Follicum AB has reported top-line data from a Phase IIa study in Berlin and Hamburg, Germany. The first-in-man scalp trial examined the safety and therapeutic effect of different doses of lead candidate FOL-005 injected three times per week.
FOL-005 is a modified short version of the endogenous protein, osteopontin. As previously reported, a fortuitous finding – wherein mice injected with the modified protein developed hair – prompted the Swedish biotech’s entry into the alopecia space.
According to Follicum, the Phase IIa study confirmed FOL-005 is safe with minimal side-effects reported. Hair growth increased on average by seven hairs per cm².
"The highest dose showed that the treatment resulted in both increased hair growth and a substantial increase in the number of hair follicles in growth phase. This is of great importance for alopecia patients who have a reduced hair growth period,” said CEO Jan Alenfall.
In the placebo group, however, the proportion of hair follicles in growth phase decreased, said Alenfall. “The clear effect we saw in the growth phase supports the hypothesis that FOL-005 can ‘awaken dormant hair follicles’.”
Follicum will now plan an efficacy trial with a topical formulation of FOL-005 to study dosage and dosing frequency. “In parallel, the company will focus on finding a suitable partner for further development of FOL-005,” according to the firm.