Follicum Phase IIa Trials Back on Track in Germany

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.

Hair-Bearing Skin Generated from Pluripotent Stem Cells

Blog readers keep giving me breaking news faster than Google Alerts, and I am appreciative. This time, thanks to “Del”, even if his input has forced me to write two posts in one day. Update: The podcast for this news is here.

Pluripotent Stem Cells and Hair Growth

Yesterday a very important study was published in Nature Magazine. It is titled “Hair-bearing human skin generated entirely from pluripotent stem cells”. The scientists behind this research took 6 years to complete and publish their work.

The study has numerous co-authors from a few medical centers and universities based in the US. The lead author is Dr. Jiyoon Lee, while the correspondence author is Dr. Karl Koehler. The latter works at Boston Children’s Hospital as well as Harvard Medical School. Moreover, Dr. Koehler’s lab has its own site, on which he published a post about these findings.

Dr. Karl Koehler via Twitter

Pluripotent Stem Cells to Grow Hair
Pluripotent Stem Cells to Grow Hair. From Dr. Karl Koehler’s Twitter feed.

From Skin Organoids to Hair

In this latest research, undifferentiated human stem cells were successfully coaxed into developing skin-like organoids in vitro. When these human-derived structures were grafted onto immuno-compromised bald mice, the rodents produced robust (albeit shorter length) hair.

Note that in 2015, Dr. Alexey Terskikh and his team used pluripotent stem cells from humans to create dermal papilla type cells. These were then injected into hairless mice and grew hair.

Pluripotent Stem Cells Hair Growth
Pluripotent Stem Cells and Hair Growth — Nature Magazine.

In this new work, the scientists generated near-complete skin organoids first that ultimately resulted in pigmented hair. The skin cells grew in a sphere and were “fed” with various chemicals and growth factors (such as BMP4 and FGF2) for 4-5 months. Both the dermis and epidermis skin layers were grown successfully.

If this work goes through successful clinical trials, it will essentially mean a cure for hair loss. Nevertheless, the global media has largely ignored this research, with the UK’s Mirror being a notable exception. And as always, the Daily Mail too.

Cotsarelis Rises Again

Prolific blog commentator “MJones”‘ favorite hair loss researcher and fellow Alexander the Great progeny Dr. George Cotsarelis has been missing in action of late. However, this new research is so significant, that Dr. Cotsarelis and Dr. Leo Wang wrote a detailed article summarizing it in Nature Magazine.

Per the two doctors, this study represents a major step towards a cure for baldness in humans. They are confident that this research will eventually see its promise realized. This technique makes it possible to produce human hair without having to take any donor hair from the human.

Moreover, individuals who have major wounds, scars and genetic skin diseases will all benefit from revolutionary new treatments based on this research. That is if it comes to clinic of course.

In these times of pandemics, protests and riots, it is great to see Dr. Cotsarelis’ still unabated optimism. Ironically, for “MJones”, the glass has always been half empty.

Further reading: An excellent 2019 paper summarizing tissue engineering strategies for human hair follicle regeneration.

Hair loss cure news blog. Hair cloning and multiplication for baldness. The latest news in hair regeneration.