Moberg Pharma adjusts phase 3 trial expectations after patient data

Moberg Pharma AB announced on September 13, 2024, that it has adjusted its expectations regarding the primary endpoint in its ongoing North American Phase 3 trial for MOB-015, a treatment for nail fungus. The company revealed that the number of patients achieving clinical cure in a blinded subset was lower than anticipated, prompting the need to inform the market. This trial, which involves 384 patients across 33 centers in the US and Canada, is crucial for the drug's registration and commercialization in the US. The study differs from previous trials conducted in Europe, as it employs a reduced dosage regimen. Patients in the North American trial receive eight weeks of daily treatment followed by weekly maintenance for 40 weeks, contrasting with the continuous daily dosing used in earlier studies. The primary treatment goal, complete cure, is defined by three parameters: clinical cure, negative fungal culture, and negative microscopy. However, the company has not disclosed information regarding the other parameters. Moberg Pharma emphasized the importance of maintaining the integrity of the study data, especially as ongoing treatments are still being administered. The company is working closely with its contract research organization (CRO) to expedite the process of compiling data for the upcoming topline results, which they hope to release before the end of the year. The lowered expectations regarding clinical cure raise concerns about the potential for commercialization in the US, highlighting the risks associated with the trial's outcomes. The CEO, Anna Ljung, reiterated the company's commitment to protecting the study's data integrity while navigating these challenges.