Follicum today announces that the company has successfully completed the supplementary toxicology studies that will form the basis of the forthcoming clinical study with the topical formulation of FOL-005. The company expects to be ready for the start of the clinical study in patients with hairloss (alopecia) in early 2020.
Preparations for the clinical trial are ongoing and the completed toxicology studies mark the achievement of an important milestone. Follicum has previously conducted several extensive toxicology studies with FOL-005 in which the substance was injected subcutaneously. The new results clearly indicate that the topical formulation is completely safe to use for patients. The results will be included in the application to the German Federal Institute for Drugs and Medical Devices (BfArM) [corrected] (
Swedish Medical Products Agency) for starting the clinical trial. Other preparations also proceed according to plan and Follicum expects to begin the upcoming clinical trial in early 2020.
CEO Jan Alenfall comments:
– The outcome of both the new and the previous toxicology studies shows that FOL-005 does not give rise to any negative effects or injuries. Other preparations for the clinical trial are in full swing. The upcoming clinical trial is planned to be conducted in Germany where Follicum has good previous experience. The company intends to submit the application for starting the phase IIa study on alopecia patients with the new formulation to the German Medical Products Agency in the autumn of 2019.
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, FOL-005 proved to be an effective and safe treatment. Already after three months of treatment, a clear effect on hair growth could be detected. The patients have been injected three times a week in these studies. As the next step in the development, the company will plan to start a clinical effect study with a topical formulation of FOL-005 where dose, dosage frequency and treatment length will be optimized. In parallel, the company will focus on finding a suitable development partner for FOL-005.
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, 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.