Medicus Pharma (NASDAQ:MDCX) announced that it has completed enrollment of 90 patients in its Phase 2 clinical study evaluating a non-invasive treatment for basal cell carcinoma (BCC) of the skin.
The study, known as SKNJCT-003, is assessing the safety and efficacy of the company’s doxorubicin microneedle array (D-MNA) in patients with nodular BCC.
The trial is being conducted at nine clinical sites across the United States.
In the trial, patients are randomized in a 1:1:1 ratio to receive either a placebo microneedle array (P-MNA), a low-dose treatment of 100 micrograms of D-MNA, or a high-dose treatment of 200 micrograms of D-MNA.
The 200-microgram dose represents the highest dose evaluated in the company’s earlier Phase 1 safety and tolerability study, SKNJCT-001, which was completed in March 2021.
Medicus said it expects to report topline results from the Phase 2 trial before the end of the first quarter of 2026.
The company also plans to request an end-of-Phase 2 meeting with the US Food and Drug Administration in the first half of 2026 to discuss the study results and potential next steps.
“Successfully completing the US enrollment of 90 patients for SKNJCT-003 brings us one more step closer to bringing to market a non-invasive, patient-friendly, cost-effective, localized immune therapy to treat basal cell carcinoma of the skin, which we believe represents ~$2 billion in potential market opportunity,” Medicus Pharma CEO Dr Raza Bokhari said in a statement.
“We are very hopeful that the clinical study report expected in H1 2026 will reaffirm the positively trending preliminary interim data analysis that the company released earlier this year in Q1 2025, which showed more than 60% clinical clearance in 26 patients.”
Shares of Medicus were around 1.6% higher by midday Monday.