Medicus Pharma (NASDAQ:MDCX) has filed a substantial modification application through the European Union Clinical Trials Information System to advance a Phase 2b study of its prostate cancer treatment Teverelix, the company said on Monday.
The planned trial will focus on patients with advanced prostate cancer and elevated cardiovascular risk who require androgen deprivation therapy (ADT), a segment the company estimates represents roughly $4 billion in annual market opportunity across major pharmaceutical markets.
Teverelix is a long-acting injectable hormone therapy designed to rapidly suppress testosterone levels without causing the hormonal flare seen with older prostate cancer treatments.
Medicus said it believes the drug's profile may offer advantages over traditional GnRH agonists in patients where cardiovascular outcomes are a concern.
No hormonal therapy currently carries a regulatory label specifically addressing treatment of high cardiovascular-risk prostate cancer patients, the company noted.
The Phase 2b study is designed to optimize dose selection and characterize the drug's pharmacokinetic, pharmacodynamic, efficacy and safety profile ahead of registrational development. Medicus said it has previously engaged with the US Food and Drug Administration on its development strategy.
Subject to regulatory review, the company intends to begin patient enrollment later this year.