Medicus advances Teverelix and SkinJect programs with key regulatory filings

Medicus Pharma CEO Dr Raza Bokhari joined Steve Darling from Proactive to discuss two significant regulatory milestones that advance the company’s pipeline in women’s health and rare disease oncology. The company has submitted an Investigational New Drug (IND) application to the Department of Health – Abu Dhabi for PRECISION-E2, a first-of-its-kind Phase 2a genomics-enabled clinical trial evaluating Teverelix® in women with symptomatic endometriosis. The randomized, placebo-controlled study is expected to enroll approximately 84 women across multiple sites in the UAE and will leverage participants from the Emirati Genome Program, one of the world’s largest national genomics initiatives. The trial is designed to combine clinical outcomes, hormonal biomarkers, pharmacokinetic and pharmacodynamic data, and genomic analysis to better understand treatment response variability. Researchers will evaluate three Teverelix treatment regimens with the goal of identifying the optimal dose and administration method while achieving controlled estradiol suppression within the therapeutic “Barbieri Window” and minimizing side effects such as hot flashes and bone loss. In a separate development, Medicus announced the submission of a Rare Pediatric Disease Designation (RPDD) request to the U.S. Food and Drug Administration for SkinJect®, its investigational doxorubicin-containing microneedle array patch, for the treatment of basal cell carcinoma in patients with Gorlin Syndrome, a rare inherited disorder associated with recurrent skin cancers. The RPDD application follows the company’s previously submitted Orphan Drug Designation request and its planned registrational study design, both of which remain under FDA review. Medicus said the development strategy for Gorlin Syndrome has been shaped through consultations with clinical experts and the Gorlin Syndrome Alliance patient advocacy organization. Management believes these regulatory filings represent important steps toward advancing precision medicine approaches in both endometriosis and rare skin cancer treatment, while potentially creating new therapeutic options for patients with significant unmet medical needs. #proactiveinvestors #nasdaq #mdcx #tsxv #mdcx #pharma #Teverelix #Endometriosis #PrecisionMedicine #Endometriosis #GorlinSyndrome #PrecisionMedicine #Biotech #ClinicalTrials #RareDisease #DrugDevelopment