Medicus Pharma Advances Teverelix Into Streamlined Phase 2b/3 Design

(RTTNews) - Medicus Pharma (MDCX), on Tuesday, said it submitted a streamlined Phase 2b/3 registration-intent protocol to the U.S. Food and Drug Administration (FDA) for Teverelix in advanced prostate cancer patients at increased cardiovascular risk.

Advanced prostate cancer is cancer that has spread beyond the prostate and may require treatments that reduce testosterone levels to slow disease progression.

Teverelix is a long-acting gonadotropin-releasing hormone (GnRH) antagonist being developed for advanced prostate cancer, with the program focused on testosterone suppression and cardiovascular evaluation.

The proposed seamless Phase 2b/3 study would initially enroll about 80 randomized patients, replacing a previously FDA-cleared standalone 40-patient open-label dose-optimization study.

If predefined continuation criteria are met, the trial would add approximately 528 patients, bringing total enrollment to about 608 patients. Patients from the first stage who meet eligibility requirements would contribute to the final registration analyses.

Medicus said the single-pathway design combines dose optimization, androgen suppression and cardiovascular evaluation, potentially reducing the planned clinical program by about 60%, from approximately 1,500 patients to about 600.

The proposed trial includes a 12-month coronary non-calcified plaque endpoint measured by coronary CT angiography, while longer-term cardiovascular event follow-up would continue in the same patients.

Following FDA feedback, Medicus intends to seek an out-license or other strategic partnership for the Teverelix prostate cancer program rather than fund the study itself.

MDCX closed Monday's trade at $0.15, down 0.20%.

In the pre-market trade shares are up at $0.15, up 0.20%.