Medicus Pharma (TSX-V:MDCX, NASDAQ:MDCX) announced that its Phase 2 clinical study targeting basal cell carcinoma (BCC) is now being conducted at nine clinical sites across the United States, with more than 25% of the 60 patients expected to be enrolled in the trial.already randomized.
An interim data analysis is planned for the first quarter of 2025, and Medicus intends to submit these findings to the US Food and Drug Administration (FDA) to request a Type C meeting in Q2 2025, the company said on Monday.
The meeting aims to align on the clinical pathway and potentially transition the exploratory trial into a pivotal clinical trial to fast-track the program.
“We believe our novel therapy should receive a fast-track designation from the FDA and become a pivotal trial,” Medicus CEO Dr Raza Bokhari told Proactive.
“We’re seeking a Type C meeting with the FDA in late Q1 or early Q2 of 2025 to align further on our pathway. Interim data should be available before then, and we hope to share more good news soon.”
Additionally, the company announced an agreement with healthcare consulting firm Swanielle to explore expanding the Phase 2 study into the Asia-Pacific region.
The collaboration aims to identify potential pharmaceutical or biotech partners in Southeast Asia to facilitate this expansion.
The SKNJCT-003 trial is a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy of investigational product D-MNA at two dose levels (100μg and 200μg) compared to a placebo.
The maximum dose aligns with the dose used in Medicus’ Phase 1 study (SKNJCT-001), completed in March 2021, which demonstrated safety, tolerability, and promising efficacy.
“Our confidence comes from our 2021 Phase 1 safety and tolerability study, where six of 13 patients showed a complete clinical response,” Bokhari said. “If we can achieve this with six patients, we’re confident we can do it with 60.”