Medicus advances Teverelix development with EU Phase 2b trial submission in Prostate Cancer
Medicus Pharma Chief Medical Officer Dr Faisal Mehmud joined Steve Darling from Proactive to discuss the company’s successful submission of a substantial modification application through the European Union Clinical Trials Information System (CTIS), supporting the planned Phase 2b study of Teverelix® in advanced prostate cancer. Mehmud said the submission marks an important step in advancing Teverelix® toward registrational development, with a particular focus on prostate cancer patients who have elevated cardiovascular risk and require androgen deprivation therapy (ADT). This patient population represents a significant unmet medical need, as cardiovascular complications remain a major consideration in treatment selection and long-term management. The planned Phase 2b study is designed to optimize dose selection and further evaluate the pharmacokinetic, pharmacodynamic, efficacy, and safety profile of Teverelix® ahead of later-stage development. The data generated will help guide future registrational studies and support regulatory discussions in both Europe and the United States. Medicus has already engaged extensively with the U.S. Food and Drug Administration regarding its advanced prostate cancer development strategy, including future clinical programs focused on patients with heightened cardiovascular risk. Subject to regulatory review and approval, the company expects to begin patient enrollment later this year. Results from the study are anticipated to play a key role in determining optimal dosing, refining pivotal trial design, and advancing interactions with global regulatory agencies. Management’s objective is to position Teverelix® as a best-in-class hormonal therapy specifically developed for advanced prostate cancer patients where cardiovascular safety is a critical treatment consideration. #proactiveinvestors #nasdaq #mdcx #tsxv #mdcx #pharma #ClinicalTrials #Phase2 #Teverelix #Biotech #DrugDevelopment #FDA #Urology #BPH #AUR #MensHealth #PharmaInnovation #Healthcare #MedicalResearch #Biopharma
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