공고 • Jul 16
Medicus Pharma Ltd Receives Positive FDA Feedback and Central IRB Approval for Optimized Phase 2 Teverelix® Novel Study in Acute Urinary Retention
Medicus Pharma Ltd. had received written feedback from the U.S. Food and Drug Administration and central Institutional Review Board approval, with modifications, for its optimized Phase 2 clinical study of Teverelix in men following a first episode of acute urinary retention. The randomized, double-blind, placebo-controlled, multicenter study, designated ANT-2111-02, is a novel study designed to evaluate the pharmacodynamic effects of Teverelix DP, a long-acting gonadotropin-releasing hormone antagonist, on prostate volume and urinary function in men following a first episode of acute urinary retention. The Company submitted the optimized protocol to the FDA on April 2, 2026, under its existing Investigational New Drug application for Teverelix. The redesigned study is expected to enroll approximately 126 patients across the United States and Europe, compared with approximately 390 patients contemplated under the Company's previously disclosed development plan, and is intended to generate an early pharmacodynamic signal while supporting dose optimization, route selection and future clinical development. In its written response dated July 8, 2026, the FDA provided seven comments and recommendations concerning protocol implementation, safety monitoring and protocol clarification. The recommendations include: Aligning contraception and pregnancy reporting requirements with the one-year study duration; Maintaining blinding for injection-site assessments; Documenting changes in concomitant alpha-blocker therapy; Collecting subjects' race in addition to age and ethnicity; Clarifying investigator discretion in evaluating injection-site induration; and Revising the wording of a secondary composite endpoint to ensure that its component criteria are interpreted as intended. The Company believes the FDA's recommendations are operational in nature, readily addressable through targeted protocol and study-document amendments, and do not require changes to the study's scientific rationale, patient population, treatment arms, primary endpoint or planned interim analysis. Medicus intends to incorporate the FDA's recommendations into the protocol and related study documentation as it advances toward study initiation. Advarra, the study's Central IRB, approved the ANT-2111-02 protocol with modifications on June 18, 2026, with the approval period extending through June 18, 2027. Approved documentation includes the clinical protocol, informed consent forms, the Teverelix Investigator's Brochure, patient recruitment materials and patient-reported outcome instruments. The requested IRB modifications relate to the informed consent templates. The Central IRB approval applies to the study protocol. Each participating principal investigator and clinical site must complete site-specific submissions and receive local authorization before initiating patient enrollment. ANT-2111-02 is a randomized, double-blind, placebo-controlled, multicenter Phase 2 clinical study evaluating Teverelix for the prevention of recurrent acute urinary retention in men following a first episode of acute urinary retention secondary to benign prostatic hyperplasia. The optimized Phase 2 study is expected to enroll approximately 126 patients—approximately one-third of the enrollment contemplated under the Company's previously disclosed development plan—and will evaluate optimized intramuscular and subcutaneous Teverelix regimens versus matched placebo controls in men following a first episode of acute urinary retention secondary to benign prostatic hyperplasia. The study incorporates: A mechanism-driven primary endpoint evaluating reduction in total prostate volume; Prospective evaluation of recurrent acute urinary retention; Assessment of urinary function, including maximum urinary flow rate (Qmax) and post-void residual volume (PVR); Protocol-defined treatment failure and need for BPH-related medical or surgical intervention; Comprehensive pharmacodynamic, endocrine and safety assessments; Longitudinal evaluation of durability of treatment effect; and A pre-specified interim analysis designed to optimize dose selection, route of administration and subsequent clinical development. The Company is working with its regulatory, clinical and contract-research partners to incorporate the FDA and IRB comments, finalize participating clinical sites and complete the remaining study-start-up activities. Following incorporation of the FDA recommendations and completion of study start-up activities, the Company intends to continue progressing site activation while continuing discussions with FDA regarding opportunities to further optimize the overall clinical development and potential registrational strategy for the program. Medicus expects to provide additional guidance regarding study activation and anticipated enrollment timing following completion of these activities. The optimized ANT-2111-02 study builds upon clinical experience from more than 400 patients previously treated with Teverelix across multiple clinical studies and reflects extensive scientific, clinical and regulatory evaluation undertaken by the Company together with internationally recognized experts in urology, clinical development and regulatory science. Acute urinary retention is the sudden inability to urinate and is among the most serious complications of benign prostatic hyperplasia and is considered a medical emergency frequently results in emergency catheterization, recurrent healthcare utilization and progression to minimally invasive or surgical intervention. Although currently available medical therapies primarily manage lower urinary tract symptoms associated with BPH, there remains an important unmet medical need for therapies specifically intended to reduce recurrence following an initial episode of acute urinary retention. Medicus believes Teverelix has the potential to establish a new treatment paradigm by addressing one of the underlying biological drivers of recurrent AUR rather than simply managing its consequences. Teverelix is a next-generation, long-acting gonadotropin-releasing hormone antagonist being developed across multiple hormone-dependent indications, including recurrent acute urinary retention associated with benign prostatic hyperplasia, advanced prostate cancer in patients with elevated cardiovascular risk, and selected women's health indications.