Medicus Pharma CEO Dr Raza Bokhari joined Steve Darling from Proactive Medicus Pharma CEO Dr. Raza Bokhari joined Steve Darling from Proactive to discuss the company's receipt of written FDA feedback and central Institutional Review Board (IRB) approval, with modifications, for its optimized Phase 2 clinical trial evaluating Teverelix® in men following a first episode of acute urinary retention (AUR).

Bokhari said the randomized, double-blind, placebo-controlled, multicenter study, designated ANT-2111-02, will enroll approximately 126 patients to evaluate the effects of Teverelix DP, a long-acting GnRH antagonist, on prostate volume and urinary function after an initial episode of AUR.

The FDA provided seven recommendations related to protocol implementation, safety monitoring, and study documentation, including updates to contraception reporting, injection-site blinding, alpha-blocker therapy tracking, race data collection, and clarification of a secondary endpoint.

Importantly, Bokhari said the company believes the FDA's comments are operational in nature and can be addressed through protocol amendments without changing the study's scientific rationale, patient population, treatment arms, primary endpoint, or planned interim analysis.

Medicus is now working with its regulatory, clinical, and contract research partners to incorporate both the FDA and IRB recommendations, finalize participating clinical sites, and complete the remaining start-up activities ahead of patient enrollment.

Management believes the regulatory feedback represents another important milestone in advancing Teverelix as a potential treatment for men experiencing acute urinary retention associated with enlarged prostate disease.

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