Medicus Pharma (MDCX) said it submitted an Investigational New Drug application for the PRECISION-E2 Phase 2a study of Teverelix in women with symptomatic endometriosis, using the Emirati Genome Program to evaluate genomic predictors of treatment response, the company said Thursday.
The study, submitted to the Department of Health Abu Dhabi as an Investigational New Drug application, is a randomized, placebo-controlled trial in about 84 patients in the UAE assessing safety, efficacy, pharmacodynamics and genomic response, the company said.
Medicus said the trial will combine clinical, hormonal, pharmacokinetic and genomic data to assess treatment response variability while targeting controlled estradiol suppression and limiting side effects.
The study could support further Phase 2b development of Teverelix and expansion into other estrogen-driven indications, while generating an integrated clinical and genomic precision-medicine dataset, it added.