Medicus Phase 2 Data Shows 55% Histologic Clearance at Day 57 with 200µg Dose
Medicus's Phase 2 SKNJCT-003 expanded analysis in 69 patients shows 200µg D-MNA achieved 64% clinical clearance and 55% histologic complete response at Day 57. No drug-related serious adverse events were observed, reinforcing a favorable safety profile and supporting End-of-Phase 2 FDA discussions.
1. Phase 2 SKNJCT-003 Expanded Analysis
The SKNJCT-003 study enrolled 90 patients with nodular basal cell carcinoma randomized into device-only, 100µg and 200µg D-MNA arms, of which 69 met nodular inclusion criteria for efficacy analysis at Day 29 and Day 57.
2. Dose-Response Results
The 200µg D-MNA cohort achieved 46% clinical clearance at Day 29 rising to 64% at Day 57 with a 55% histologic complete response, compared with 42% and 25% clinical and histologic clearance in the 100µg arm and 29% clearance in both endpoints for the device-only arm.
3. Safety and Tolerability
D-MNA was well tolerated with no drug-related serious adverse events, no evidence of systemic doxorubicin toxicity, and predominantly mild, localized treatment-site reactions consistent with prior Phase 1 observations.
4. Regulatory Implications
These expanded analysis findings strengthen the regulatory foundation for End-of-Phase 2 FDA discussions and position the 200µg regimen for potential registration-intent development and NDA-enabling studies.