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.