Category Archives: FOL-005

FOL-005, Follicum, Hirsutism

Follicum Commences Human Trials for FOL-005

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I first covered the relatively new Sweden-based company called Follicum in April of last year. Thereafter, the company made a few announcements via press releases that I largely ignored since it was yet to commence phase 1 human clinical trials. And we all know how long those take, even after accounting for newer regulations in some countries that can shorten the time.

Follicum Begins Phase 1 Clinical Trials

However, last week Follicum finally announced that they had commenced phase 1 clinical trials of their FOL-005 product. This product can interestingly both inhibit hair as well as stimulate hair, although it seems like the company might be naming the hair stimulation product something else down the road, and it could be slightly different from FOL-005. According to Follicum, both the hair inhibition and hair stimulation products are based on “a large human protein which has been manipulated and modified.”

They currently have 1 patient on whom the drug is being tested upon, but aim to have a total of 30 patients soon. The study is being undertaken at the highly respected Charité — Universitätsmedizin Berlin that I have covered on this blog before. This makes me take Follicum a bit more seriously.

The company’s research on mice (undertaken by contract research organization Dabur Research Foundation in India) suggests that this product will be significantly superior to Minoxidil when it comes to scalp hair growth.

Note that the current press release by the company only mentions testing FOL-005 for hair inhibition (important for those who suffer from excessive body hair, aka hirsutism). But I assume they will also be doing testing for hair stimulation with another similar product or the same product? I am not interested enough for the time being to ask the company about that important detail, but perhaps will do so after they come out with one more press release in the coming months. My intuition tells me that the hair stimulation product will have a different name and slightly different chemistry.

I was reluctant to write an entire post on Follicum, but changed my mind after a request on the hair loss chat on this site. And also because my monthly brief items of interest post is still over two weeks away.

Dabur Research, FOL-005, Follicum, Hirsutism, Osteopontin, The University of Lübeck

Follicum

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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.