공시 • Jun 11
Medicus Pharma Submits Ind Application for PRECISION-E2 Phase 2A Study of Teverelix in Endometriosis in United Arab Emirates
Medicus Pharma Ltd. submitted an Investigational New Drug (IND) application to the Department of Health, Abu Dhabi for PRECISION-E2, a first-of-its-kind, Phase 2a genomics-enabled clinical trial evaluating Teverelix in women with symptomatic endometriosis in the United Arab Emirates. The PRECISION-E2 study is designed to combine clinical outcomes, hormonal biomarkers, pharmacokinetic and pharmacodynamic measurements, and genomic analyses to better understand treatment response variability in women suffering from endometriosis. The study will leverage participants enrolled in the Emirati Genome Program, one of the world's largest national genomics initiatives, creating a unique opportunity to explore how genetic variation may influence response to hormonal therapy. 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 genomic correlates of Teverelix in women with moderate-to-severe symptomatic endometriosis. The study will enroll approximately 84 participants in the UAE and incorporates genomic analyses utilizing participants enrolled in the Emirati Genome Program. The Study will enroll participants across multiple investigational sites in the UAE and will evaluate three Teverelix treatment regimens, including both subcutaneous and intramuscular administration, with the objective of identifying an optimal dose and route of administration capable of achieving controlled estradiol suppression while maintaining a favorable safety profile. The study is designed to evaluate whether Teverelix can achieve controlled estradiol suppression within the established therapeutic "Barbieri Window" while minimizing unwanted hypoestrogenic effects such as vasomotor symptoms and bone loss. In addition to clinical symptom assessments and quality-of-life measurements, investigators will evaluate bone turnover biomarkers, hormonal response, pharmacokinetics, immunogenicity, and genomic correlates of treatment response. A distinguishing feature of the study is its integration with the Emirati Genome Program. Researchers will explore genetic variation within estrogen-signaling and gonadotropin pathways and evaluate potential associations with hormonal response, symptom improvement, safety outcomes, and overall treatment effectiveness. The resulting dataset will combine genomic information with clinical, pharmacodynamic, pharmacokinetic, and patient-reported outcomes, potentially creating one of the most comprehensive precision medicine datasets ever assembled in endometriosis. The study also includes a prospective precision medicine component designed to explore how genomic and phenotypic factors may influence treatment response and disease biology. Subject to applicable approvals and governance requirements, the program may leverage elements of Abu Dhabi’s advanced health data infrastructure, including the Emirati Genome Program, Malaffi and the Trusted Research Environment. Endometriosis is a chronic estrogen-dependent inflammatory disease affecting approximately one in ten women of reproductive age worldwide. The disease is associated with debilitating pelvic pain, dysmenorrhea, infertility, and significantly impaired quality of life. Despite multiple approved therapies, many women continue to experience inadequate symptom control, treatment-limiting side effects, recurrence of symptoms, and challenges associated with long-term treatment adherence. The Company believes successful completion of PRECISION-E2 could support future Phase 2b development in endometriosis while potentially informing additional women's health indications, including uterine fibroids and other estrogen-driven disorders. Furthermore, the genomic findings generated through the study may contribute to the development of future precision medicine approaches aimed at identifying patients most likely to benefit from targeted hormonal therapies. Teverelix is a novel long-acting GnRH antagonist being developed by Medicus Pharma through its subsidiary Antev Ltd. The program is currently being evaluated across multiple indications, including advanced prostate cancer, acute urinary retention associated with benign prostatic hyperplasia, and women's health disorders. Teverelix produces rapid and reversible suppression of reproductive hormones without the initial hormonal flare. Prior clinical studies, presented in a poster presentation at the American Academy of Clinical Endocrinology annual meeting in April 2026, have demonstrated dose-dependent hormonal suppression and a favorable safety profile, supporting evaluation in estrogen-dependent conditions such as endometriosis.