PHILADELPHIA, PA — Medicus Pharma Ltd. is seeking U.S. Food and Drug Administration approval for a redesigned late-stage development plan that could cut enrollment in its Teverelix advanced prostate cancer program by about 60% while positioning the experimental therapy for licensing to a pharmaceutical partner rather than further development funded by Medicus.
The Nasdaq-listed biotechnology company submitted a seamless Phase 2b/3 registration-intent protocol covering about 608 patients with advanced prostate cancer who are at increased cardiovascular risk. The proposal would replace a previously cleared standalone dose-optimization study and a larger sequential development program that Medicus said could have required about 1,500 patients.
The strategy reflects a broader effort by Medicus to limit its own capital exposure while establishing a regulatory pathway that another company could finance and execute.
“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.
Under the proposal, Medicus would begin with about 80 randomized patients in a dose-optimization stage. If predefined continuation criteria are met, the study would add about 528 patients, while eligible participants from the initial stage would be included in the final registration analyses.
That structure would replace a 40-patient, open-label Phase 2b dose-optimization study that received FDA “Study May Proceed” clearance in February. The earlier trial was designed to establish dosing and sustained testosterone suppression.
Medicus said the seamless design could eliminate the need to conduct the smaller trial separately before proceeding to a substantially larger Phase 3 program, potentially reducing duplication, development time and capital requirements.
The company has not committed to conducting the proposed 608-patient study itself. After receiving FDA feedback, Medicus intends to pursue an out-licensing agreement or other strategic partnership under which another pharmaceutical company would fund subsequent clinical development and commercialization.
There is no assurance the FDA will accept the proposed protocol or agree that the development plan could support registration. Medicus also cautioned that it may not secure a licensing or strategic transaction for Teverelix.
The proposed trial would assess both androgen suppression and potential cardiovascular differentiation, targeting advanced prostate cancer patients who already face elevated cardiovascular risk.
Medicus plans to incorporate a 12-month coronary non-calcified plaque endpoint measured using coronary CT angiography, or CCTA, alongside testosterone-suppression requirements. Longer-term cardiovascular events could continue to be tracked in the same patients.
The company said the approach draws in part on randomized clinical evidence published in JAMA Cardiology this year indicating that differences in coronary plaque progression between gonadotropin-releasing hormone treatment pathways can be measured over 12 months using CCTA.
Teverelix is an investigational long-acting GnRH antagonist formulated as a microcrystalline suspension. The drug is intended to suppress hormones without the initial testosterone surge associated with GnRH agonists.
Medicus is also working on manufacturing, quality-release and other clinical-readiness preparations that it expects to complete before year-end.
The regulatory proposal follows a portfolio strategy Medicus outlined in September that calls for concentrating its capital and organizational resources on clinical programs it views as offering stronger risk-adjusted opportunities. For Teverelix in advanced prostate cancer, the immediate objective is to define the regulatory pathway before committing additional internal capital to clinical execution.
Any subsequent development timetable will depend on the FDA’s response, financing or partnership arrangements, enrollment, clinical results and further regulatory review.
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