Moberg Pharma AB announced that its topical terbinafine formulation, MOB-015, failed to meet the primary endpoint in a North American Phase 3 study for the treatment of onychomycosis (nail fungus). The trial, conducted across 33 centers in the US and Canada with 384 patients, evaluated an 8-week daily dosing regimen followed by weekly maintenance, a departure from the daily dosing used in the EU-approved regimen.
The primary endpoint, defined as the proportion of patients achieving complete cure of the target toenail at 52 weeks (both a completely clear nail and mycological cure), was achieved in only 1.5% of patients receiving MOB-015, compared to 0% in the vehicle group (p=ns). However, mycological cure, defined as both negative KOH and negative dermatophyte culture, was achieved in 25.0% of the patients on active treatment (p=0.030). Treatment success (mycological cure and almost or completely clear great toenail) assessed by the investigator was achieved in 11.2 percent of the patients in active treatment (p=0.003).
Strategic Shift to European Market
As a result of these findings and a strategic review by Bayer Consumer Health, the planned launch of MOB-015 has been discontinued, and Moberg Pharma will regain full rights to the drug in the EU. Anna Ljung, CEO of Moberg Pharma AB, stated, "While the topline results of the North American study creates new conditions, the data reinforce the superior efficacy of daily dosing, which is already approved and thriving in the Swedish market. We now have the opportunity to establish a stronger presence in EU and capturing a larger part of the value chain for this great product."
Moberg Pharma intends to focus on the European market, leveraging the existing marketing authorization in 13 EU countries and the successful launch of Terclara®, the brand name for MOB-015 in Sweden, where it has become a market leader. The company aims to secure a larger share of the value chain in Europe by taking an active role in commercialization and establishing a stronger direct presence, including ownership of the brand. Discussions with potential partners in Europe are underway to optimize the path forward.
Onychomycosis and MOB-015
Onychomycosis affects approximately 10% of the general population, with a significant portion remaining untreated. MOB-015 is a topical formulation of terbinafine designed to deliver effective concentrations to the nail and nail bed, avoiding the systemic exposure associated with oral terbinafine, the current gold standard treatment. While oral terbinafine is effective, it carries risks of drug interactions and liver damage. MOB-015 has demonstrated superior mycological cure rates (76% vs up to 42% for comparators) and a significantly better complete cure rate compared to vehicle in previous Phase 3 trials supporting its EU approval, without any serious adverse reactions.
Safety and Tolerability
In the North American Phase 3 trial, MOB-015 was generally well-tolerated, with no safety issues identified and no serious adverse events related to the drug reported.
