PHILADELPHIA, PA — Medicus Pharma Ltd. (Nasdaq: MDCX) plans to test its Teverelix drug candidate in about 126 patients after receiving FDA feedback and central ethics approval for a redesigned Phase 2 trial, reducing projected enrollment by roughly two-thirds as the biotechnology company seeks a less capital-intensive development path.
The randomized study will evaluate whether Teverelix can reduce prostate volume, improve urinary function and prevent recurrent acute urinary retention in men following an initial episode linked to benign prostatic hyperplasia.
Medicus previously contemplated enrolling approximately 390 patients. The revised protocol is structured to produce an earlier pharmacodynamic signal while helping the company select a dose, determine whether to use intramuscular or subcutaneous administration and shape subsequent clinical development.
The U.S. Food and Drug Administration provided seven comments and recommendations in a July 8 written response covering safety monitoring, study implementation and protocol wording. Medicus submitted the revised protocol April 2 under its existing investigational new drug application.
The agency’s recommendations include aligning contraception and pregnancy-reporting requirements with the trial’s one-year duration, maintaining blinding during injection-site assessments and documenting changes in patients’ use of alpha-blocker medications.
The FDA also requested the collection of race data, clarification of how investigators should evaluate injection-site induration and revised wording for a secondary composite endpoint.
Medicus characterized the comments as operational and expects to address them through amendments to the protocol and supporting documents. The recommendations do not alter the planned patient population, treatment groups, primary endpoint or interim analysis, according to the company.
Advarra, the trial’s central institutional review board, approved the protocol with modifications June 18. The approval, which runs through June 18, 2027, covers the protocol, consent forms, investigator materials, recruitment documents and patient-reported outcome measures.
The requested modifications concern informed-consent templates. Individual investigators and clinical sites must still complete site-specific reviews and receive authorization before enrolling patients.
The study, designated ANT-2111-02, will compare optimized intramuscular and subcutaneous Teverelix regimens with matched placebos. Its primary endpoint will measure changes in total prostate volume.
Researchers will also track recurrent urinary retention, maximum urinary flow, post-void residual volume, treatment failure and the need for additional medical or surgical intervention. Pharmacodynamic, endocrine and safety measures will be assessed over time.
A pre-specified interim analysis is intended to guide dose selection, administration route and future development decisions before the trial is completed.
“By redesigning this study, we believe we have transformed the Teverelix development program into a substantially more efficient clinical strategy,” Executive Chairman and Chief Executive Officer Raza Bokhari stated, citing the reduction in anticipated enrollment from approximately 390 patients to 126.
The smaller study could lower development spending and produce data sooner, though Medicus has not disclosed a projected trial cost, activation date or enrollment schedule.
The company is incorporating the FDA and IRB comments, selecting clinical sites and completing other startup work in the United States and Europe. It expects to provide enrollment guidance after those preparations are finished.
Teverelix is a long-acting gonadotropin-releasing hormone antagonist. More than 400 patients have received the drug across previous clinical studies, according to Medicus.
The company is also evaluating Teverelix for advanced prostate cancer in patients with elevated cardiovascular risk and for selected women’s health indications.
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