Medicus Pharma (NASDAQ:MDCX) announced that the United Arab Emirates Department of Health – Abu Dhabi (DOH) has granted Investigational New Drug (IND) authorization for its Phase 2a PRECISION-E2 clinical study evaluating Teverelix in women with moderate-to-severe symptomatic endometriosis.
The authorization follows the DOH's review of the company's chemistry, manufacturing and controls, non-clinical, clinical and safety documentation. The study has been approved to proceed, subject to site-specific institutional review board and ethics approvals.
The PRECISION-E2 trial is designed as a prospective, randomized, placebo-controlled Phase 2a study enrolling approximately 84 women with moderate-to-severe symptomatic endometriosis at multiple sites across the UAE.
Participants will be randomized into four treatment groups: Teverelix 60 mg administered subcutaneously, Teverelix 90 mg administered subcutaneously, Teverelix 90 mg administered intramuscularly, or placebo administered subcutaneously.
The study's primary pharmacodynamic endpoint is the proportion of participants who achieve and maintain serum estradiol levels within the established Barbieri therapeutic window of approximately 20-50 pg/mL for at least 14 consecutive days following treatment.
Secondary and exploratory endpoints include pharmacokinetic measurements, hormonal and bone turnover biomarkers, safety, immunogenicity, endometriosis-associated pain, quality-of-life assessments and exploratory genomic analyses.
Medicus said the study will also examine whether combining clinical, pharmacodynamic and genomic data can identify potential biomarkers associated with treatment response, estradiol suppression and tolerability. The company noted that any candidate biomarkers identified would require confirmation in subsequent clinical studies before being used to guide patient selection.
According to the company, PRECISION-E2 differs from conventional endometriosis studies by prospectively integrating genomic information with endocrine pharmacology, pharmacokinetics, biomarkers, safety assessments and patient-reported outcomes. Planned analyses include whole-genome information, subject to applicable approvals, alongside predefined genes and biological pathways linked to estrogen signaling, endometriosis biology, inflammation and pain perception.
Medicus said the trial is intended to support development of Teverelix as a precision medicine approach for women with moderate-to-severe endometriosis, a chronic estrogen-dependent inflammatory disease affecting an estimated one in 10 women of reproductive age worldwide.
The company said the study will evaluate whether Teverelix can achieve rapid, controlled and sustained estradiol suppression while generating data to inform dose selection, route of administration and future biomarker-guided development.
"Today's IND authorization represents far more than approval to initiate another clinical study. It validates a development strategy designed to combine precision endocrinology, pharmacology and population genomics within a prospective clinical trial,” Medicus CEO Dr. Raza Bokhari said in a statement.
“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 and may support future development across multiple women's health indications.”