Medicus Pharma (NASDAQ:MDCX) earlier this week outlined progress in the development of its investigational therapy Teverelix, confirming that it has submitted an optimized Phase 2 study design to the US Food and Drug Administration targeting acute urinary retention (AUR) relapse prevention.
Speaking to Proactive, chief medical officer Dr Faisal Mehmud said the company is refining its clinical approach to improve both efficiency and speed of decision-making. Mehmud explained that the updated study design shifts from a larger, later-stage data model to a more streamlined and mechanistic-driven approach, allowing earlier insights into the drug’s effectiveness.
The revised trial will enrol approximately 126 patients, significantly reduced from the previously planned 390, and will include an interim analysis at the halfway point. According to Mehmud, this enables “much earlier data-driven decisions” while maintaining robust evaluation criteria.
A key focus of the trial is a pharmacodynamic endpoint measuring prostate volume reduction at 12 weeks, which Mehmud described as providing “a very early and objective readout of the drug effect.” The study will also assess optimal dosing strategies and compare intramuscular versus subcutaneous administration routes.
Teverelix, a novel GnRH antagonist, is being developed for multiple men’s health indications. In this instance, the company is targeting AUR, a condition associated with enlarged prostate for which no pharmacological treatments are currently approved. This represents a potential unmet medical need and a key opportunity for the company.
Mehmud highlighted that prior Phase 2 data already demonstrated promising biological activity, including prostate volume reduction of more than 10% within four weeks, alongside improvements in urinary symptoms. He indicated that the current study aims to translate those findings into the AUR setting while further optimizing treatment delivery.