Bringing science to hair loss

Follicum, founded in 2011, was created to further develop interesting findings obtained by its founders. They showed that a modified human protein potently increased hair growth in mice. Follicum is now also expanding into diabetes research with another modified human protein.

For some people, not having hair is a big problem, and for others unwanted hair is very stressful. Hair loss affects around a third of men between 20 and 50 years and approximately half of all men over 50. It is largely driven by genetics, and while for some people it is merely irritating, for others it has a major impact on their self-confidence. Women also develop male pattern baldness. In 2016, the hair loss treatment market was reported to be worth around $3.6 billion in the US alone. The US market continues to grow and new markets are opening up in countries like India and China.
Hirsutism (unwanted hair growth) can be a side effect of drugs, or a medical condition as a result of polycystic ovary syndrome or idiopathic hirsutism, and is particularly distressing for women. The hirsutism market is somewhat difficult to estimate; hair removal products, both mechanical and chemical/pharmaceutical, are considered to have a value of more than $11 billion in the US alone.

Hair loss and hair gain: Stop or go?
FOL-005, which is the most advanced drug candidate in Follicum’s pipeline, is a small peptide derived from a modified human protein (osteopontin). The peptide was identified in another research project, where it surprisingly showed induction of hair growth in mice.
"Finding active compounds by serendipity happens more frequently than you might think. For example penicillin, the hair growth product minoxidil which is the active ingredient in Rogaine, and Viagra [sildenafil] are examples of drugs that are based on serendipitous findings. Also off-target effects can lead to great treatments," says Jan Alenfall, CEO.
The results from a Phase I/IIa study of FOL-005 showed that the second lowest dose of FOL-005 injected into the skin on the forefront of thighs, stimulated hair growth by 8% in healthy volunteers, compared with a decrease of 2% with placebo. "Our next step is to advance FOL-005 into a Phase II trial on scalp baldness. This study will be designed to study optimal dose and dose frequency. We hope to begin a study of a more convenient topical formulation in 2018, though we are also looking at microneedle delivery," said Alenfall.
Follicum is also carrying out preclinical experiments with other modified human proteins for inhibition of hair growth, for potential use on both a medical and cosmetic market.

Facing the competition
The key competitors of FOL-005 are Rogaine (minoxidil), and Propecia (finasteride). Minoxidil is a topical preparation that can be bought over-the-counter, whereas Propecia is only available on prescription as an oral tablet.
"Users of Rogaine need to be aware that it should be used twice a day or the effect drops, it takes at least eight weeks to have an effect, and approximately only one third of the patients respond. A lower-strength version is available for women, as there can be unwanted systemic side effects with the higher strength product," said Alenfall. "Propecia inhibits the metabolism of testosterone to a more active form and can lead to side effects in both men and women."
FOL-005 appears to have fewer side effects than both Rogaine and Propecia, and may only need application a few times a week. This will, however, have to be confirmed in additional clinical trials.

Moving into diabetes
In a collaboration with Lund University, another modified human protein, FOL-014, has been observed to have impact on insulin release. Follicum has initiated a project for development of diabetes therapeutics.
"We have seen a striking effect. There is a lot of competition in diabetes, but FOL-014 may be the first in a new class of compounds," says Alenfall.
Follicum is participating in a diabetes research consortium that includes Novo Nordisk, Johnson & Johnson, Pfizer, Probi, CardioVax and Region Skåne/Malmö General Hospital and the research performed within this consortium is supported through the Foundation for Strategic Research, based in Stockholm, Sweden.
"Being part of this consortium validates our data and our approach, and allows us to share our results with potential partners," says Alenfall.

Working in collaboration
As a small start-up company without the resources needed for late stage drug development and marketing, Follicum plans to develop drugs until the proof-of-concept stage, initiating discussions with potential partners either just before, during, or just after Phase II. Currently, Follicum is ready to initiate advanced discussions with partners for FOL-005.
"We will talk to pharmaceutical and cosmetic companies with dermatology experience. At present we expect the FOL-005 product to be a prescription drug or one that is supplied by specialist clinics, but we will define a detailed strategy with our potential partners," says Alenfall.


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