Medicus secures UAE clearance for precision endometriosis trial
Medicus Pharma received regulatory clearance from the United Arab Emirates Department of Health - Abu Dhabi to begin PRECISION-E2, a prospective, randomized, placebo-controlled Phase 2a study of Teverelix in about 84 women with moderate-to-severe symptomatic endometriosis. The trial will randomize participants into four groups testing 60 mg subcutaneous, 90 mg subcutaneous, 90 mg intramuscular Teverelix, or subcutaneous placebo, and will measure the proportion maintaining serum estradiol 20–50 pg/mL for at least 14 consecutive days as its primary pharmacodynamic endpoint. Secondary measures include safety, pain, quality of life, immunogenicity, pharmacokinetics and bone biomarkers, and the company plans to integrate genomic data to seek response signatures.
UAE cleared Medicus' Phase 2a Teverelix trial in endometriosis.
Context
Medicus won UAE regulatory clearance to start its PRECISION-E2 Phase 2a study. The company also received recent FDA feedback and an IND "Study May Proceed" letter for other programs. The next steps are site enrollment in the UAE and later…
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