Medicus Pharma (NASDAQ:MDCX) announced that an independent assessment of its Phase 2 SkinJect study supports the clinical relevance of the data and continued development of the experimental therapy for non-melanoma skin cancer.
The evaluation was provided by Dr Babar Rao, principal investigator of the SKNJCT-003 trial, who described the dataset as “clinically meaningful” and supportive of further trials and regulatory engagement.
The SKNJCT-003 study is a randomized, double-blind, three-arm Phase 2 trial assessing microneedle-mediated delivery of doxorubicin against a device-only control in patients with nodular basal cell carcinoma.
The design allows researchers to distinguish the incremental effect of the drug from the underlying microneedle delivery platform while measuring both visual and histological clearance.
According to Medicus, the 200 microgram dose cohort showed the strongest activity at Day 57, with an overall response rate of about 80%, clinical clearance of 73%, and histological clearance of 40%. The company said these results informed its decision to advance the 200 microgram dose as the lead regimen.
“The clear separation between active drug and device-only control demonstrates a clinically meaningful therapeutic effect on top of a biologically active platform,” Dr Rao highlighted.
He also highlighted potential real-world implications, stating that roughly three out of four treated lesions achieved visual clearance, which could allow some patients to delay or avoid immediate surgery.
The company said such an approach could be particularly relevant for patients seeking less invasive treatments, those with limited access to Mohs surgery, or individuals with multiple lesions.
Dr Rao is a dermatologist, dermatopathologist, and Mohs surgeon with experience in skin oncology and clinical research. He serves as Professor of Dermatology and Pathology and Director of Clinical Research at Rutgers Robert Wood Johnson Medical School, and also holds academic appointments at Weill Cornell Medical College and California Health Sciences University.
He has authored more than 200 peer-reviewed publications and has led multiple clinical trials evaluating treatments for skin cancer and other dermatologic conditions.