Medicus Pharma Files FDA Protocol for 50-Patient Phase 2b SkinJect Trial
MDCX•Medicus Pharma submitted its SKNJCT-005 Phase 2b protocol to the FDA for registrational development of SkinJect in Gorlin Syndrome, targeting 6,000–12,000 U.S. patients with multiple basal cell carcinomas. The open-label study will evaluate visual clearance of lesions in up to 50 patients to support a future NDA.
1. Protocol Submission
In June 2026, Medicus Pharma submitted Protocol SKNJCT-005 to the FDA under its existing IND application to initiate a Phase 2b open-label registrational study of SkinJect in patients with Gorlin Syndrome. The submission marks a strategic advance into an orphan indication with no approved lesion-directed therapies.
2. Study Design and Endpoints
The multi-center trial will enroll up to 50 patients with multiple basal cell carcinomas, administering SkinJect 200 µg to two to four lesions per patient. The primary endpoint is complete clinical clearance of at least half of selected target lesions by Week 10, assessed via blinded central review of standardized photography.
3. Orphan and Priority Review Strategy
Medicus Pharma has applied for Orphan Drug Designation and plans to request a Rare Pediatric Disease Priority Review Voucher, aiming to secure fee exemptions and seven years of U.S. market exclusivity plus an expedited NDA review. These incentives could compress time to market and enhance program economics.
4. Prior Phase 2 Data
The Phase 2 SKNJCT-003 study in nodular basal cell carcinoma demonstrated 64% clinical clearance and 55% histological clearance at Day 57 with the 200 µg dose, alongside a favorable safety profile and no treatment-related serious adverse events. These results underpin the registrational study’s design parameters.
