A Phase II study with FOL-005 for treatment of Alopecia approved by the German Medicines Agency
Follicum AB (“Follicum” or “the Company”) today announces that it 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 (“CRC”) in Berlin and proDERM, Hamburg, Germany.
Follicum’s most advanced drug project FOL-005, is being developed to stimulate hair growth in patients with hair loss, alopecia. The most common form of alopecia is called Androgen Alopecia and affects the majority of men but also a very large proportion of women. The illness is stigmatizing for the affected person and often leads to reduced self-esteem, which can greatly impact the patient’s daily life.
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, the 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.
Well established study centres
Just like the previous clinical studies with FOL-005, the now approved phase IIa study will be carried out in collaboration with the Charité Clinical Research Center for Hair and Skin Science (CRC) in Berlin. This time Follicum will also collaborate with the CRO proDERM in Hamburg.