Medicus Pharma’s 200µg SkinJect Dose Yields 73% Clearance and Guides Next Steps
Medicus Pharma clarified its Phase 2 SkinJect dataset shows device-only microneedle arms served as mechanistic controls, and development will focus on the 100µg and 200µg doxorubicin-microneedle treatment arms. At Day 57 the 200µg cohort achieved 73% clinical clearance and 40% histological response, establishing it as the lead dose for registration.
1. Clarification on Control Arm
Medicus clarified that the P-MNA/C-MNA device-only arms contained no active drug and were included solely for mechanistic insights; these arms will not inform the clinical or regulatory path forward.
2. Active Treatment Arm Outcomes
In the 100µg cohort, 17 patients achieved 47% clinical clearance and 24% histological response at Day 29, improving to 42% and 33% by Day 57. The 200µg cohort of 15 patients recorded 40% clinical clearance and 27% histological response at Day 29, rising to 73% and 40% at Day 57.
3. Leading 200µg Dose for Registration
The sustained and highest response rates in the 200µg cohort have positioned it as the primary dose for the planned registrational study, guiding future trial design and dosing strategy.
4. Regulatory Path and Next Steps
Medicus plans to focus its upcoming End-of-Phase 2 meeting on the active treatment cohorts, refine study endpoints and biopsy timing, and advance partnering discussions to support regulatory approval.