Medicus Pharma Expands Phase 2 Trial For Treatment Of Nodular Basal Cell Carcinoma (BCC), Followed By IRB Approval

Medicus Pharma Ltd. has announced that the company has received Institutional Review Board (IRB) approval to expand the number of participants in its ongoing Phase 2 clinical study (SKNJCT-003) from 60 to 90 patients. The trial, currently being conducted at nine clinical sites in the United States, will now broaden to additional locations in the  U.S. and two new sites in Europe, further advancing the development of the company's investigational product, D-MNA. 

The study is designed as a randomised, double-masked, placebo-controlled, multi-centre trial enrolling subjects with basal cell carcinoma (BCC) of the skin. Participants are being randomised in a 1:1:1 ratio into three groups: one receiving a placebo (P-MNA), one receiving a low dose (100μg) of D-MNA, and one receiving a high dose (200μg) of D-MNA. The company announced that over 45 participants have already been randomised into the study.

“Increasing the number of participants in the study and expanding the clinical trial sites in Europe is very timely. With our study design awaiting approval by the Department of Health in Abu Dhabi, and exploring collaboration in the Asia-Pacific region, we are promising progress in securing global validation of our novel, non-invasive treatment for BCC,” stated Dr. Raza Bokhari, Executive Chairman & CEO.

Medicus is on track to submit a formal package to the U.S. Food and Drug Administration (FDA) requesting a Type C meeting by the end of the second quarter 2025. An interim analysis released in March 2025 revealed promising results, showing over 60% of participants experienced complete clinical clearance. Both dose levels (100μg and 200μg) of D-MNA were well tolerated, with no dose-limiting toxicities or serious adverse events reported. There were also no systemic effects or clinically significant changes in safety parameters. These results are preliminary and may not reflect outcomes upon study completion.