Medicus Pharma wins FDA clearance to start SkinJect registrational Gorlin syndrome trial

Medicus Pharma wins FDA clearance to start SkinJect registrational Gorlin syndrome trial.

• Medicus received an FDA “study may proceed” letter, clearing its SKNJCT-005 Phase 2b registrational trial of SkinJect in Gorlin syndrome.
• The open-label, multicenter study targets up to 50 patients with multiple basal cell carcinomas; results are intended to support a potential NDA filing.
• The FDA review prompted protocol changes, including biopsy confirmation, a composite clinical-plus-histological clearance endpoint, and follow-up extended to at least two years.