phase 2 trial results.
  • When going through Coegin Pharma’s website, I found a highly detailed comprehensive corporate presentation on Follicum and FOL-005. It was presented at the end of 2022 by Coegin’s COO Kristian Lykke Fick.

Their take on the past trials is more positive. Key quote:

“FOL005 1.5% dose was on par with treatment effect reported for minoxidil and finasteride with a growth of 12 hairs/cm2 after 4 months of treatment. However, with more than 60% of subjects responding to treatment compared to competitors where 40% responders effect is previously documented after 4 months.”

Note that Follicum’s old Swedish website is being routed to the English site that has an expanded research section on FOL-005. In 2022, they also filed for a patent related to wound healing. I am surprised they do not mention anything in relation to their osteopontin-derived peptide’s body hair growth inhibition.

Follicum plans to conduct various new scalp hair growth related clinical trials from 2023-2027. On their website’s plans section, they state the following:

“We believe there is a high likelihood of success based on the previous clinical data.”

Too bad about the new time frame and the wait for venture partners for funding. Otherwise, I am not entirely pessimistic about this product. I do feel that it can compete with Finasteride and Minoxidil in terms of effectiveness, but via a totally different mechanism of action. And with no serious side effects.

Follicum Phase IIa Trial Results Disapppoint

Update: May 6, 2021

Disappointing Results from Follicum FOL-005 Phase 2 Trial

Follicum just released top-line results of their Phase IIa study of FOL-005 for the treatment of hair loss. The results are disappointing.

“In those treated with the highest dose of FOL-005 studied, hair growth increased by 6.6 hair/cm2, compared to 5.6 hair/cm2 in the placebo group.”

The difference between the treated group and the placebo group was not significant. While I never expecting this treatment to be anything much better than Minoxidil, I was still hopeful. Follicum has been extremely professional and fast in its trial progression and updates since I first started covering them in 2015.

In any case, it is also rare for a company in the hair loss world to give us disappointing news in an honest manner. A number of other hair loss companies in the past (and present?) tend to extend their importance beyond a decade. Then they ultimately fold or go out of business.

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.

Follicum Trials to Restart

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.

“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.”

Follicum FOL-005

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.