First patient treated in Follicum’s Phase IIa study of FOL-005 for stimulation of hair growth
Lund, Sweden, March 7, 2018: Follicum AB (“Follicum” or “the company”) today announced that the first patient has been treated in the Phase IIa clinical trial in Germany with its lead candidate FOL-005 on 60 patients with hair loss. The study is conducted at Clinical Research Center for Hair and Skin Science (“CRC”) in Berlin and bioskin, Hamburg, Germany. The global market for pharmaceutical hair loss products for both men and women is estimated to be worth $3 billion. The available drug products have unwanted side-effects that limit their use.
FOL-005 is a modified short version of the endogenous protein, osteopontin. In the recently completed phase I/IIa study, FOL-005 was shown to be effective and safe in stimulating hair growth with 3 out of 4 subjects responding with increased hair growth. The present Phase IIa study aims to investigate the safety and effect of different doses of the drug candidate FOL-005 or placebo, administered as injections at two sites on the scalp. The study is expected to be completed in late 2018.
CEO Jan Alenfall commented:
”This is a major milestone for Follicum. 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.”
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 March 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