Medicus Pharma Ltd. (NASDAQ: MDCX) announced that its Phase 2 clinical trial (SKNJCT-003) for D-MNA, a treatment for basal cell carcinoma (BCC), has randomized over half of its targeted 60 patients. The company anticipates completing an interim data analysis by the end of Q1 2025 and will submit the findings to the FDA, requesting a Type C meeting in Q2 2025 to discuss product development and potentially fast-track the clinical program. The SKNJCT-003 trial is evaluating two doses of D-MNA against a placebo control in patients with BCC.
This progress is particularly important because it signals potential advancements in non-invasive BCC treatments. Current treatments for BCC, while generally effective, can involve surgery or other invasive procedures. A successful outcome for D-MNA, administered via a dissolvable microneedle patch, could offer a significantly improved patient experience, potentially increasing treatment adherence and early intervention. This could lead to better outcomes and a reduction in healthcare costs associated with surgical procedures and follow-up care.
The Phase 2 trial builds upon the positive results of the Phase 1 safety and tolerability study (SKNJCT-001), which demonstrated that D-MNA was well-tolerated with no serious adverse events. Furthermore, the Phase 1 study indicated potential efficacy, with six participants experiencing complete responses, defined as the disappearance of BCC histologically. The current Phase 2 trial will assess the efficacy of two D-MNA doses (100μg and 200μg), the higher of which was the maximum dose used in the Phase 1 study. The trial’s randomized, double-blind, placebo-controlled design will provide robust data on D-MNA’s efficacy. The upcoming interim analysis and subsequent FDA meeting are critical milestones.
Positive interim data and a constructive Type C meeting with the FDA could significantly accelerate D-MNA’s development timeline. This could lead to a quicker path towards a pivotal Phase 3 trial and potential market approval. Successful development of D-MNA could position Medicus Pharma as a leader in non-invasive skin cancer treatments, opening up a substantial market opportunity and potentially transforming the standard of care for BCC.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
