Medicus Pharma Initiates PRECISION-E2 Phase 2a Study of Teverelix in Endometriosis Using Emirati Genome Program

An IND submission to Abu Dhabi's Department of Health signals a shift in how genomics-enabled trial design is entering hormonal therapy development: Medicus Pharma has filed for PRECISION-E2, a Phase 2a study evaluating Teverelix® in women with moderate-to-severe symptomatic endometriosis, with genomic stratification built into the core protocol rather than appended as exploratory analysis.

The study will enroll approximately 84 participants across multiple UAE investigational sites and evaluate three Teverelix treatment regimens, subcutaneous and intramuscular, with the primary objective of identifying a dose and route capable of achieving controlled estradiol suppression within the Barbieri Window while limiting hypoestrogenic adverse effects including vasomotor symptoms and bone loss. Bone turnover biomarkers, immunogenicity assessments, pharmacokinetic and pharmacodynamic measurements, and patient-reported outcomes are all pre-specified endpoints, placing significant demands on bioanalytical method validation and CMC documentation upstream of first patient in.

The distinguishing structural element is integration with the Emirati Genome Program (EGP), one of the largest national genomics initiatives globally. Participants enrolled in the EGP will contribute genomic data covering estrogen-signaling and gonadotropin pathways, allowing investigators to correlate genetic variation with hormonal response, symptom trajectory, and safety outcomes. For regulatory and clinical operations teams, this architecture means the IND package must account for genomic data handling, biomarker co-primary endpoints, and multi-modal dataset integrity, requirements that extend well beyond a conventional Phase 2a filing.

Teverelix is a long-acting GnRH antagonist. Medicus positions PRECISION-E2 as among the first prospective studies to evaluate a compound in this class within a precision medicine framework for endometriosis, a condition where treatment response variability remains poorly characterised at the genetic level. The combined dataset, genomic, pharmacodynamic, pharmacokinetic, and patient-reported, is intended to inform both the Teverelix development programme and broader understanding of estrogen-driven disease mechanisms.

Regulatory affairs leads preparing analogous genomics-integrated protocols will find the PRECISION-E2 design a reference point for how biomarker-stratified endpoints interact with ICH E16 and regional IND requirements outside established FDA or EMA frameworks.

Enrollment timelines and first-patient-in dates have not yet been disclosed; the measurable checkpoint to track is DOH IND approval and subsequent site activation across the UAE investigational network.

Source: Medicus Pharma Ltd. via GlobeNewswire, 11 June 2026.