PHILADELPHIA, PA — Medicus Pharma Ltd. (NASDAQ: MDCX) received authorization from Abu Dhabi health regulators to proceed with a Phase 2a trial of Teverelix in women with symptomatic endometriosis, advancing a precision-medicine strategy that will pair treatment response data with genomic analysis.
The United Arab Emirates Department of Health completed its review of the company’s manufacturing, nonclinical, clinical and safety documentation and approved the PRECISION-E2 study to proceed, according to Medicus.
The authorization remains subject to site-specific Institutional Review Board and ethics approvals before patient enrollment can begin.
The randomized, placebo-controlled trial is designed to enroll approximately 84 women with moderate-to-severe symptomatic endometriosis at multiple sites in the UAE. Participants will be assigned equally to three Teverelix regimens or placebo.
The treatment groups will receive a 60-milligram subcutaneous dose, a 90-milligram subcutaneous dose or a 90-milligram intramuscular dose. The placebo group will receive a subcutaneous injection.
The study’s primary endpoint will measure the proportion of participants who achieve and maintain serum estradiol levels of approximately 20 to 50 picograms per milliliter for at least 14 consecutive days after treatment.
Medicus will also assess pharmacokinetics, hormonal and bone-turnover biomarkers, safety, immunogenicity, endometriosis-related pain and quality-of-life outcomes.
The trial will prospectively combine those results with genomic information to explore whether predefined genes and biological pathways are associated with estradiol suppression, clinical benefit or treatment tolerability.
Genes identified for exploratory analysis include ESR1, ESR2, CYP19A1, GNRHR, FSHR and LHCGR, which are associated with estrogen signaling and metabolism, gonadotropin activity, inflammation and pain perception.
Any biomarker or multi-gene response signature identified through the study would require confirmation in later clinical trials before it could be used to select patients for treatment, the company noted.
Teverelix is an investigational long-acting gonadotropin-releasing hormone antagonist. Medicus is evaluating whether the drug can suppress estradiol rapidly and consistently while limiting the adverse effects associated with excessive estrogen reduction.
Executive Chairman and Chief Executive Officer Raza Bokhari characterized the regulatory clearance as support for a development strategy combining endocrinology, pharmacology and population genomics within a prospective trial.
“We believe PRECISION-E2 has the potential not only to optimize the future development of Teverelix but also is an important step toward personalized therapy,” Bokhari stated.
Endometriosis is a chronic, estrogen-dependent inflammatory disease associated with pelvic pain, infertility and impaired quality of life. Medicus estimates it affects about one in 10 women of reproductive age worldwide.
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