Medicus Pharma Ltd. (NASDAQ: MDCX) announced top-line results from a Phase 2 clinical trial (SKNJCT-003) evaluating the safety and efficacy of doxorubicin microneedle arrays (D-MNA) for the treatment of basal cell skin cancer. The study demonstrates the potential for non-invasive treatment of skin cancer and is expected to positively impact an end-of-Phase 2 meeting with the FDA in the first half of 2026.
The clinical trial was a randomized, double-blind, placebo-controlled study involving 90 patients with nodular BCC. Data from Days 47 and 57 demonstrated the continued physiological activity of D-MNA, particularly at the high dose of 200 μg, with a 73% complete clinical response rate at Day 57. Dr. Raja Bokhari of Medicus welcomed the results, stating, "These results provide decisive evidence supporting self-care and investment strategies."
Medicus is currently preparing a final clinical study report (CSR), expected by the first half of 2026. While it is unclear whether these results will lead to FDA approval, the company is accelerating the preparation of data for future strategic partnerships. It is focused on evaluating the best path forward for development and commercialization and preparing the relevant study reports.
