Medicus Pharma Phase 2 Microneedle Therapy Achieves 73% Clearance in BCC
Medicus Pharma’s Phase 2 trial of its doxorubicin microneedle array in 90 nodular basal cell carcinoma patients showed 73% clinical and 40% histological clearance at a 200-microgram dose by Day 57 versus 38% clinical clearance with placebo. The 100-microgram cohort achieved 42% clinical and 33% histological clearance at the same timepoint.
1. Trial Design and Patient Enrollment
Medicus Pharma conducted a randomized, double-blind, placebo-controlled Phase 2 study enrolling 90 patients with nodular basal cell carcinoma to assess its doxorubicin microneedle array (D-MNA) at two dose levels and a placebo control over a 57-day period.
2. Efficacy Outcomes by Dose Cohort
At Day 57, the 200-microgram cohort achieved 73% clinical clearance and 40% histological clearance confirmed by biopsy, while the 100-microgram cohort recorded 42% clinical and 33% histological clearance; the placebo arm showed 38% clearance on both measures.
3. Regulatory and Reporting Timeline
Medicus plans to request an end-of-Phase-2 meeting with the FDA in the first half of 2026 and expects to complete the full clinical study report, including safety analyses, by Q2 2026, with no anticipated material changes to efficacy findings.
4. Strategic Development and Partnership Goals
The company views these results as decision-grade evidence to advance SkinJect into late-stage development, aiming to leverage the dataset in ongoing and prospective licensing or strategic partnership discussions for commercialization.