Medicus Pharma’s SkinJect Phase 2 Hits 80% Response, 73% Clinical Clearance
Medicus Pharma’s Phase 2 SKNJCT-003 trial of microneedle-delivered doxorubicin in nodular basal cell carcinoma achieved an 80% overall response rate, including 73% clinical and 40% histological clearance at the 200 µg dose. Independent KOL validation deems the dataset decision-grade, supporting regulatory engagement and further development.
1. KOL Validation of SkinJect Phase 2 Data
Dr. Babar Rao, principal investigator of SKNJCT-003, provided independent clinical validation of the Phase 2 dataset, describing the results as clinically meaningful, decision-grade and supportive of continued development and regulatory engagement.
2. SKNJCT-003 Trial Design and Efficacy Results
The randomized, double-blind, three-arm trial compared microneedle delivery of doxorubicin against device-only control in nodular basal cell carcinoma. At the 200 µg dose cohort on Day 57, the study achieved an 80% overall response rate, including 73% clinical and 40% histological clearance.
3. Potential Clinical Impact and Development Path
Approximately 75% of lesions achieved visual clearance, potentially allowing patients to avoid immediate surgery and opt for less invasive monitoring. These findings support selection of the 200 µg regimen for further trials and regulatory discussions targeting patients lacking Mohs surgery access or with high lesion burdens.