Category Archives: Osteopontin

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.

Follicum

Several days before I posted about IGF-1 and Follicept on March 30th someone e-mailed me to let me know that there was a new player in town called Follicum. Adding to the confusion is that there is also a much older and much hyped player in the hair world by the name of Follica that I have briefly mentioned in a few posts on this blog (and might cover in more detail in future). I wonder if I can start a company called “Follicle” or if that word is not allowed to be used as a company name?!

Follicum and its FOL-005 Hair Growth Product

Getting back to Follicum, the company is publicly traded and based in Sweden and has an unusual product under development called FOL-005. It is a small peptide designed for hair growth regulation through topical administration. It has a unique proprietary formulation based on a modified part of the endogenous human structural protein osteopontin.

The interesting thing about this product is that it can both inhibit hair growth as well as encourage hair growth. This would enable the drug to be used to reduce excess body hair (hirsutism), as well as to grow scalp hair.  I suspect that FOL-005 has some type of anti-androgenic properties.

Because this product has yet to undergo any clinical trials, I was not too keen to write a post about Follicum. However, I found some of the things about this company and its FOL-005 product interesting and therefore changed my mind. For one, the results from pre-clinical trials conducted by contract research organization Dabur Research Foundation (DRF) in India seem to indicate superior results from FOL-005 in comparison to Minoxidil. DRF also conducted similar studies with Minoxidil in the past and seems to be a reputable organization.

I find this whole idea of outsourcing pre-clinical trials quite interesting. It seems like new small-scale western drug producers can now get pre-clinical trials done for cheap in countries such as India. They can then skip expensive and lengthy stage 3 clinical trials by introducing their product in Japan, where there are more favorable regulations. We are finally moving faster.

As far as Follicum goes, there was a recent March 2015 article on the company in Life Science Sweden magazine. Of further note, the company could soon be working with relatively well known hair loss researcher Jennifer Klopper at The University of Lübeck in Germany. And with the The Fraunhofer Research Institution for Marine Biotechnology EMB, also in Lübeck. The University of Lübeck is renowned as one of the world’s topmost institutions when it come to science and medicine. It seems like the city of Lübeck will be one of the world’s many biotech hubs in the coming years.