Lund, Sweden, September 26. Follicum today announces the signing of a cooperation agreement with Bioglan AB for the production of clinical trial material of Follicum’s new, cream-like formulation of FOL-005 for topical treatment. The formulation will be used in the Phase II clinical trial on hair loss, which is expected to start in the beginning of 2020.
In mid-June this year, Follicum announced that the company had conducted a successful, scientific advisory meeting with the German Medicines Agency, BfArM, concerning the upcoming clinical trial with FOL-005. As previously communicated, the company expects to be ready to start the new Proof-of-Concept study with FOL-005 in early 2020. Preparations for the clinical trial are ongoing and Follicum has established a collaboration with Bioglan in Malmö for the formulation and manufacture of the product to be used in the study as well as for the development and validation of necessary analytical methods. The product is a cosmetically attractive, cream-like formulation for topical treatment.
Jan Alenfall, CEO Follicum comments:
– Preparation work for the new clinical study with FOL-005 is in full swing and we have now also established a collaboration with Bioglan, a company we have great confidence in. The company is reputable, it manufactures products for a large number of pharmaceutical companies and has a solid track record. Delivery of the finished, cream-like product is expected to take place well in advance of the start of the clinical trial early next year.
Simon Björklund, CEO, Bioglan comments:
-The therapy area is an interesting one where effective treatment methods are sought after and where a well-functioning topical product has great potential to help many people. The collaboration is interesting and important for Bioglan and we obviously hope for a positive outcome in the upcoming study.
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.
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 September 26, 2019.
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.
Bioglan is a pharmaceutical company with long and solid experience of innovation, product development, manufacturing of products for clinical trials and commercial production of topical products for smaller companies to multinational drug giants. http://www.bioglan.se