Follicum files international patent application conferring extended protection for the topical formulation of FOL-005 and other peptides.

The patent application is based on new experimental data that supports the use of the formulation for peptides other than FOL-005. The formulation of FOL-005 intended for topical application on the skin has been shown to provide good hair-stimulating effect in an animal model and has been tested in alopecia patients since the beginning of the year in a phase II clinical study in Germany.

If the patent application is granted, it will extend the protection also to cover peptides other than FOL-005. Furthermore, the protection of the FOL-005 product will be extended by at least eight years.

A new formulation

In parallel with the clinical development of FOL-005, Follicum has worked on the development of a new formulation of FOL-005 for topical application into the scalp. As previously reported, the new formulation has been tested in an experimental animal model and has shown good hair stimulating properties. The formulation is being tested in the a clinical study in Germany. Since the individual patient handles the treatment at home, it is possible to study several different dosages, and to increase the dosing frequency in a simple way, which minimizes the number of visits to the clinic during the study period.

Enables Follicum to enter into collaborations with other parties

The extended patent application that has now been submitted includes additional experimental data that support the use of the formulation for other peptides. Subject to the grant of national/regional patents based on the submitted international patent application, the protection of FOL-005 will be extended, and the use of the formulation for peptide-based drugs administered on the skin will be protected for indications other than alopecia. The extended patent protection enables Follicum to enter into collaborations with other parties interested in using the company’s newly developed formulation technology for their own products.

“We are very pleased to have developed a robust formulation of FOL-005 that the patient can use in a simple way. The challenges in developing functional, topical formulations of peptides, are to ensure that breakdown of the peptides is prevented, and to optimize their properties so that the product penetrates the skin. We have managed to meet these challenges with the new formulation, which has a long shelf life and is simple and very attractive for the patient to use. Based on this progress, we have filed an international patent application covering the use of the formulation for other peptides,” says Jan Alenfall, CEO, Follicum.