About Moberg Pharma
Moberg Pharma AB (publ) is a Swedish pharmaceutical company with a focus on the commercialization of proprietary medicines based on proven substances. The company’s main asset is MOB-015 – a new topical treatment for nail fungus. Phase 3 clinical studies of more than 800 patients for MOB-015 indicate that the product has the potential to become the future market leader in onychomycosis. Moberg Pharma has agreements with commercial partners on site in Europe and Canada, among others. MOB-015 was recommended for market approval in the EU June 2023.
About MOB-015 and Onychomycosis
Nail fungus is a common infection that affects 5-10% of the population, where many patients are currently untreated. The global market potential is very large with more than one hundred million patients and a clear need for better products. Moberg Pharma estimates that the annual sales potential for MOB-015 amounts to 250-500 MUSD. MOB-015 is a proprietary topical formulation of terbinafine developed by Moberg Pharma and based on the company’s experience with the leading over-the-counter nail fungus treatment Kerasal Nail[®]/Emtrix[®]. Terbinafine is currently the most widely used tablet treatment against nail fungus but carries risks such as interactions with other drugs and liver damage, which are avoided with topical treatment. Previous attempts at topical treatment with terbinafine have failed due to the difficulty in delivering enough active substance through the nail.
The company’s lead asset MOB-015 was recommended for national market approval in 13 European countries in June 2023 and is undergoing a phase-3 study in North America. The company has secured partner agreements for MOB-015 with a combined value of milestones of up to 70 MUSD, of which milestones of 6.5 MUSD have already been paid, in addition to compensation for delivered products in Europe, Canada, Israel and South Korea with market leading players. MOB-015 has the potential to become the market-leading drug as the product has a world-leading ability to kill nail fungus (76 percent, in relation to 30 to 55 percent for competing external preparations). The primary treatment objective was achieved in both the North American phase 3 study and the European phase 3 study. MOB-015 is being prepared for launch in Scandinavia and is currently being evaluated over 52 weeks in a randomized and vehicle-controlled phase 3 multicenter study. A total of around 350 nail fungus patients are expected to be included from the USA and Canada. Patient recruitment is expected to be completed in 2023 and topline results are expected in the first quarter of 2025.