The Swedish biotech’s lead candidate, FOL-005, is a modified short version of the endogenous protein, osteopontin. According to CEO Jan Alenfall, both the company and its lead investigational therapy were founded on a serendipitous finding.

“Scientists were working on atherosclerosis, with a particular interest in the potentially inflammatory role of osteopontin in unstable plaques in the blood vessels,” ​he explained to us at Nordic Life Science Days in Stockholm yesterday.

“​The researchers made different versions of osteopontin, whereby modifications were made in a particularly important site in osteopontin. To study the inflammatory response, they injected it into mice and saw hair growth in just one of the modified osteopontin variants,” ​he added. ​

Once founded, company employees did several hair growth studies to verify the founders’ original data, injecting mice with several variants of osteopontin – including the human analogues.

“FOL-005 peptide, originates from the human version. FOL-005 is now in clinical Phase IIa in Germany and we expect the data soon before Christmas,” ​Alenfall told us.

The Phase IIa study is being conducted at the Clinical Research Center for Hair and Skin Science (CRC) in Berlin, and at Bioskin, Hamburg.

Formulation plans​

Alenfall said he hopes FOL-005 will compete with the limited number of approved hair growth products available.

“There are only two products on the market today,” ​said Alenfall, referencing minoxidil and finasteride. “They are very old and not so effective. They also have a lot of side effects,” ​he added.

“Only one of them [minoxidil] can be used in males and females, so we want to contribute to this and develop a product with at least similar efficacy, but much safer, that can be used in both males and females,” ​he continued.

According to Alenfall, Follicum’s next step is to provide an ‘easy-to-use’ formulation.

“We have been successful in making a stable, peptide formulation for delivery on the scalp. By loading the hair follicles with this formulation, we can deliver the compound into the skin without any injections. This is a significant shift.” ​

Alenfall told us the firm is looking for licensing partners to advance FOL-005 through to commercialisation.

Other developments in the alopecia – often referred to as ‘balding’ – space includes Canadian biotech RepliCel’s autologous cell-therapy​. RepliCel’s lead investigational therapy, RCH-01, uses patient-derived stem cell to rejuvenate and stimulate hair growth.