Follicum AB (“Follicum” or the “company”) announces that the company has filed an international patent application (PCT) covering the formulation of FOL-005 developed by the company. 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 8 years.
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.
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 the company’s newly developed formulation technology for their own products.
CEO Jan Alenfall comments: “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”.
Unwanted hair loss (alopecia), which is commonly referred to as “baldness”, affects about a third of all men between the ages of 20 and 50 in the Western world. For men over 50 years of age, the proportion with hair loss is even higher, about 50%. A significant proportion of women also suffer from unwanted hair loss. All in all, this translates to a huge market for an effective and safe hair-stimulating drug. Today, there are principally only two medicinal substances used for treatment. Sales of these drugs amount to more than USD 3 billion annually. Compared to existing preparations, FOL-005 is likely to offer several benefits, such as fewer side effects, easier dosage and higher proportion of responders.
For further information, please contact:
Jan Alenfall – CEO, Follicum AB
Phone: +46 709 31 51 15
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 12 May, 2020.
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 several clinical trials. In diabetes, Follicums research has resulted in a new peptide class which significantly increases the release of insulin in preclinical 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.