Medicus Pharma submits Teverelix Phase 2b/3 registrational protocol to FDA for review
MDCX•Medicus Pharma submitted an optimized, seamless Phase 2b/3 protocol for Teverelix in advanced prostate cancer to the FDA. The plan starts with about 80 randomized patients and could expand to about 608 if continuation criteria are met; Medicus plans to seek a partner to fund execution, pending FDA feedback.
1. Proposed trial design
The stage-gated protocol targets a registrational pathway in patients with advanced prostate cancer at increased cardiovascular risk. Medicus said the plan aims to reduce prior enrollment plans from about 1,500 patients to about 608 if continuation criteria are met, following an initial group of about 80 randomized patients. The company plans to seek a partner to fund execution, pending FDA feedback.
