Successful meeting with the German Medicines Agency regarding preparations for topical phase II scalp study
Follicum AB ("Follicum" or "company") today report that the company has had a successful scientific advisory meeting regarding the hair project FOL-005, with the German authority, BfArM.
In accordance with the previously announced timetable, Follicum has prepared a background document for scientific advice with the German Medicinces agency BfArM. The meeting discussed which additional toxicity studies should be done to supplement Follicum's existing toxin programs and partly the design of a future clinical study. BfArM confirmed that the smaller toxin program proposed by Follicum well covers the issues that need to be addressed before a clinical study with the new formulation can be started. This means that Follicum will be able to begin the forthcoming clinical study according to plan during the end of 2019 / early 2020.
CEO Jan Alenfall comments
-We are very pleased with the constructive discussion we have had with BfArM. The proposed package of complementary toxin studies was deemed acceptable to support starting the new clinical study. The clinical study is planned to be carried out in Germany where Follicum has previously had good contacts with two clinics, Charite and bioskin. Both of which have broad expertise and extensive experience of hair studies, and which Folliucm has collaborated with in previous clinical studies. We intend to submit an application for the start of the Phase IIa study with the new topical formulation to BfArM in the autumn of 2019, according to the previously communicated schedule.
For further information, please contact:
Jan Alenfall – CEO, Follicum AB
Telephone: +46 46 19 21 97
FOL-005 is a modified, short version of the endogenous protein, osteopontin. In two completed clinical studies, treatment withFOL-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. Planing for a phase II study is currently underway aiming at investigating the hair-stimulating effect of treatment with different doses of the new topical formulation.
About Follicum AB
Follicum is a biotech company focusing 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, Follicums research has resulted in a new peptide class which significantly increases the release of insulin 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 Spotlight since 2014. www.follicum.com. www.follicum.com.