Medicus Pharma (MDCX) announced results from a pre-specified expanded dataset analysis demonstrating positive dose response from its Phase 2 SKNJCT-003 study evaluating safety and efficacy of doxorubicin microneedle Array to treat nodular basal cell carcinoma of the skin. The expanded central pathology-verified efficacy analysis of 69 participants showed a progressive, dose-dependent improvement, with the 200microgram cohort achieving the highest clinical and histological clearance rates by day 57 vs. device-only control. The company said the dataset, which also confirmed a favorable safety and tolerability profile without drug-related serious adverse events or systemic doxorubicin toxicity, supports a registrational path and planned end-of-Phase 2 discussions with the FDA. “We are encouraged by these additional findings in the expanded analysis, which we believe meaningfully strengthens the clinical and regulatory foundation of the SKNJCT-003 Program,” said Raza Bokhari, chairman and CEO of Medicus.
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