Key Takeaways:
PHILADELPHIA – Medicus Pharma Ltd. (NASDAQ: MDCX) announced its high-dose treatment for the most common type of skin cancer produced a 55 percent histological complete response rate in a mid-stage trial, bolstering the company’s plans to seek regulatory approval.
“We are confident that this dataset moves us from proof-of-concept to a clear registrational path, and we believe Skinject has the potential to fundamentally change the current approach of treating patients with BCC,” Dr. Raza Bokhari, Chairman and CEO of Medicus, said in a statement.
The results are from a pre-specified expanded analysis of the Phase 2 SKNJCT-003 study, which evaluated the Doxorubicin Microneedle Array, or D-MNA, branded as SkinJect. The 200µg high-dose cohort showed a 55% histological clearance, meaning no cancer was detected in post-treatment tissue samples, and a 64% clinical clearance rate at day 57. This compared to 33% histological and 44% clinical clearance for the low-dose (100µg) group, and 29% for both measures in the device-only control arm.
The data provides a strong efficacy signal for the 200µg dose and supports the company’s plans for an End-of-Phase 2 meeting with the US Food and Drug Administration. A positive outcome from that meeting would clarify the path for a final, pivotal study required for approval. The stock’s reaction to the news was not immediately available.
The randomized, double-blind study initially enrolled 90 participants, but the expanded analysis focused on 69 patients who were confirmed by central pathology to have the intended nodular basal cell carcinoma subtype.
The results demonstrated a progressive and dose-dependent improvement, with the strongest separation between the high-dose and control groups emerging at the 57-day mark. While the device-only arm showed some early biological activity, its effect did not increase over time. In contrast, the 200µg D-MNA cohort’s efficacy improved from day 29 to day 57, which the company said reinforces a drug-driven therapeutic effect.
The treatment, D-MNA, was generally well tolerated with no drug-related serious adverse events or signs of systemic toxicity.
The findings were supported by Dr. Babar K. Rao, the study's principal investigator and a professor at Rutgers Robert Wood Johnson Medical School, who noted the data shows "clinically meaningful rapid onset efficacy" and "clear differentiation between drug and device effect."
The results suggest that the therapy could offer a non-surgical alternative for BCC, a market opportunity Medicus estimates at around $2 billion when combined with the rare disease Gorlin Syndrome. The company is pursuing an Expanded Access Program to provide SkinJect to Gorlin Syndrome patients with inoperable tumors.
The positive data de-risks the advancement of the 200µg regimen. Medicus will use the findings to finalize the design of subsequent studies as it prepares for its EOP2 meeting with the FDA, which it expects to secure in the first half of 2026.
This article is for informational purposes only and does not constitute investment advice.
