Medicus Pharma files Abu Dhabi regulatory application for endometriosis trial
Medicus Pharma (NASDAQ:MDCX) submitted an Investigational New Drug (IND) application to the Department of Health, Abu Dhabi, seeking authorization to launch a genomics-enabled Phase 2a clinical trial evaluating its candidate Teverelix in women with symptomatic endometriosis.
The Philadelphia-based, clinical-stage biopharmaceutical company confirmed that the trial, titled PRECISION-E2, will be conducted in the United Arab Emirates.
The study marks a notable integration of regional precision medicine infrastructure, as it is designed to leverage patient data from the Emirati Genome Program—one of the world's largest national population genomics initiatives—to explore how specific genetic variations influence patient responses to targeted hormonal therapies.
Endometriosis is an estrogen-driven, inflammatory condition affecting approximately one in ten women of reproductive age globally, causing chronic pelvic pain, severe dysmenorrhea, and infertility.
Medicus's candidate, Teverelix, is a long-acting gonadotropin-releasing hormone (GnRH) antagonist.
The upcoming Phase 2a trial aims to evaluate whether the therapy can safely achieve controlled estradiol suppression within a tight therapeutic window, alleviating severe physical symptoms while minimizing the adverse bone mineral density loss and vasomotor side effects typically linked to systemic estrogen deprivation.
The prospective, randomized, placebo-controlled study targets an enrollment of approximately 84 participants within the UAE.
Investigators will monitor clinical outcomes, pharmacokinetics, and hormonal biomarkers alongside genomic sequencing profiles to establish correlations between pathways and overall patient safety and efficacy outcomes.
