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.”

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.

I have covered Swedish company Follicum numerous times on this blog in the past, including twice earlier this year. The company is developing a topical scalp hair stimulation product called FOL-005 that is based on the human protein osteopontin. Interestingly, a variation of this same drug will likely be developed by Follicum in order to reduce body hair. Definitely read my post on excessive body hair in men and its correlation with scalp hair loss.

Of the numerous companies in the world that are developing a treatment or cure for hair loss, Follicum is currently the most professional when it comes to its communications and its product development strategy. Their clinical trial time-frames for each stage have generally been accurate over the past few years. And they seem to be on schedule to continue to hit targets over the next year.

Follicum Topical Formulation Milestone

Earlier today, I got an e-mail from Follicum notifying me of their achieving a major milestone. The company has now successfully developed a direct-to-scalp topical formulation for their FOL-005 hair stimulation drug. This will in the near future replace their current method of delivery (intradermal injections) of FOL-005.

This new proprietary topical formulation is a non-running gel, making it easy to apply. The formulation remains stable for several years at room temperature storage. Moreover, the formulation is designed to ensure good skin penetration and distribution in both the epidermis and the hair follicles.

According to CEO Jan Alenfall, Follicum’s extensive experience in developing peptide drugs has enabled the company to develop a stable formulation that delivers FOL-005 directly to the hair follicle.

Company Advisory Board

While browsing through Follicum’s website today, I also noticed that their scientific advisory board page seems to have been updated recently. They now have a highly respectable and accomplished group of advisers, many of whom have been covered on this blog in the past. The most well known of these in the hair loss world are Dr. Gerd Lindner (Germany), Dr. Ralf Paus (UK/Germany), Dr Ulrike Blume-Peytavi (Germany) and Dr. Amos Golhar (Israel).

If all continues to go well in Phase II trials, it is not out of the question that Follicum’s hair growth product could be released around the end of 2020. However, this is not going to be a hair loss cure. Just a new hair loss treatment with no major side effects.