PHILADELPHIA, PA — Medicus Pharma Ltd. (Nasdaq: MDCX) recently submitted an updated Phase 2 clinical study design 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 submission is part of the company’s existing Investigational New Drug application and reflects revisions intended to refine study endpoints and reduce development costs.
The Phase 2 study will enroll approximately 126 patients across the United States and Europe and is designed to evaluate changes in total prostate volume as the primary endpoint.
Participants will be randomized into four groups to receive either a 90 mg intramuscular dose of Teverelix, a 120 mg subcutaneous dose, or matched placebo controls.
All patients will receive a single injection at the start of the study and remain on standard alpha-blocker therapy, with a total study duration of 52 weeks, including treatment and follow-up periods.
Secondary endpoints include urine flow rate, post-void residual volume, recurrence of urinary retention, and need for intervention.
An interim analysis will be conducted after about half of participants complete a 12-week assessment to guide dose selection and inform potential Phase 3 development.
Steven A. Kaplan, a urologist and professor at the Icahn School of Medicine at Mount Sinai, will serve as principal investigator for the study.
Chief Executive Officer Dr. Raza Bokhari said the revised design is intended to generate clinical data more efficiently and support future development decisions.
“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,” Bokhari said.
There are currently no approved drug therapies specifically indicated to prevent recurrence of acute urinary retention, a condition commonly associated with enlarged prostate.
Medicus said the study is designed to generate an early signal of treatment effect within approximately 12 weeks.
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