Medicus Pharma (NASDAQ:MDCX) announced on Monday that it has submitted an optimized Phase 2 clinical study protocol to the US Food and Drug Administration (FDA) for Teverelix, an investigational GnRH antagonist.
The study is designed to evaluate the drug's effectiveness in preventing recurrent acute urinary retention (AURr) in men with benign prostatic hyperplasia (BPH) as part of an existing open Investigational New Drug application.
According to the company, this refined approach addresses a clinical need in a market Medicus estimates at $2 billion.
The updated study design, led by Principal Investigator Dr Steven Kaplan of the Icahn School of Medicine at Mount Sinai, focuses on capital efficiency and an accelerated development timeline.
The protocol features a targeted sample size of approximately 126 patients across the United States and Europe, which is a three-fold reduction compared to the original design. This modification is intended to reduce overall development costs and facilitate earlier strategic engagement and potential partnering opportunities.
The trial is structured as a randomized, double-blind, single-dose, four-arm study lasting 52 weeks. Participants will receive either a 90 mg intramuscular dose of Teverelix, a 120 mg subcutaneous dose of Teverelix, or matched placebo controls, while remaining on standard-of-care alpha-blocker therapy. The duration includes a 28-week treatment period followed by a 24-week follow-up phase.
The primary objective of the study is to measure the percent change in total prostate volume at Week 12.
Secondary endpoints include the maximum urine flow rate, post-void residual volume, and the recurrence of AUR.
An interim analysis is scheduled once 50% of the patients reach the Week 12 mark to inform future dose selection and Phase 3 study design.
“This refined study design reflects a more capital-efficient development strategy intended to accelerate Teverelix’s path to commercialization,” Medicus CEO Dr Raza Bokhari said.
“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.”
Currently, there are no approved pharmacologic therapies specifically indicated to prevent the recurrence of acute urinary retention.
Shares of Medicus added over 11% on Monday morning on the NASDAQ.