Medicus Pharma optimizes clinical trial for 126 patients

• Medicus Pharma secured central IRB approval and written FDA feedback for its optimized Phase 2 clinical study.
• The company shares traded lower in the broader market following the clinical development announcement.
• The business stated that the regulatory clearances enable immediate study start-up and site activation activities.

Medicus Pharma (NASDAQ:MDCX) received central IRB approval and written FDA feedback for its optimized Phase 2 ANT-2111-02 clinical study.

The redesigned multicenter trial expects to enroll approximately 126 patients across the United States and Europe, compared to the roughly 390 participants outlined in the prior plan.

The randomized, double-blind, placebo-controlled clinical study will test both intramuscular and subcutaneous Teverelix regimens against a standard placebo.

The company stated that the recent FDA comments are strictly operational and will not affect the scientific rationale, treatment arms, or primary endpoint of the clinical trial.

Central IRB Advarra officially approved the medical protocol.

The clinical study focuses on treating men who are recovering from a first episode of acute urinary retention secondary to benign prostatic hyperplasia.

The business stated that the current regulatory approval remains valid through June 18, 2027, allowing for the comprehensive execution of necessary site activation activities.