USFDAJul 27, 2026, 08:20 AM
Medicus Pharma Receives FDA 'Study May Proceed' for SkinJect® Phase 2b
AI Summary
Medicus Pharma Ltd. announced that the U.S. Food and Drug Administration (FDA) has issued a "Study May Proceed" letter for its Investigational New Drug (IND) application for SKNJCT-005. This authorization allows the company to initiate a registrational Phase 2b clinical study evaluating SkinJect® (D-MNA) 200 mcg in patients with Gorlin Syndrome presenting with multiple basal cell carcinomas. The FDA's recommendations are expected to strengthen the study's scientific rigor and support long-term evaluation of treatment durability, positioning SkinJect® for a robust data package toward a potential NDA submission.
Key Highlights
- FDA issued a "Study May Proceed" letter for IND application SKNJCT-005.
- Authorizes initiation of NDA-enabling registrational Phase 2b clinical study for SkinJect®.
- Study evaluates SkinJect® (D-MNA) 200 mcg in Gorlin Syndrome patients with multiple basal cell carcinomas.
- FDA recommendations include baseline biopsy, revised primary efficacy endpoint, and extended follow-up to at least two years.
- Previous SKNJCT-003 study showed 64% clinical clearance and 55% histological clearance.
- Gorlin Syndrome affects an estimated 6,000 to 12,000 individuals in the U.S.
- SkinJect® aims to be the first FDA-approved lesion-directed therapy for Gorlin Syndrome.
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