Follicum has announced that more than 50% of the patients have been recruited in the ongoing, clinical phase IIa study with FOL-005.
The study involves 200 male patients with hair loss who are treated daily for four months with a newly developed topical formulation of FOL-005 or placebo. The study is being conducted at the Clinical Research Center for Hair and Skin Science in Berlin, at proDERM in Hamburg and at CentroDerm in Wuppertal.
An important milestone
Two previous clinical studies have shown that intradermal injections of FOL-005 are an effective and safe treatment for stimulation of hair growth. The current Phase II study aims to investigate the safety, efficacy and response of the drug candidate FOL-005 in a topical formulation. Patients themselves will apply one of three different strengths of FOL-005 or placebo to the scalp, once a day during the evening. The results of the study are expected to be communicated in spring 2021.
“The fact that more than half of patients are now recruited is an important milestone for Follicum. We are very relieved that we are one of few pharmaceutical companies have not suffered significant delays in an ongoing study due to the Covid-19-pandemic. We are following the planned recruitment rate after a temporary break and we are working intensively to achieve the recruitment goal so that patients can undergo final treatment before the end of the year. The current study is intended to confirm the interesting results we have seen in previous studies, now in a larger patient group and with the cream-like formulation developed and tested over the past year,” says Jan Alenfall, CEO, Follicum.