Category Archives: FOL-005

Follicum Phase IIa Trial Results Disapppoint

Update: May 6, 2021 — 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 cased, 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.

A Truly Outstanding Week in Hair

As if my last post on Dr. Terskikh’s progress and new company was not enough, three other new developments occurred last week that were extremely encouraging.

Follicum Positive Phase IIa Results

“The clear effect we saw in the growth phase supports the hypothesis that FOL-005 can “awaken” dormant hair follicles.”

I have mentioned Sweden-based Follicum numerous times in the past (see all Follicum past posts). Of the 50 plus companies that I have covered on this blog in the past five years, Follicum has been the most professional in my opinion (at least when it comes to companies based in the western world).

This week, the company announced Phase IIa trial results.

Also, CEO Jan Alenfall gave a much more detailed interview discussing these results.

The quote that I posted above in red is the best part of these results. So now we have yet more evidence that long-lost miniaturized “dead” hair can be reawakened.

There are some issues regarding appropriate dosage levels. Follicum plans to test higher dosages in the next phase of trials. In these Phase IIa results, the highest dose resulted in an 11% median increase in the number of hair follicles in growth phase.

Maintenance of existing hair and an 11% increase in new hair would be amazing considering that this FOL-005 product did not cause any side effects (all too common with Finasteride and Dutasteride). Here’s to hoping for even better results with higher doses.

Samumed Initates Phase 3 Trials

In its latest monthly newsletter, Samumed announced that:

Samumed Phase 3 Trials

Not a big surprise considering my August 2018 post on Samumed’s pending Phase 3 trials. Wonder in which country they are holding these trials?

Dr. Takashi Tsuji Still Aiming for 2020

Thanks to “Winston” for finding this Japanese government website link update on Dr. Takashi Tsuji’s work. The doctor is partnering with Kyocera, RIKEN and Organ Technologies, so those companies also need to be mentioned. Key quote:

“Regenerating hair follicles is the beginning of that road, and after preclinical and safety testing, our goal is to implement it by 2020. Starting by curing baldness, our intention is to develop an industry aimed at improving quality of life.”

I would want nothing more than an end to baldness and a cessation of my writing these posts after December 31st, 2020. Dr. Tsuji is my number 1 hope of making this happen. He has the requisite intelligence, ethics, drive, decades of research experience, corporate funding and government support.

Addendum: A few people posted comments or e-mailed me about new UK-based hair regeneration company btechlaboratories (since Fuji Maru from Japan covered this company recently). However, btechlabs currently has an insecure (non-https://) website with bad quality writing and layout. And their Twitter link goes to a host provider’s Twitter account. I would expect my readers to be a bit less gullible.