- Medicus Pharma's (MDCX, Financial) Phase 2 trial for nodular Basal Cell Carcinoma (BCC) shows over 60% clinical clearance rate in interim analysis.
- The trial will expand from 60 to 90 patients, with current enrollment surpassing 45 participants.
- Geographic expansion includes additional U.S. and new European sites, with approvals pending in UAE.
Medicus Pharma (MDCX) has announced an expansion of its Phase 2 clinical study (SKNJCT-003) for the treatment of nodular Basal Cell Carcinoma (BCC). The Institutional Review Board has approved an increase in patient enrollment from 60 to 90 participants. The study, currently active in nine U.S. clinical sites, will extend to additional locations within the U.S. and two new clinical sites in Europe.
The trial has successfully randomized more than 45 participants, and interim analysis indicates a promising complete clinical clearance rate exceeding 60%. The study evaluates the efficacy of two dose levels of D-MNA (100µg and 200µg) against a placebo, with both doses demonstrating a good safety profile and no serious adverse events or dose-limiting toxicities reported.
Medicus Pharma plans to submit a Type C meeting request to the FDA by the end of Q2 2025. Additionally, the company is seeking global validation with pending approval in Abu Dhabi and potential collaboration in the Asia-Pacific region.
The interim findings, while promising, are preliminary and may not correspond with the final study results. The trial's expansion represents a strategic step towards creating a non-invasive treatment option for a common form of skin cancer, potentially offering significant advancements in the field with global impacts.
