The company’s hair loss treatment projects are progressing according to plan and a patent application for an internally developed formulation of FOL-005 has been submitted.
The cream formulation is intended to be lubricated into the scalp and has demonstrated good hair-stimulating effect in an animal model. The next step involves running a clinical phase II study in alopecia patients which is expected to start at the end of 2019. If granted the patent application would extend the patent protection of FOL-005 by 8 years.
The new cream formulation has been developed in parallel with the clinical program of FOL-005. In previous clinical studies in alopecia patients, FOL-005 has been dosed by injecting a solution of the peptide locally, up to three times per week. In the first study, FOL-005 was injected into the thigh of healthy volunteers and in the second study, the peptide was injected onto the scalp of alopecia patients. In both studies, positive effects on hair growth were demonstrated. As previously mentioned, the new formulation has been tested in an experimental animal model and showed good hair stimulating properties and will be studied in a new clinical study planned to begin at the end of 2019.
Preparations for this study and discussions with authorities are currently underway. With the new formulation, it will be possible to study several different doses and increase the dosage frequency in a simple way, since the individual patient himself / herself will take care of the treatment at home. This simplifies the study and means that the number of visits to the clinic during the study period will be minimized.
“We are very pleased to have developed a formulation of FOL-005 that the patient can use in a simple way. The challenges of developing functional topical formulations of peptides are to prevent the peptide from breaking down and to optimize the conditions for it to penetrate the skin. We have managed to meet these challenges with the new formulation which has a long shelflife and is easy and very attractive for the patient to use. This has given us the confidence to file a new patent application,” says Jan Alenfall, CEO, Follicum.
Photo of Jan Alenfall