Follicum AB ('Follicum' or 'the Company') announced 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. 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 fourth quarter of 2020. FOL-005 is a modified, short version of the endogenous protein, osteopontin. In two completed clinical studies, treatment with FOL-005 has been shown to be effective and safe. The first study was done in healthy volunteers while the other one was conducted in alopecia patients, i.e. in men with incipient baldness. In both studies, patients were treated at the clinic with intradermal injections, 2 or 3 times a week. Alopecia means hair loss. This may be due to a number of causes. The most common form is called Androgenic Alopecia or male hair loss and affects the majority of all men but also a very large proportion of women. It is by far the most common form of hair loss. It is known that high levels of and high sensitivity to a sex hormone called dihydrotestosterone (DHT) leads to an increased risk of hair loss in men and women. Simply put, it can be said that the hormone causes the hair follicles to shrink and no longer produce a pigmented hair.