Follicum AB today announced that all patients have been included in the company’s ongoing Phase IIa clinical study with its lead drug candidate FOL-005. The study involves more than 200 male patients with hair loss who are being treated with a newly developed topical formulation of FOL-005. No noteworthy adverse reactions have been reported so far and to date none of the patients included have discontinued their participation in the study. The results are expected to be presented in spring 2021.
The ongoing double-blind and placebo-controlled Phase II study examines the safety and efficacy of FOL-005 in a new, cream-like formulation. Patients themselves apply one of three different strengths of FOL-005 or placebo to the scalp once a day. To evaluate the safety and efficacy of treatment, patients visit their respective clinic regularly during the four months study. The study is being conducted at three different clinics in Germany: The Clinical Research Center for Hair and Skin Science (“CRC”) in Berlin, proDERM in Hamburg and CentroDerm in Wuppertal. The last patient is scheduled to complete his treatment by the end of January 2021. Two previous clinical studies with FOL-005 have shown that intradermal injection of the drug candidate is an effective and safe treatment for stimulation of hair growth.
