PHILADELPHIA, PA — Medicus Pharma Ltd. (NASDAQ: MDCX) has proposed a redesigned late-stage development program for its prostate cancer drug Teverelix that could reduce planned enrollment by about 60% while positioning the asset for licensing rather than requiring the company to finance another clinical study itself.
The company submitted an optimized seamless Phase 2b/3 registration-intent protocol to the U.S. Food and Drug Administration for Teverelix in advanced prostate cancer patients at increased cardiovascular risk.
Under the proposal, Medicus would begin with about 80 randomized patients for dose optimization, replacing a previously cleared stand-alone 40-patient open-label Phase 2b study. If predefined continuation criteria are met, approximately 528 additional patients would be enrolled, bringing total enrollment to about 608.
Eligible patients from the initial stage would contribute to the final registration analyses, eliminating the need to conduct separate dose-optimization and Phase 3 studies.
The design could reduce enrollment from a previously contemplated program of roughly 1,500 patients to about 600, cutting duplication, development time and capital requirements. The FDA has not agreed to the proposed pathway.
Medicus intends to use the agency’s feedback to determine whether it can establish a registrational strategy attractive to a pharmaceutical partner. Rather than independently financing the proposed trial, the company plans to pursue an out-license or other strategic transaction under which a partner would fund subsequent development and commercialization.
“Our objective with this submission is not to commit Medicus capital to another APC clinical study — it is to define the most efficient registrational pathway possible and make Teverelix ready for a strategic partner,” Executive Chairman and Chief Executive Officer Raza Bokhari said.
The strategy follows Medicus’ September decision to concentrate its capital and organizational resources on programs it considers to have stronger risk-adjusted opportunities.
The FDA in February gave “Study May Proceed” clearance for the earlier 40-patient Phase 2b study, which was designed to confirm dosing and sustained testosterone suppression. Medicus subsequently developed the larger seamless protocol while continuing manufacturing, quality-release and other clinical-readiness work expected to be completed by year-end.
The new protocol would assess both androgen suppression and potential cardiovascular differentiation. It incorporates a 12-month coronary non-calcified plaque endpoint measured through coronary CT angiography, with standardized baseline and 12-month scans and blinded central analysis.
Medicus based that component of the proposed design on randomized clinical evidence published in JAMA Cardiology in 2026 indicating that differences in coronary plaque progression between gonadotropin-releasing hormone treatment pathways can be measured over 12 months using non-invasive coronary CT angiography.
Longer-term cardiovascular event follow-up could continue in the same patients.
The approach is intended to determine whether Teverelix can provide effective androgen deprivation while demonstrating cardiovascular differentiation in advanced prostate cancer patients already at elevated cardiovascular risk.
FDA agreement remains necessary before Medicus can rely on the proposed design as a potential registration pathway. The company also cautioned that regulatory acceptance would not guarantee successful development, approval or a licensing transaction.
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