Moberg Pharma announces successful results for MOB-015 in a Phase II study for the treatment of onychomycosis

Moberg Pharma AB (OMX: MOB) announces successful top-line results from a phase II study for MOB-015 in onychomycosis (nail fungus). The primary endpoint, mycological cure after 15 months, was achieved in 54% of the patients.

The purpose of the study was to demonstrate proof-of-concept for MOB-015 in onychomycosis. The open-label clinical study including 25 patients was conducted at Sahlgrenska University Hospital, Sweden with Professor Jan Faergemann as the coordinating investigator. Patients with onychomycosis affecting 25-75% of at least one great toe nail received treatment with MOB-015 during 12 months and were followed for a total of 15 months. The study included patients with more severe onychomycosis than recently published studies of topical treatment alternatives. Of the 24 patients who completed the study, 13 (54%) met the primary endpoint, mycological cure, defined as both negative microscopy and fungal culture after 15 months from start of treatment. The secondary endpoint, mycological cure and excellent clinical improvement or cure was observed in 7 of 24 patients (29%). Biopsies confirmed high levels of terbinafine in the nail plate and nail bed (median values 1610 and 45 ug/g, respectively). MOB015 was generally well tolerated.

“The mycological cure rate and clinical outcome in the study are remarkable for a topical treatment. Especially since the majority of these patients had more than 50% nail involvement at inclusion. These results are promising for future phase III studies. An efficacious and safe topical terbinafine product would be highly attractive for Dermatologists worldwide“, stated Dr Jan Faergemann, M.D., Ph.D., Professor, Dermatology Unit at Sahlgrenska University Hospital.

“The excellent phase II results exceeded our expectations. MOB-015 has the potential to become a superior and leading product in the large and growing onychomycosis market. We are now proceeding with partner discussions for further development and commercialization of MOB-015”, said Peter Wolpert, CEO of Moberg Pharma AB