Medicus Pharma Ltd. (NASDAQ: MDCX) announced that the United Arab Emirates Department of Health – Abu Dhabi has granted investigational new drug authorization for the company's PRECISION-E2 Phase 2a clinical study evaluating Teverelix® in women with moderate-to-severe symptomatic endometriosis.

The authorization follows the department's review of the company's chemistry, manufacturing and controls documentation, along with non-clinical, clinical and safety data. The study may proceed subject to completion of site-specific Institutional Review Board and ethics approvals.

PRECISION-E2 is a prospective, randomized, placebo-controlled study designed to enroll approximately 84 women across multiple sites in the UAE. Participants will be divided equally among four treatment groups: Teverelix® 60 mg subcutaneously, Teverelix® 90 mg subcutaneously, Teverelix® 90 mg intramuscularly, and a placebo administered subcutaneously.

The study's primary endpoint is the proportion of participants achieving and maintaining serum estradiol levels within the Barbieri therapeutic window of approximately 20–50 pg/mL for at least 14 consecutive days. Secondary endpoints include pharmacokinetic parameters, hormonal biomarkers, bone turnover biomarkers, safety, and quality-of-life assessments.

The study is also designed to prospectively integrate genomic data, including analysis of predefined genes such as ESR1, ESR2, CYP19A1, GNRHR, FSHR and LHCGR, with pharmacodynamic and clinical outcomes. The company states that any candidate biomarker identified through the study would require confirmation in subsequent trials before being used to guide patient selection.

Teverelix® is a long-acting gonadotropin-releasing hormone antagonist being developed by Medicus through its subsidiary, Antev Ltd. It is also under development for advanced prostate cancer and benign prostatic hyperplasia-related urinary retention.

Endometriosis affects approximately one in ten women of reproductive age worldwide, according to the press release.