(RTTNews) - Medicus Pharma Ltd. (MDCX) announced that it has reveived written feedback from the FDA and central Institutional Review Board approval for its redesigned Phase 2 clinical study of Teverelix in men following a first episode of acute urinary retention. The regulatory and ethical milestones mark a significant step forward in advancing the company's development program.
Acute urinary retention (AUR) is a serious complication often associated with benign prostatic hyperplasia, causing sudden inability to urinate and requiring immediate medical intervention. Current treatment options remain limited, underscoring the need for novel therapies.
The study, designated ANT-2111-02, is a randomized, double-blind, placebo-controlled, multicenter trial designed to evaluate the pharmacodynamic effects of Teverelix DP, a long-acting gonadotropin-releasing hormone (GnRH) antagonist, on prostate volume and urinary function. The optimized protocol reduces anticipated enrolment from about 390 patients to approximately 126, making the program more capital-efficient while still generating decision-grade clinical evidence.
Dr. Raza Bokhari, Executive Chairman and CEO of Medicus, said: "FDA's positive feedback and central IRB approval represent meaningful progress toward advancing our Teverelix Program. By redesigning this study, we believe we have transformed the development program into a substantially more efficient clinical strategy while preserving our ability to generate robust data."
Medicus emphasized that the streamlined study design is expected to accelerate clinical development, optimize capital allocation, and support future FDA interactions, late-stage trials, and potential strategic partnerships.
MDCX has traded between $0.25 and $3.35 over the past year. The stock closed Wednesday's trading at $0.34, down 4.23%. In pre-market trading the stock is at $0.36, up 5.40%.
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