Core Insights - Medicus Pharma Ltd. has announced positive topline results from its Phase 2 clinical study (SKNJCT-003) evaluating the safety and efficacy of Doxorubicin Microneedle Array (D-MNA) for treating basal cell carcinoma (BCC) of the skin, with plans to finalize the Clinical Study Report (CSR) by Q2 2026 to support an end of Phase 2 meeting with the FDA [1][2][7] Clinical Study Overview - The SKNJCT-003 study was a randomized, double-blind, placebo-controlled trial involving 90 patients with nodular type BCC, assessing two dose levels of D-MNA against a placebo [3] - The primary endpoint was defined as achieving both clinical and histological clearance at a specified post-treatment timepoint [3] Topline Results - At Day 29 post-treatment, the clinical clearance rates were 33% for placebo, 47% for the 100µg D-MNA group, and 40% for the 200µg D-MNA group; histological clearance rates were 20%, 24%, and 27% respectively [4] - At Day 57, the 200µg cohort showed the highest activity with 73% clinical clearance and 40% histological clearance [4][6] Management Commentary - The CEO of Medicus expressed encouragement regarding the topline results, viewing them as decision-grade evidence of clinical activity, particularly at the 200µg dose level [5] - The increase in clearance rates at Day 57 supports the sustained biological activity of the treatment and strengthens the company's position in potential partnerships [6][7] Regulatory and Strategic Focus - The final CSR, including full safety analyses, is expected to be completed by Q2 2026, with no anticipated material changes to the reported efficacy findings [7] - The company aims to advance select programs through Phase 2 proof-of-concept and pursue licensing or strategic partnerships for late-stage development and commercialization [9]
Medicus Pharma Reports Positive Phase 2 SKNJCT-003 Topline Data Observing 73% Clinical Clearance and 40% Histological Clearance (CR) at Day 57 in 200μg Cohort