Medicus Pharma secured UK regulatory and ethical approvals to expand its Phase 2 basal cell carcinoma trial (SKNJCT‑003). The approvals, granted by the Medicines and Healthcare products Regulatory Agency, the Health Research Authority, and the Wales Research Ethics Committee, allow the company to add UK sites to its existing nine U.S. sites and accelerate patient enrollment.
The trial is a randomized, double‑blind, placebo‑controlled study of the Doxorubicin Microneedle Array (D‑MNA). It is enrolling up to 90 participants, with 75 % already randomized, and an interim analysis has shown over 60 % clinical clearance, indicating promising efficacy.
Expanding into the UK strengthens Medicus’s global footprint and supports its strategy to bring a needle‑free, non‑invasive treatment to a market that could exceed $2 billion, with some estimates reaching $7 billion. The UK approval also positions the company for future regulatory submissions in other regions and enhances its pipeline for commercialization.
Dr. Raza Bokhari, Executive Chairman & CEO, emphasized the significance of the UK approval, noting it “represents more than $2 billion in potential market opportunity” and that the company’s programs are now active across the United States, Europe, and the Middle East, which will help design a robust pivotal program.
Medicus’s D‑MNA platform offers a non‑invasive alternative to traditional surgical treatments for basal cell carcinoma, potentially improving patient experience and reducing healthcare costs. The UK milestone is a key step toward achieving regulatory approval and commercial launch in the United Kingdom and beyond.
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