Medicus Pharma Ltd. (MDCX) announced that it submitted an Investigational New Drug (IND) application to the Department of Health, Abu Dhabi, for a Phase 2a PRECISION-E2 genomics-enabled trial to evaluate Teverelix in women with symptomatic endometriosis in the United Arab Emirates (UAE).
Company Profile
Medicus Pharma is a clinical-stage biotechnology company focused on advancing novel therapeutic and drug-delivery technologies. Its pipeline includes SkinJect, a microneedle-based therapy for basal cell carcinoma, and it has a strategic collaboration with the Gorlin Syndrome Alliance to provide access to patients with Gorlin Syndrome.
Endometriosis
Endometriosis is a chronic estrogen-dependent inflammatory disease associated with debilitating pelvic pain, dysmenorrhea, infertility, and significantly impaired quality of life. The disease affects approximately one in ten women who are of reproductive age worldwide.
Teverelix
Teverelix is also known as Teverelix trifluroacetate, a gonadotrophin-releasing hormone (GnRH) antagonist developed by its subsidiary Antev Ltd. It suppresses the effect of reproductive hormones without the initial hormonal flare.
PRECISION-E2 Study Design
PRECISION-E2 is a Phase 2a, randomized, placebo-controlled clinical study that will assess the pharmacodynamics, safety, tolerability, clinical activity, and genomic correlation of teverelix in women with moderate-to-severe symptomatic endometriosis. The trial will enroll approximately 84 participants in the UAE.
The company indicated that it would test three treatment regimens for teverelix, which include both subcutaneous and intramuscular administration. The goal is to identify the optimal dose and method of administration that will effectively achieve estradiol suppression while maintaining a favorable safety profile.
Medicus is also incorporating the Emirati Genome Program to examine the genomic and phenotypic factors that affect treatment response and disease biology. This analysis aims to create a thorough precision medicine strategy for the treatment of patients with endometriosis.
The company also noted that, upon successful completion of the PRECISION-E2 trial, the results will facilitate their upcoming Phase 2b development in endometriosis.
MDCX is currently trading at $0.33, down 0.18%.
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