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.
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:
- 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.
- Hamburg-based proDERM, which just celebrated its 25-year anniversary. The have an interesting website section on hair care and hair removal.
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.
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