teverelix DP / Medicus Pharma - LARVOL DELTA

Study of Teverelix DP on Prostate Volume, Urinary Function and Clinical Outcomes Following Acute Urinary Retention (clinicaltrials.gov) - P2 | N=126 | Not yet recruiting | Sponsor: Antev Ltd.

New P2 trial • Benign Prostatic Hyperplasia

Medicus Pharma…announced that it has submitted an optimized seamless Phase 2b/3 registration-intent protocol to the U.S. Food and Drug Administration ('FDA') for Teverelix, its investigational, next generation, long-acting GnRH antagonist, in advanced prostate cancer ('APC') patients at increased cardiovascular ('CV') risk (GlobeNewswire) - "Importantly, the proposed design is stage-gated: it begins with approximately 80 randomized patients, incorporating and replacing the previously FDA-cleared stand-alone 40-patient open-label Phase 2b dose-optimization study. Once predefined continuation criteria have been satisfied, the program would then proceed to add approximately 528 patients, for approximately 608 patients in total, with eligible patients from the initial stage contributing to the final registration analyses....If the FDA agrees with the proposed approach, Medicus believes the optimized design could reduce the overall planned clinical development program from approximately 1,500 patients to approximately 600 patient..."

Clinical protocol • New P2/3 trial • Prostate Cancer

Medicus Pharma…announced that the United Arab Emirates (UAE) Department of Health - Abu Dhabi ('DOH') has granted Investigational New Drug ('IND') authorization for the Company’s PRECISION-E2 Phase 2a clinical study evaluating Teverelix in women with moderate-to-severe symptomatic endometriosis (Medicus Pharma Press Release) - "The authorization follows completion of the DOH’s comprehensive scientific and regulatory review of the Company’s chemistry, manufacturing and controls (CMC), non-clinical, clinical and safety documentation and approved the 'Study to Proceed', subject to completion of required site-specific Institutional Review Board ('IRB') and ethics approvals....PRECISION-E2 (Precision Estradiol Suppression and Genomic Response Study in Endometriosis) is a prospective, randomized, placebo-controlled Phase 2a clinical study designed to evaluate the pharmacodynamics, safety, tolerability, clinical activity and exploratory genomic correlates of Teverelix in approximately 84 women with moderate-to-severe symptomatic endometriosis across multiple investigational sites in the United Arab Emirates."

New P2a trial • Endometriosis

Medicus Pharma files IND for genomics-enabled endometriosis trial in UAE (Proactiveinvestors) - "Medicus Pharma...has submitted an Investigational New Drug application to Abu Dhabi's Department of Health for PRECISION-E2, a Phase 2a clinical trial evaluating its Teverelix drug candidate in women with symptomatic endometriosis in the United Arab Emirates....The study will enroll approximately 84 women across multiple sites in the UAE and test three different Teverelix dosing regimens, delivered by injection, to determine which dose and method best controls estrogen levels while minimizing side effects."

New P2a trial • Endometriosis

Medicus Pharma Ltd…announced the 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 (APC). (GlobeNewswire) - "The planned Phase 2b study is designed to optimize dose selection and further characterize the pharmacokinetic, pharmacodynamic, efficacy and safety profile of Teverelix ahead of planned registrational development."

New P2b trial • Prostate Cancer