Follicum Phase IIa study of FOL-005 against hair loss approved by the German Medicines Agency
Lund, Sweden, February 7, 2018: Follicum AB (“Follicum” or “the company”) today announced it 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 limits 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.”
For further information, please contact:
Jan Alenfall – CEO, Follicum AB
Telephone: +46 46 19 21 97
This information is information that Follicum is obliged to make public according to the EU Market Abuse Regulation. The information was provided through the agency of the contact persons above, for publication on the 7th February 2018.
About Clinical Research Center for Hair and Skin Science (CRC), Berlin, Germany
The Clinical Research Center for Hair and Skin Science (“CRC”) is part of the skin clinic at the Charité University Hospital in Berlin. CRC conducts experimental research and offers specialist expertise in the field of skin and hair research. CRC has conducted a number of clinical studies in various hair indications and has a solid qualification area specializing in clinical phase I and II studies.
About bioskin, Hamburg, Germany
bioskin is a full-service CRO specializing in dermatology that provides services for clinical development of dermatologically oriented products, especially for both early phase/PoC and late phase studies. bioskin has 25 years of experience in clinical studies in this area. bioskin has previously conducted several clinical studies in various hair indications and has impressive qualifications. The head office is located in Hamburg and is privately owned.
About Follicum AB
Follicum is a biotech company focused on the discovery and development of peptide-based drugs. The primary focus is in hair growth stimulation, where Follicum has obtained very promising results with FOL-005 in a recently completed clinical trial. In diabetes, the drug candidate FOL-014 has demonstrated an increase in insulin release in pre-clinical models. The company was founded in 2011, and is based in Lund, Sweden. Follicum is listed on the Swedish small cap exchange Aktietorget since 2014. www.follicum.com