Moberg Pharma Reduces Expectations on Phase 3 Trial Endpoint After Subset Data

STOCKHOLM, Sept. 13, 2024 -- Moberg Pharma AB (OMX: MOB) announced the receipt of preliminary information regarding clinical cure rates in a subset of patients from the ongoing North American Phase 3 study for MOB-015, a treatment for nail fungus. The observed clinical cure rates in this blinded subset have fallen short of the company’s expectations, prompting Moberg Pharma to inform the market.

The North American Phase 3 study is being conducted across 33 centers in the US and Canada, encompassing a total of 384 patients. This study is crucial for the clinical data required for the registration and commercialization of MOB-015 in the United States. Unlike prior studies in 13 EU countries, this Phase 3 trial employs an altered dosage regimen: an initial 8 weeks of daily dosing followed by weekly maintenance doses for 40 weeks, rather than continuous daily dosing throughout the treatment period.

As the database is being prepared for the upcoming topline data, the company received partial information about the clinical cure in the study subset. Clinical cure is one of three essential components defining the study's primary endpoint, complete cure, which also includes negative fungal culture and negative microscopy. Complete data for these other parameters have not yet been obtained.

The information received is blinded, meaning it does not reveal which patients received the active treatment or the vehicle (placebo). It is also unknown how many patients in the subset received the active treatment, as participants were randomized in a 2:1 ratio to receive MOB-015 or the vehicle.

The number of patients achieving clinical cure in this subset is lower than anticipated, increasing the risk that the product may not be successfully commercialized in the US based on this study alone. Moberg Pharma deemed it necessary to disclose this information to maintain market transparency.

Maintaining the integrity of the study data is paramount to ensure its validity in discussions with regulatory bodies and to safeguard ongoing patient treatments. Moberg Pharma has refrained from speculating on the potential outcomes or future prospects of MOB-015 until topline results are available, to avoid premature conclusions.

"Our primary focus is preserving the data integrity of this study. In collaboration with our CRO, we aim to expedite the timeframe from the last patient’s final visit to the release of topline data, with the expectation that results may be available sooner than previously communicated, potentially before year-end," stated Anna Ljung, CEO of Moberg Pharma.

Moberg Pharma AB, headquartered in Stockholm, specializes in commercializing proprietary innovations based on drug delivery of established compounds. The company's primary product, MOB-015, is a topical therapy for onychomycosis (nail fungus) and holds market approval in 13 EU countries. It is marketed in Sweden as Terclara® and available in all pharmacy chains.

MOB-015 has undergone Phase 3 clinical trials involving over 800 patients, demonstrating potential to become a leading treatment for onychomycosis. Moberg Pharma has established commercial partnerships in several regions, including Europe and Canada. The company's shares are listed under Small Cap on Nasdaq Stockholm (OMX: MOB).

This announcement underscores Moberg Pharma's commitment to transparency and ongoing efforts to bring innovative treatments to market, with a focus on meeting regulatory standards and addressing unmet medical needs in onychomycosis.

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