Medicus Pharma has submitted an optimised phase-II clinical study design to the US Food and Drug Administration (FDA) for Teverelix, its investigational GnRH antagonist, for the prevention of recurrent Acute Urinary Retention (AURr) in men with Benign Prostatic Hyperplasia (BPH) as part of its existing open Investigational New Drug (IND) for Teverelix.

The phase-II study design has been refined under the leadership of Steven A. Kaplan, MD, FACS, a globally recognised leader in urology and men’s health, who will serve as Principal Investigator.

Dr. Kaplan is Professor of Urology at the Icahn School of Medicine, Mount Sinai and has held senior academic appointments at Columbia University and Weill Cornell Medical College, where he served as Vice Chairman of Urology.

“This refined study design reflects a more capital-efficient development strategy intended to accelerate Teverelix’s path to commercialisation. By focusing on clear pharmacodynamic endpoints and incorporating an interim analysis designed to inform subsequent clinical development, we believe Teverelix can generate actionable clinical data more rapidly, enabling earlier strategic engagement and potential partnering opportunities,” said Dr. Raza Bokhari, Executive Chairman and CEO, Medicus.

There are currently no approved pharmacologic therapies specifically indicated to prevent recurrence of AUR, primarily due to enlarged prostate. The company’s proof-of-concept study design to evaluate Teverelix in AURr represents a novel approach addressing an underserved clinical need, representing an approximately USD 2 billion target market.

The updated phase-II study design (ANT-2111-02) incorporates a targeted sample size of approximately 126 patients across the US and Europe; a design focused on detecting a clear pharmacodynamic signal (total prostate volume reduction) and a structure optimised for dose and route differentiation.

This design demonstrates a data-driven evolution towards generating decision-grade clinical evidence representing an approximately three-fold reduction in study size compared to the original design and a meaningful reduction in overall development cost, with corresponding improvements in development efficiency and execution speed, supporting earlier strategic engagement and partnering discussions. The study is designed to generate an early pharmacodynamic signal within approximately 12 weeks.

The optimised phase-II study is a randomised, double-blind, single-dose, four-arm design. Patients will be randomised to receive Teverelix 90 mg (intramuscular), Teverelix 120 mg (subcutaneous) and matched placebo controls

All patients will receive a single injection on day one. The duration of the study is 52 weeks, which includes a 28-week treatment period and a 24-week follow-up. The patients will remain on standard-of-care alpha-blocker therapy.

The study is anchored by a mechanism-driven primary endpoint of percent change in Total Prostate Volume (TPV) at Week 12. The secondary endpoints include maximum urine flow rate (“Qmax”), Post Void Residual (PVR) volume, AURr and need for intervention.

An interim analysis will be conducted after approximately 50 percent of patients have completed the week 12 assessment to inform dose selection, route optimisation and future phase-III study design. This interim analysis is expected to provide an early pharmacodynamic signal and support timely development decision.