PHILADELPHIA, PA — Medicus Pharma Ltd. (Nasdaq: MDCX) reported topline results from a Phase 2 clinical trial evaluating a dissolvable microneedle patch designed to deliver chemotherapy directly into basal cell carcinoma tumors, the company announced Thursday.
The therapy, called a doxorubicin microneedle array, was studied as a potential non-surgical treatment for basal cell carcinoma, the most common form of skin cancer.
According to the company, the randomized, double-blind, placebo-controlled trial enrolled 90 patients with nodular basal cell carcinoma and evaluated two dose levels of the treatment compared with a placebo patch.
Participants were assigned to one of three groups: a placebo group, a low-dose group receiving 100 micrograms of the therapy and a high-dose group receiving 200 micrograms.
The primary endpoint measured clinical and histological tumor clearance at prespecified timepoints during the study.
The company said the highest-dose group achieved a clinical tumor clearance rate of 73% at Day 57 of the study.
Histological clearance, confirmed through tissue examination, was observed in 40% of patients in the same group, according to the results.
Chief Executive Officer Raza Bokhari said the findings support further development of the therapy.
“The observed increase in clearance rates at Day 57 in the higher-dose cohort reinforces the sustained biological activity of SkinJect and supports advancement into the next stage of development,” Bokhari said.
The company said it plans to seek an end-of-Phase 2 meeting with the U.S. Food and Drug Administration in the first half of 2026 to discuss next steps in the drug’s development.
Basal cell carcinoma occurs when abnormal cells develop in the skin’s basal layer and can cause lesions that often require surgical removal.
Medicus said the dissolvable microneedle patch is designed to deliver chemotherapy directly into tumors, potentially providing a localized treatment option without surgery.
The company said a full clinical study report, including additional safety data, is expected to be completed in the second quarter of 2026.
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