Follicum applies for the start of a Phase II study at the German Medicines Agency
Follicum AB ("Follicum" or "the company") today announced that the company has filed an application for the initiation of a Phase IIa clinical trial with FOL-005 on scalp to study hair growth to the German Medicines Agency, BfArM and to the Ethics Committees. The goal is to start the study after approval by the authorities early 2018.
Preparations for the new clinical Phase IIa study with FOL-005 on scalp are progressing as planned, and we have now reached an important milestone in submitting the application to the authority and Ethics Committees in collaboration with the Clinical Research Center for Hair and Skin Science ("CRC") in Berlin and Bioskin, Hamburg, Germany. The notice regarding the application is expected to arrive around the turn of the year. Follicum plans to start the study in the first quarter 2018 with recruitment of patients both in Berlin and Hamburg.
The goal of Follicum's new clinical study is to investigate the effect and response of the drug candidate FOL-005, on the scalp with injections. The planned study will include approximately 60 patients with gradual hair loss. Treatment will be performed on two surfaces of the scalp where different doses of FOL-005 or placebo will be administered. The company intends to complete and communicate the results of the study in 2018.
CEO Jan Alenfall’s comments
" Submission of the application for the new clinical study on scalp is another important milestone for Follicum. Our intention with the forthcoming study is to confirm the interesting results from the recently completed study, where we saw good effect and safety as well as a very high patient response.”
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.
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 20th November 2017.
About Follicum AB
Follicum was founded in 2011 by two researchers in Lund, Anna Hultgårdh and Pontus Dunér, based on research around a human protein, osteopontin. Among other things, this protein is considered to be involved in the growth of bone tissue. Follicum has isolated a part of this protein and partially modified its amino acid sequence, which generated Follicum’s drug candidate FOL-005. In early studies, FOL-005 showed an ability to both stimulate and inhibit hair growth. During 2016/2017, the company conducted its first clinical phase I/IIa study. Follicum is based in Lund and was listed on AktieTorget in 2014. www.follicum.com