Medicus Pharma Launches 84-Participant Phase 2a Endometriosis Genomics Trial
MDCX•Medicus Pharma filed an IND in Abu Dhabi to launch PRECISION-E2, a randomized Phase 2a trial testing Teverelix® in 84 UAE women with moderate-to-severe endometriosis. The study uses Emirati Genome Program data to link genomic variants to pharmacodynamics, safety and symptom response, aiming to optimize dosing regimens and biomarkers.
1. IND Submission and Trial Launch
Medicus Pharma submitted an IND application to Abu Dhabi’s Department of Health to initiate PRECISION-E2, marking the first genomics-enabled Phase 2a study of Teverelix® in women with moderate-to-severe endometriosis in the UAE. The trial will enroll approximately 84 participants across multiple sites.
2. Study Design and Genomic Integration
PRECISION-E2 is a randomized, placebo-controlled trial assessing three Teverelix regimens via subcutaneous and intramuscular administration. It integrates Emirati Genome Program data to explore how genetic variants in estrogen and gonadotropin pathways correlate with treatment response variability.
3. Teverelix Dosing and Safety Focus
The study aims to identify optimal dosing to achieve controlled estradiol suppression within the Barbieri Window while minimizing hypoestrogenic side effects such as vasomotor symptoms and bone loss. Pharmacodynamic, pharmacokinetic, safety, and patient-reported outcomes will be evaluated.
4. Future Development and Precision Medicine Implications
Successful completion could support a Phase 2b program in endometriosis and inform other estrogen-driven indications like uterine fibroids. The genomic insights may enable identification of biomarkers to personalize hormonal therapies for women’s health disorders.
