Medicus Completes Phase 2 Enrolment For D-MNA Microneedle Therapy In Basal Cell Carcinoma

Medicus Pharma Ltd. announced the successful completion of patient enrolment in its Phase 2 clinical trial, SKNJCT-003, evaluating the safety and efficacy of its Doxorubicin Microneedle Array (D-MNA) for the non-invasive treatment of nodular basal cell carcinoma (BCC) of the skin. A total of 90 patients have been enrolled across nine clinical sites in the United States.

The randomized, double-blind, placebo-controlled, multi-center study is assessing two dose levels of D-MNA compared with a placebo microneedle array. Participants were randomized equally to receive either placebo, a low dose of 100 μg D-MNA, or a high dose of 200 μg D-MNA. The high-dose regimen represents the maximum dose previously evaluated in the company’s completed Phase 1 trial.

“Successfully completing the U.S. enrollment of 90 patients for SKNJCT-003 brings us one more step closer to bringing to market a non-invasive, patient friendly, cost effective, localized immune therapy to treat basal cell carcinoma of the skin which we believe represents ~$2 billion in potential market opportunity” stated Dr. Raza Bokhari, Medicus’s Executive Chairman & CEO. “We are very hopeful that the clinical study report expected in H1 2026 will reaffirm the positively trending preliminary interim data analysis that the Company released earlier this year in Q1 2025 which showed more than 60% clinical clearance in 26 patients.”

Medicus expects to report topline results from the Phase 2 study in the first quarter of 2026 and plans to hold an end-of-Phase 2 meeting with the U.S. Food and Drug Administration in the first half of 2026 to discuss next development steps.

Earlier Phase 1 data (SKNJCT-001) demonstrated that D-MNA was well tolerated across all tested doses, with no dose-limiting toxicities or serious adverse events. The study also showed encouraging efficacy signals, including complete histological responses in six participants with nodular BCC, supporting continued clinical development of this novel, non-invasive therapeutic approach.