Medicus Pharma Gains UK Approval to Expand Phase 2 Trial Of Doxorubicin Microneedle Therapy for Basal Cell Carcinoma

Medicus Pharma Ltd. announced that it has obtained full regulatory and ethical approvals in the United Kingdom to expand its ongoing Phase 2 clinical trial (SKNJCT-003) evaluating its novel Doxorubicin Microneedle Array (D-MNA) for the non-invasive treatment of basal cell carcinoma (BCC) of the skin. Previously conducted across nine clinical sites in the United States, the study can now broaden its reach by opening additional participating centers in the U.K.

“The United Kingdom regulatory and ethical approval is another major step forward in establishing a global footprint of our novel, non-invasive treatment for BCC of the skin, which we believe represents more than $2 billion in potential market opportunity,” stated Dr. Raza Bokhari, Medicus’s Executive Chairman & CEO. “With clinical development programs now active across United States, Europe, and the Middle East, we are enhancing global patient recruitment and clinical dataset which, among other things, would assist us in designing a robust pivotal program”.

The approvals were granted by the Medicines and Healthcare products Regulatory Agency (MHRA), the Health Research Authority (HRA), and the Wales Research Ethics Committee (WREC). The MHRA authorization followed an in-depth review of the Investigational Medicinal Product Dossier (IMPD) and clinical protocol. WREC provided a favorable ethical opinion, while HRA issued site-wide governance approval, confirming alignment with U.K. Good Clinical Practice (GCP) and NHS research standards.

The SKNJCT-003 trial is a randomized, double-blind, placebo-controlled, multi-center study designed to enroll up to 90 patients with BCC. Participants will be assigned to one of three arms: placebo microneedle array (P-MNA), low-dose D-MNA (100 μg), or high-dose D-MNA (200 μg). The 200 μg high dose reflects the maximum level evaluated in Medicus’ earlier Phase 1 safety and tolerability study (SKNJCT-001) completed in March 2021. This expansion marks a significant step forward in evaluating a potentially transformative, non-invasive treatment for one of the most common forms of skin cancer.