German Medicines Agency sees potential in FOL-005 - a modified version of the endogenous protein, osteopontin - the green light for further studies.
Follicum has received approval from the German Medicines Agency (BfArM) and German Ethics Committee to commence a Phase IIa clinical trial in Germany with its lead candidate FOL-005 on patients with Alopecia (hair loss). The trial will include approximately 60 patients and be run in collaboration with the Clinical Research Center for Hair and Skin Science (CRC) in Berlin and Bioskin, Hamburg, Germany. Currently, there are no effective products available for men and women in what is estimated to be a global market worth $3 billion. Furthermore, the drug products available have unwanted side-effects that limit their use.
FOL-005 is a modified version of the endogenous protein, osteopontin and previously in a clinical study was shown to be effective in stimulating hair growth without side effects. The Phase IIa study aims to investigate the effect and response of the drug candidate FOL-005, on the scalp with injections. Treatment will be performed on two surfaces of the scalp where different doses of FOL-005 or placebo will be administered. The study is expected to be completed in 2018, with results communicated in the same year.
CEO Jan Alenfall commented: “The BfArM and Ethical committee approval keeps us on our intended schedule. Our intention with the forthcoming study is to confirm the interesting results from the recently completed study, where we saw both good efficacy and safety as well as a very high patient response. Hair loss is a poorly served indication, with little innovation or success to date. We hope that FOL-005 will provide a breakthrough.”
CEO Walter Wigger-Alberti, Bioskin commented: “We are delighted to collaborate with Follicum in this study. Hair loss is a serious condition leading often to low self-esteem and there has been little progress in its treatment.”Read More