I have covered Swedish company Follicum a number of times in the past on this blog, with my first post about the company going back almost three years. You can click on the company name (or product name) that is right above the title of this post to read all my past posts about Follicum. They are working on an interesting modified human protein based product called FOL-005, which can both reduce hair growth (great for those with excessive body hair) and increase hair growth (great for those with less scalp hair).
After I published the recent news about Follicum’s phase 2 trials in my last post, a representative from the company reached out to me several days ago and provided the excellent below summary of where the company currently stands:
FOL-005 for stimulation of hair growth
Follicum has, in collaboration with international R & D partners e.g. Charité Hospital, Berlin, Germany, evaluated FOL-005 (a peptide) in different models for regulation of hair growth – both in-vitro and on humans. Our development process may briefly be described as follows:
- Trials on mice (2012).
- Trials on human tissue in-vitro (2013).
- Trials on human tissue transplanted on mice (2015).
- Toxicity trials, three months (2016).
- Clinical phase I/IIa trial on humans (2016/2017).
- Development of a topical formulation for FOL-005 (2017/2018).
- Beginning of 2018 Follicum will start a clinical trial (phase IIa) in Alopecia on scalp. This time including 60 alopecia patients. The study will read out during end 2018.
Preparing for further clinical trials of FOL-005, Follicum conducted two separate three month toxicity trials during 2016. Both trials showed FOL-005 to be safe for further administration.
During the period from late 2016 to early 2017 the first clinical trial was carried out on healthy humans at the Charité Hospital of Berlin. The main objective of the trial was to confirm the safety of the drug, FOL-005, and to measure effect and response. The results showed, first of all, that the treatment was safe while also showing a considerable increase in hair growth. In all, 76% of the trial participants with the second lowest dose of FOL-005 during the trial showed increased growth. At this specific dose, the growth was stimulated roughly 8% compared to before treatment. The increase is statistically verified (p=0,0038). Please note that this was a short 3 month trial on thigh and that the next study will be on 60 Alopecia patients on scalp.
We are in parallel with the clinical program developing three different topical formulations from which we will select the one that is most attractive during Spring 2018 to be used in phase IIb clinical trials 2019. The prototype formulations are the following:
- Powder formulation – FOL-005 in emulsion of lipid-based suspension.
- Cream – nanoparticles of FOL-005 in lipid-based suspension.
- Gel – FOL-005 incorporated in polymer nanoparticles.
Their year-end summary is here. Note that the company’s CEO Dr. Jan Alenfall has a number of mostly Swedish videos on youtube (although with English presentation slides in some). One useful recent one is here.