PHILADELPHIA, PA — Medicus Pharma Ltd. (Nasdaq: MDCX) said it has submitted an optimized Phase 2 clinical trial protocol to the U.S. Food and Drug Administration for teverelix, an investigational treatment aimed at preventing recurrent acute urinary retention in men with benign prostatic hyperplasia.
The company said the study is being conducted under its existing Investigational New Drug application and is designed to evaluate teverelix, a GnRH antagonist, in a condition for which no pharmacologic therapies are currently approved.
The Phase 2 trial will enroll approximately 126 patients across the United States and Europe and is structured as a randomized, double-blind, four-arm study.
Participants will receive either a 90 mg intramuscular dose, a 120 mg subcutaneous dose, or matched placebo, alongside standard-of-care alpha-blocker therapy.
The primary endpoint will measure the percent change in total prostate volume at 12 weeks, with secondary endpoints including urine flow rate, post-void residual volume, recurrence of urinary retention, and need for intervention.
The study will run for 52 weeks, including a 28-week treatment period and a 24-week follow-up.
An interim analysis is planned after about half of participants complete the 12-week assessment to inform dose selection and future Phase 3 trial design.
Steven A. Kaplan, a professor of urology at the Icahn School of Medicine at Mount Sinai, will serve as principal investigator.
Medicus said the revised protocol reduces the study size by about threefold compared with its original design and is intended to lower development costs and accelerate timelines.
The company estimates the target market for therapies addressing recurrent acute urinary retention at approximately $2 billion.
Teverelix is also being developed for advanced prostate cancer patients at high cardiovascular risk.
Medicus said it is pursuing additional development programs, including its SkinJect platform for non-melanoma skin diseases and collaborations related to mRNA technology, patient access initiatives, and artificial intelligence-driven clinical development tools.
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