공고 • Jul 31
Medicus Pharma Receives UAE Department Of Health Authorization To Proceed With Novel Prospective Genomics Guided Precision Medicine Study Evaluating Teverelix In Women With Endometriosis
Medicus Pharma Ltd. announced that the United Arab Emirates Department of Health – Abu Dhabi has granted Investigational New Drug authorization for the Company's PRECISION-E2 Phase 2a clinical study evaluating Teverelix in women with moderate-to-severe symptomatic endometriosis, a chronic estrogen-dependent inflammatory disease that affects approximately one in ten women of reproductive age worldwide. The authorization follows completion of the Department of Health's comprehensive scientific and regulatory review of the Company's chemistry, manufacturing and controls, non-clinical, clinical and safety documentation and approved the “Study to Proceed”, subject to completion of required site-specific Institutional Review Board and ethics approvals. The PRECISION-E2 study represents a significant regulatory milestone in Medicus' women's health strategy and advances the development of Teverelix into what the Company believes is one of the first prospective genomics-guided precision medicine development programs designed to identify women with moderate-to-severe endometriosis most likely to benefit from a long-acting GnRH antagonist. 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. Participants will be randomized equally among four treatment groups: Teverelix 60 mg administered subcutaneously, Teverelix 90 mg administered subcutaneously, Teverelix 90 mg administered intramuscularly, and placebo administered subcutaneously. The study's primary pharmacodynamic endpoint is the proportion of participants achieving and maintaining serum estradiol within the established Barbieri therapeutic window (approximately 20–50 pg/mL) for at least 14 consecutive days following treatment. Secondary and exploratory endpoints include pharmacokinetic parameters, hormonal biomarkers, bone turnover biomarkers, safety, immunogenicity, endometriosis-associated pain, quality-of-life assessments and exploratory genomic analyses. The Company intends to explore whether integration of these clinical, pharmacodynamic and genomic data can identify candidate treatment-response biomarkers associated with controlled estradiol suppression, clinically meaningful benefit and treatment tolerability. Any candidate biomarker or multi-gene treatment-response signature identified through PRECISION-E2 would require confirmation in subsequent clinical studies before being used to guide patient selection. Unlike conventional endometriosis clinical studies that primarily evaluate safety and efficacy, PRECISION-E2 has been specifically designed to prospectively integrate genomic information with endocrine pharmacology, pharmacokinetics, biomarkers, safety assessments and patient-reported outcomes to better understand why individual women respond differently to hormonal therapy. The study has been designed to integrate whole-genome information from participating women, subject to applicable approvals and governance requirements, hormonal pharmacodynamics including estradiol, luteinizing hormone and follicle-stimulating hormone, pharmacokinetic exposure, bone turnover biomarkers, clinical symptom improvement, patient-reported quality-of-life outcomes, safety and tolerability, and exploratory analyses of predefined genes and biological pathways associated with estrogen receptor signaling, estrogen synthesis and metabolism, gonadotropin signaling, endometriosis biology, inflammatory pathways and pain perception, including candidate genes such as ESR1, ESR2, CYP19A1, GNRHR, FSHR and LHCGR. The Company believes this integrated approach has the potential to generate one of the most comprehensive precision medicine datasets assembled in endometriosis and to establish an important scientific foundation for future biomarker-informed development of Teverelix. Endometriosis is a chronic estrogen-dependent inflammatory disease affecting approximately one in ten women of reproductive age worldwide. Beyond chronic pelvic pain, dysmenorrhea and infertility, the disease frequently affects education, employment, family planning, emotional wellbeing and long-term quality of life. Despite multiple available therapies, many women continue to experience inadequate symptom control, treatment-limiting adverse effects, recurrence following treatment discontinuation and variability in therapeutic response. PRECISION-E2 has been designed to evaluate whether Teverelix can achieve rapid, controlled and sustained estradiol suppression while minimizing unwanted hypoestrogenic effects and simultaneously generating the pharmacodynamic, clinical and genomic data necessary to optimize dose selection, route of administration and future precision medicine strategies. Teverelix is a next-generation, long-acting gonadotropin-releasing hormone antagonist being developed by Medicus Pharma through its subsidiary, Antev Ltd. Teverelix is designed to produce rapid and reversible suppression of reproductive hormones without the initial hormonal flare associated with GnRH agonists. Its injectable depot formulation is intended to provide sustained exposure and may support less-frequent dosing than currently available daily oral GnRH antagonists. Teverelix is being developed across several indications, including advanced prostate cancer in patients with elevated cardiovascular risk, recurrence of acute urinary retention associated with benign prostatic hyperplasia, and women’s health conditions including endometriosis.