Follicum files patent application for new topical formulation for hair loss

Using easy-to-apply cream instead of direct scalp injection would extend patent protection by 8 years.

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. The new formulation, which has been tested in an experimental animal model and showed good hair stimulating properties, 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 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.

CEO Jan Alenfall comments: “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 shelf life and is easy and very attractive for the patient to use. This has given us the confidence to file a new patent application.”