Follicum Phase I/IIa Results

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.

Decernotinib

I have covered janus kinase inhibitors (JAK) in numerous posts on this blog in the past. They were by far the biggest news story in the hair loss world in 2014 due to several groundbreaking studies that showed that using oral JAK inhibitors ruxolitinib or tocafitinib cured alopecia areata (AA), psoriasis and vitiligo in many patients. However, less than 5 percent of hair loss sufferers have alopecia areata (an autoimmune disease), with the vast majority having androgenetic alopecia (AGA) instead.

At the time, the famous hair loss researcher Dr. Angela Christiano maintained that JAK inhibitors could also work on AGA. This statement was later expanded and it was postulated that only “selective topical covalently bound JAK 3 inhibitors” could work, while oral ones would probably not work.

Moreover, of the two main currently FDA approved JAK inhibitors: 1) ruxolitinib only inhibits JAK 1 and JAK 2; and 2) while tofacitinib inhibits both JAK 1 and JAK 3, some suggest that its impact on JAK 3 is not very significant (or especially “selective”).

Aclaris Therapeutics to Test Decernotinib on AGA Patients

Today morning, I got a press release e-mail from Aclaris (which holds all the patents for JAK inhibitors and hair loss disorders) linking to an article titled: “Aclaris Therapeutics Announces Notice of Allowance for Two U.S. Patent Applications Covering Baricitnib and Decernotinib, Respectively, for Hair Loss Disorders“.

Several readers also posted other links about this news or e-mailed me, and of course some mentioned “nasa_rs”, a former NASA employee who comments on this blog all the time. If I had to summarize, most of “nasa_rs”‘ comments are in the form of “JAK inhibitors will cure hair loss or its all over.” But once in a while he also posts something extremely unique and useful.

The most interesting part of Aclaris’ press release is that they finally named the selective JAK 3 inhibitor that they will probably use to test on AGA patients when they start clinical trials. This particular JAK inhibitor is called decernotinib (VX-509), and it is a highly selective JAK 3 inhibitor. In Aclaris’ latest press release, the below pasted sentence is the key one (with the “respectively” implying the AA–>baricitinib and AGA–>decenotinib relationships):

The claims of these newly allowed patent applications cover methods of inducing hair growth and treating various hair loss disorders, including alopecia areata and androgenetic alopecia, by administering baricitinib or decernotinib, respectively.

Interestingly, decernotinib has no separate wikipedia entry at present (unlike most of the other “-tinibs” out there). The wikipedia entry on JAK inhibitors lists all the FDA approved JAK inhibitors that we have discussed as well as numerous others currently in clinical trials.