Category Archives: FOL-005

FOL-005, Follicum

Follicum Latest Summary

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I have covered Swedish company Follicum a number of times in the past on this blog, with my first post about them going back almost three years. You can click on the company name that is right above the title of this post to read all my past posts about Follicum.

The company is 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.

Follicum 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:

  1. Powder formulation – FOL-005 in emulsion of lipid-based suspension.
  2. Cream – nanoparticles of FOL-005 in lipid-based suspension.
  3. Gel – FOL-005 incorporated in polymer nanoparticles.

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.

FOL-005, Follicum, Osteopontin

Follicum Phase I/IIa Results

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I first covered Swedish company Follicum and its FOL-005 hair growth product exactly two years ago. I wrote another post on the company early last year. Thereafter, I have only covered them in passing as part of my once a month “brief items of interest” posts.

Most recent developments were minor and related to country specific patents and so forth. My main reasons for following this company are due to the facts that they are conducting their research at the prestigious Charité Hospital in Berlin, Germany; they have an impressive group of hair loss related scientific advisers; and they have been providing us regular news updates.

Follicum 2016 Annual Report

Earlier today, a person by the name of “Rickard” e-mailed me and asked me to check out Follicum’s latest report. When I then went to Follicum’s website, the news section had not been updated since last year, while the press release section had several updates from last week, one of which was the release of their annual 2016 report. It is in Swedish, but can be downloaded and then translated via “Google Translate”. I learnt some interesting new things in the report:

  • Follicum was founded in 2011 based on research from Lund University by Anna Hultgårdh Nilsson and Pontus Dunér.
  • The company’s technology entails isolating the protein osteopontin, which regulate hair growth.
  • “FOL-005 is a section of the protein, gathered in a small molecule (peptide) where two amino acids are deleted and replaced by a third”.

Follicum Timeline

  • Company inception (2011).
  • Preliminary study on live mice (2012).
  • Study on human skin in vitro (2013).
  • Study on human skin transplanted to mice (2015).
  • Toxicity study for three months (2016).
  • Clinical Phase I study of subjects (implemented 2016-2017).
  • Clinical Phase IIa study – a limited effect on the study subjects in the phase I study (2017).

At first, I was not sure about writing a new post on Follicum just because of the above annual report. However, thanks to commentator “Hopeful” posting this new link, I realized that this was probably what “Rickard” was talking about earlier.

Clinical Study Shows 8 Percent Hair Growth

After translating this new link, it seems like Follicum’s FOL-005 resulted in an 8 percent increase in hair growth in patients treated at the Charité Hospital in Berlin in phase I/IIa clinical trials. CEO Jan Allenfal states that this compares favorably to existing treatments that results in a 4-14 percent average increase in hair count. With further testing and experimentation of dosage and composition, FOL-005 is likely to results in even superior results.

I think its great to get a third option to the two main current treatment options (Finasteride and Minoxidil). Even something new that only maintains existing hair would be very welcome (especially for those such as myself who are not keen to reduce their DHT levels for many years continuously via taking Finasteride).

However, will FOL-005 grow back hair in those who are already severely bald? Not likely.