PHILADELPHIA, PA — Medicus Pharma Ltd. (NASDAQ: MDCX) has received authorization from the Abu Dhabi Department of Health to begin a Phase 2a clinical trial of its investigational therapy Teverelix for women with moderate-to-severe endometriosis, advancing the company’s effort to evaluate a genomics-guided approach to treatment for the chronic disease.
The company reported that the Department of Health granted Investigational New Drug authorization for the PRECISION-E2 study after completing its scientific and regulatory review of the program. The trial may begin once site-specific institutional review board and ethics approvals are obtained.
The randomized, placebo-controlled Phase 2a study is expected to enroll approximately 84 women across multiple sites in the United Arab Emirates.
Participants will be assigned equally to one of four treatment groups: Teverelix administered subcutaneously at 60 milligrams, Teverelix administered subcutaneously at 90 milligrams, Teverelix administered intramuscularly at 90 milligrams, or placebo.
The study’s primary endpoint is the proportion of participants who achieve and maintain serum estradiol levels within the established therapeutic range of approximately 20 to 50 pg/mL for at least 14 consecutive days after treatment.
Secondary and exploratory endpoints include pharmacokinetic measurements, hormonal and bone-turnover biomarkers, safety, immunogenicity, endometriosis-related pain, quality-of-life assessments and genomic analyses.
Medicus indicated the trial is designed to evaluate whether clinical, pharmacodynamic and genomic data can identify biomarkers associated with treatment response. Any biomarkers identified would require confirmation in future studies before being used to guide patient selection.
Dr. Raza Bokhari, the company’s executive chairman and chief executive officer, characterized the authorization as validation of a development strategy that combines endocrinology, pharmacology and genomics within a prospective clinical trial.
“We believe PRECISION-E2 has the potential not only to optimize the future development of Teverelix but also is an important step toward personalized therapy that could help redefine how women with endometriosis and other estrogen-driven diseases are stratified,” Bokhari stated.
Unlike traditional endometriosis studies focused primarily on safety and efficacy, the company indicated the trial will prospectively integrate whole-genome information, endocrine pharmacology, pharmacokinetics, biomarkers and patient-reported outcomes to better understand differences in treatment response.
The exploratory genomic analysis will examine predefined genes and biological pathways involved in estrogen receptor signaling, estrogen synthesis and metabolism, gonadotropin signaling, inflammatory pathways, pain perception and endometriosis biology.
Endometriosis affects an estimated one in 10 women of reproductive age worldwide. The disease is associated with chronic pelvic pain, painful menstruation, infertility and reduced quality of life, while many patients continue to experience inadequate symptom control or recurrence despite currently available therapies.
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