Medicus Pharma advances Phase 2 clinical study, eyes FDA fast-track approval
Published: 15:05 18 Feb 2025 EST
Medicus Pharma CEO Dr Raza Bokhari joined Steve Darling from Proactive to announce significant progress in the company’s Phase 2 clinical study, currently being conducted across nine clinical sites in the United States. The study has now randomized over 50% of its expected 60 patients.
The company remains on track to complete an interim data analysis by Q1 2025 and plans to submit its findings to the U.S. Food and Drug Administration (FDA) as part of a Type C meeting request in Q2 2025. The purpose of this meeting is to discuss the clinical development pathway and potentially secure FDA approval to fast-track the program.
The SKNJCT-003 clinical trial is a randomized, double-blind, placebo-controlled, multi-center study designed to assess the efficacy of two dose levels of D-MNA in treating basal cell carcinoma (BCC) of the skin. Patients are being randomized into three groups. The 200μg high-dose of D-MNA was previously tested in Medicus Pharma’s Phase 1 safety and tolerability study (SKNJCT-001), completed in March 2021.
With enrollment progressing and regulatory discussions on the horizon, Medicus Pharma is positioned to accelerate its clinical program, potentially bringing an innovative treatment for BCC closer to market approval.
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