Medicus Pharma 200µg D-MNA Clears 64% of Skin Cancer Lesions at Day 57
MDCX•Medicus Pharma’s expanded Phase 2 analysis showed a positive dose-response for Doxorubicin Microneedle Array in nodular basal cell carcinoma, with 200µg achieving 64% clinical and 55% histologic clearance at Day 57 versus 29% in controls. Safety data showed no serious adverse events or systemic toxicity.
1. Expanded Dataset Analysis
Medicus Pharma conducted a pre-specified expanded dataset analysis of 69 patients from its Phase 2 SKNJCT-003 trial who met refined inclusion criteria, confirming trends from earlier topline results and prior Phase 1 findings.
2. Efficacy Outcomes by Dose
At Day 57, the 200µg D-MNA cohort recorded 64% clinical clearance and 55% histologic clearance, compared with 44% and 33% in the 100µg group and 29% for both measures in the device-only arm, indicating a clear dose-dependent effect.
3. Safety and Tolerability
Treatment was well tolerated with no drug-related serious adverse events or systemic doxorubicin toxicity reported; observed side effects were primarily mild, localized reactions at the application site.
4. Regulatory Pathway Implications
The robust dose-response findings and reproducibility across studies may inform endpoint selection and support future discussions with the US FDA as Medicus advances its end-of-Phase 2 regulatory strategy.
