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Follicum’s Phase II study approved by the German Medicines Agency

FDA approved

Follicum has received approval from the German Medicines Agency (BfArM) and the German Ethics Committee to start a Phase IIa clinical study with a topical formulation of FOL-005 on patients with alopecia (hair loss).

The trial will comprise about 200 patients who will be treated with FOL-005 or placebo daily for 4 months. The study is conducted in collaboration with the Charité Clinical Research Center for Hair and Skin Science in Berlin and proDERM, Hamburg, Germany.

In two previous clinical studies, FOL-005 has been shown to be an effective and safe treatment for stimulation of hair growth. The upcoming phase IIa study aims to investigate the safety, efficacy of and response to the drug candidate FOL-005 applied as a topical formulation. Once daily in the evening, the patients will themselves apply one of three different strengths of FOL-005 or placebo to the scalp. The study is expected to be completed and the results communicated in Q4, 2020.

“We are very pleased that we have now received the  “green light” from both the German Medicines Agency and the Ethics Committee to start the new study with FOL-005. Other preparations are also in place and we expect patient recruitment to begin soon. In this study, patients apply the topical formulation of FOL-005 or placebo once daily, thus both simple and practical for repeated long-term treatment. We now look forward to conducting the study together with CRC and proDERM and we look forward to results at the end of the year,” says CEO Jan Alenfall.