Follicum today announces that the company has signed a collaboration agreement with proDERM for conducting the new clinical trial with a cream-like formulation of FOL-005 to be tested on alopecia patients (patients with hair loss). The company expects to be ready for starting the clinical trial shortly after the turn of the year.
Preparations for the clinical trial are ongoing and through the agreement with the German company proDERM the completion of the study has been secured. proDERM specializes in conducting clinical studies with a focus on hair studies and has the necessary prerequisites for conducting clinical trials meeting the highest quality requirements. The remaining preparations for the study are also proceeding according to plan, which means that Follicum, unless something unforeseen occurs, will be able to start the upcoming clinical study shortly after the turn of the year.
CEO Jan Alenfall comments
– Preparations for the clinical trial are in full swing and we are very pleased to have signed an agreement with proDERM, thus representing an important milestone for conducting the new study on alopecia patients. proDERM is a highly qualified partner with extensive experience in hair studies. The upcoming clinical study will, in accordance with previous plans, be carried out at two clinics, in part at Charité University Hospital with which Follicum has conducted previous collaborative clinical studies and at proDERM. Both clinics have broad expertise and extensive experience from performing hair studies. We intend to submit the application for starting the phase IIa study with the new formulation to the German Federal Institute for Drugs and Medical Devices (BfArM) in November.
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. The first study was done on healthy volunteers while the second was done on alopecia patients, i.e. on men with beginning baldness. In both studies, patients at the clinic were treated with intradermal injections, 2 or 3 times a week. Currently, a phase II (Proof-of-Concept) study is underway to investigate the hair-stimulating effect after treatment with various strengths of the new topical formulation.
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.
proDERM is a leading international contract research organization in Hamburg, Germany, specializing in conducting clinical studies in the areas of skin, mucosa, hair, eyes and mouth. proDERM carry out studies on medicinal products, medical devices, cosmetics, nutritional supplements and consumer goods alike, and competently comply with the various regulatory and legal requirements. proDERM is a competent, full-service partner, supervising clinical projects in all phases.