Medicus Pharma Submits IND for First-of-Its-Kind Genomics-Enabled Phase 2a Trial of Teverelix in Endometriosis
核心洞察
Medicus Pharma submitted an IND application to Abu Dhabi's Department of Health for PRECISION-E2, a Phase 2a genomics-enabled trial of long-acting GnRH antagonist Teverelix in women with symptomatic endometriosis (搜索).
The randomized, placebo-controlled study will enroll approximately 84 participants in the UAE and evaluate three dosing regimens to identify optimal estradiol suppression within the "Barbieri Window."
PRECISION-E2 integrates with the Emirati Genome Program, creating what may become one of the most comprehensive precision medicine datasets ever assembled in endometriosis (搜索) research.
PHILADELPHIA — Medicus Pharma Ltd. (搜索) (NASDAQ: MDCX) announced on June 11, 2026, the submission of an Investigational New Drug (IND) application to the Department of Health, Abu Dhabi (DOH) for PRECISION-E2, a first-of-its-kind, Phase 2a genomics-enabled clinical trial evaluating Teverelix in women with symptomatic endometriosis (搜索) in the United Arab Emirates (UAE).
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 (搜索). The study will leverage participants enrolled in the Emirati Genome Program (EGP), 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 represents far more than a traditional endometriosis (搜索) clinical trial," said Dr. Raza Bokhari, Medicus Executive Chairman and CEO. "To our knowledge, this is among the first prospective studies evaluating a long-acting GnRH antagonist in endometriosis through a precision medicine framework. We believe this approach has the potential to help transform the management of endometriosis from a one-size-fits-all treatment paradigm toward a more personalized and data-driven model of care."
Study Design and Objectives
PRECISION-E2 (Precision Estradiol Suppression and Genomic Response Study in Endometriosis (搜索)) is a prospective, randomized, placebo-controlled Phase 2a clinical study. The trial will enroll approximately 84 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.
Genomics Integration
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 (搜索).
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 (TRE).
Disease Burden and Unmet Need
Endometriosis (搜索) 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.
About Teverelix
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 (AACE) 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 (搜索).
Future Development Pathway
The Company believes successful completion of PRECISION-E2 could support future Phase 2b development in endometriosis (搜索) 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.