Mån 4 dec / År 41 / Nr 5 2023

Follicum: Moving onwards and upwards

Founded in 2011 to further develop a peptide that modulates hair growth, Swedish company Follicum is expanding its focus from alopecia to peptide-based drugs for other indications including diabetes.

Based in Lund in Sweden, Follicum is a clinical-stage public biotech company that has a lead molecule in clinical trials for alopecia. The company is based around the 2004 research on a modified version of the protein osteopontin, showing that it increased hair growth in mice. The second strand of research is into a new class of peptides in the treatment of diabetes.

Developing treatments for baldness
By the age of 35, two-thirds of men have a degree of unwanted hair loss, and this rises to 85% after the age of 50. Hair loss in women is also common; around 40% of people with hair loss are women. There are currently only two pharmaceuticals on the market, and both of these are associated with side effects.
“How we look is important, and it has a large impact on confidence and self-esteem. However, hair loss isn’t always taken seriously,” said Jan Alenfall, CEO, Follicum.
Follicum’s lead molecule, FOL-005, is in development for alopecia and moved into a phase I/IIa trial in Germany in 2016.
“FOL-005 is now in a second phase IIa trial for hair loss, which is a great achievement,” said Alenfall.
The new study involves 60 alopecia patients, who are given one of four different doses of the peptide or placebo as an injection in the scalp. The study is expected to be completed in autumn 2018.
“We want to develop a product that is efficient and simple to use. For an attractive topical formulation, we have been looking at the stability of the peptide in different topical formulations, and whether the peptide penetrates through the skin into the site of action in deep dermis. We are now very happy that we have managed to developed an elegant formulation meeting all our expectations ” said Alenfall.

Moving forward into diabetes
Diabetes, particularly type 2 diabetes, affects increasing numbers of people worldwide. To meet this need, Follicum is developing a new class of peptides that stimulates insulin release with effects comparable to, or better than, existing diabetes treatments.
“We are currently screening these compounds in cell based models and in experimental animal models, and aim to have a candidate peptide selected around year end,” said Alenfall. “The new peptide class doesn’t seem to have the same mechanism of action as the GLP-analogues currently used in diabetes treatment.”
Follicum is also assessing the peptides potential in specific diabetes subgroups, and in diabetic complications such as non-alcoholic steatohepatitis, diabetic retinopathy, diabetic neuropathy and cardiovascular disease.
“There are a lot of competitors and many drugs coming up in the diabetes pipeline. So, we don’t want to develop just one more insulin-releasing compound. Instead we want to take a much more holistic approach,” said Alenfall.
Follicum is part of a comprehensive diabetes project led by Lund University and funded by the Foundation for Strategic Research. Other organisations involved include Pfizer, Novo Nordisk, Johnson & Johnson Innovation, Probi, CardioVax, Region Skåne, and Skåne University Hospital and through this project Follicum collaborates with many world-leading researchers in diabetes.

Looking to the future
Follicum’s aim is to take its drug candidates to a clinical proof-of-concept stage, and then seek partners for further development and marketing.
“There has been a lot of interest from potential partners and from the public over FOL-005,” said Alenfall. “The currently used formulation, an injection, limits its use but the development of an efficient topical formulation has been followed with great interest.”
The studies in diabetes are still in a very early phase, but the company has already been approached by some interested parties.