PHILADELPHIA, PA — Medicus Pharma Ltd. (Nasdaq: MDCX) reported topline results from a Phase 2 clinical trial evaluating its Doxorubicin Microneedle Array treatment for basal cell carcinoma of the skin.
The study assessed the safety and efficacy of the therapy, known as D-MNA, in patients with nodular basal cell carcinoma.
The randomized, double-blind, placebo-controlled study enrolled 90 patients across multiple sites.
Participants were assigned to receive either a placebo microneedle array, a low dose of 100 micrograms of D-MNA, or a high dose of 200 micrograms.
The primary endpoint measured the proportion of patients achieving both visible clinical clearance and histological clearance of the tumor at specified timepoints.
Results were evaluated at Day 29 for 47 patients and Day 57 for 43 patients.
The company reported that tumor clearance rates increased between the two timepoints.
The 200-microgram dose group showed the highest response at Day 57, with 73% clinical clearance and 40% histological clearance.
Executive Chairman and Chief Executive Officer Raza Bokhari said the findings support further development of the treatment.
“We are extremely encouraged by these topline results, which not only validate management’s scientific and investment thesis, but also provide what we consider to be decision-grade evidence of clinical activity,” Bokhari said.
Medicus said the full clinical study report, including safety analyses, is expected to be completed in the second quarter of 2026.
The company said it plans to seek feedback from the U.S. Food and Drug Administration during an end-of-Phase 2 meeting in the first half of 2026.
Medicus said its development strategy is to advance selected therapies through Phase 2 proof-of-concept studies before pursuing licensing or partnership agreements for later-stage development and commercialization.
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