PHILADELPHIA, PA — Medicus Pharma Ltd. (NASDAQ: MDCX) is moving toward activation of a redesigned Phase 2 Teverelix trial after receiving FDA feedback and central ethics approval, cutting planned enrollment by about two-thirds as the company seeks a faster and less capital-intensive development path.
The randomized study will enroll approximately 126 men in the United States and Europe following a first episode of acute urinary retention caused by benign prostatic hyperplasia. Medicus had previously contemplated enrolling about 390 patients.
Teverelix is a long-acting gonadotropin-releasing hormone antagonist. The trial will assess whether the drug can reduce prostate volume, improve urinary function and prevent recurrent urinary retention.
The FDA provided seven comments and recommendations in a July 8 written response. The agency requested revisions involving safety monitoring, contraception and pregnancy reporting, injection-site assessments, concomitant medication changes, demographic data collection and the wording of a secondary endpoint.
Medicus characterized the recommendations as operational and expects to address them through amendments to the protocol and related study documents. The comments do not require changes to the scientific rationale, patient population, treatment groups, primary endpoint or planned interim analysis, according to the company.
Advarra, the trial’s central institutional review board, approved the protocol with modifications on June 18. The approval extends through June 18, 2027, with requested changes focused on informed-consent templates.
Each principal investigator and participating clinical site must still complete site-specific submissions and receive authorization before enrolling patients.
The study, designated ANT-2111-02, will compare intramuscular and subcutaneous Teverelix regimens with matched placebos. Its primary endpoint will measure changes in total prostate volume.
Investigators will also track recurrent acute urinary retention, maximum urinary flow, post-void residual volume, treatment failure and the need for additional medical or surgical intervention. The protocol includes endocrine, pharmacodynamic and safety assessments as well as a prespecified interim analysis to guide dose and administration-route selection.
Executive Chairman and Chief Executive Officer Raza Bokhari described the revised protocol as a more efficient strategy that could reduce development costs while preserving the company’s ability to generate evidence for future regulatory discussions.
“We believe we have transformed the Teverelix development program into a substantially more efficient clinical strategy, reducing anticipated enrollment from approximately 390 patients to approximately 126 patients,” Bokhari stated.
Medicus is working with clinical, regulatory and contract-research partners to incorporate the FDA and institutional review board comments, finalize trial sites and complete startup activities.
The company has not yet provided a study activation date or enrollment timeline. Additional guidance is expected after the remaining startup work is completed.
More than 400 patients have previously received Teverelix across multiple clinical studies, according to Medicus.
Acute urinary retention is a sudden inability to urinate and often requires emergency catheterization. In men with benign prostatic hyperplasia, an initial episode can lead to recurrent treatment, additional healthcare use and surgical intervention.
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