Medicus Pharma’s SkinJect® Phase 2 Data Validated By KOL, Showing Strong Efficacy In Basal Cell Carcinoma

Medicus Pharma Ltd. announced independent clinical validation of its Phase 2 SkinJect® data by Dr Babar Rao, a leading dermatologist and principal investigator of the SKNJCT-003 study. His evaluation supports the company’s position that the dataset is clinically meaningful and robust enough to guide future development and regulatory discussions.

The SKNJCT-003 trial is a randomised, double-blind Phase 2 study assessing SkinJect®, a microneedle-based platform delivering doxorubicin, in patients with nodular basal cell carcinoma (BCC). The study design enabled clear differentiation between the therapeutic effects of the drug and the device itself, while also measuring both visible tumor clearance and histological outcomes.

“Approximately three out of four treated lesions may achieve visual tumor clearance, potentially allowing many patients to avoid immediate surgical intervention.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 noted.

Results showed that the 200 µg dose cohort achieved the highest efficacy at Day 57, with an overall response rate of approximately 80%, clinical clearance of 73%, and histological clearance of 40%. The data also indicated sustained biological activity over time, leading Medicus to select this dose as the lead candidate for further development.

Dr. Rao, speaking in his capacity as principal investigator during the Company’s business update call, stated: “In my view as principal investigator, the dataset is clinically meaningful, supports continued development, and justifies regulatory engagement and further trials.”

Dr. Rao emphasised the clinical relevance of visual clearance, noting that patients achieving such outcomes may avoid invasive procedures like Mohs surgery. This positions SkinJect® as a promising non-surgical alternative, particularly for patients with limited access to surgery, those preferring less invasive treatments, or individuals with high lesion burdens, such as those with Gorlin Syndrome.