Medicus Pharma Ltd. (NASDAQ:MDCX) on Friday secured regulatory clearance from the United Arab Emirates Department of Health – Abu Dhabi for its PRECISION-E2 Phase 2a clinical study.

The trial evaluates Teverelix in women with moderate-to-severe symptomatic endometriosis, an estrogen-dependent disease affecting roughly 10% of reproductive-age women globally.

The trial marks a significant milestone in advancing a prospective genomics-guided precision medicine program designed to identify patients most likely to respond to a long-acting GnRH antagonist.

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PRECISION-E2 Trial Design And Dosages

The prospective, randomized, placebo-controlled Phase 2a study will evaluate Teverelix across multiple investigational sites in the UAE, enrolling approximately 84 women.

Participants will be assigned equally across four groups: 60 mg subcutaneous Teverelix, 90 mg subcutaneous Teverelix, 90 mg intramuscular Teverelix, or a subcutaneous placebo.

Primary Endpoints And Future Objectives

The study’s primary pharmacodynamic endpoint measures the proportion of participants maintaining serum estradiol within the therapeutic Barbieri window of 20 to 50 pg/mL for at least 14 consecutive days.

Secondary endpoints assess safety, pain reduction, quality of life, immunogenicity, pharmacokinetic parameters, and bone turnover biomarkers.

Medicus intends to integrate clinical, pharmacodynamic, and genomic data to identify potential treatment-response signatures.

Any identified candidate signatures will require confirmation in subsequent trials prior to guiding patient selection.

Earlier in July, Medicus Pharma received written FDA feedback and central Institutional Review Board approval, with modifications, for its optimized Phase 2 clinical study of Teverelix in men following a first episode of acute urinary retention.

In July, the U.S. Food and Drug Administration (FDA) completed its safety review of Medicus Pharma’s Investigational New Drug application for SKNJCT-005 and issued a “Study May Proceed” letter.

The company can initiate an NDA-enabling registrational Phase 2b clinical study evaluating SkinJect (D-MNA) 200 mcg in patients with Gorlin Syndrome presenting with multiple basal cell carcinomas.

MDCX Stock Price Activity: Medicus Pharma shares were up 9.03% at $0.28 during premarket trading on Friday, according to Benzinga Pro data.

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