Moberg Pharma AB initiates Phase III program for MOB 015 to treat onychomycosis.

Moberg Pharma AB announced that patient enrollment has started in U.S., Canada and Germany in the Phase III program investigating MOB 015 for the treatment of onychomycosis. MOB 015 is being evaluated over 52 weeks in two randomized, multicenter, controlled Phase III studies. The primary endpoint in both studies is the proportion of patients achieving complete cure of their target nail. In total, approximately 700 patients are expected to be enrolled in the two studies. In addition to the previously announced approvals of a North American Phase III study from the FDA and Health Canada, a European Phase III study was recently approved by the regulatory authority in Germany. Moberg Pharma is also expecting approval from the Polish authorities.

Comment:In a phase II study, MOB 015 demonstrated delivery of high microgram levels of terbinafine into the nail and through the nail plate into the nail bed. Mycological cure of 54% and significant clear nail growth was observed in patients who completed the phase II study. The results are remarkable, particularly when taking into account the severity of the nails included in the study � on average approximately 60% of the nail plate was affected by the infection. Plasma levels of terbinafine with MOB 015 were substantially lower than after oral administration, reducing the risk of liver toxicities observed with oral terbinafine.