Xinnate AB
🇸🇪Sweden
FDA Upgrades Xinnate's TCP-25 Trial for Epidermolysis Bullosa to Registrational Status
• Following a successful Type C meeting with the FDA, Xinnate's upcoming STEP trial for TCP-25 in Epidermolysis Bullosa patients has been upgraded to serve as a registrational trial.
• TCP-25, an immunomodulatory peptide with dual-action capabilities targeting both inflammation and bacterial infection, previously received Orphan Drug Designation from the FDA for EB treatment.
• The STEP trial, planned to begin in 2025, is designed as an international multicenter, randomized, double-blind, placebo-controlled study to assess TCP-25's efficacy and safety in dystrophic and junctional EB patients.
FDA Grants Orphan Drug Designation to Xinnate's TCP-25 for Epidermolysis Bullosa Treatment
• The US FDA has granted Orphan Drug Designation to Xinnate's TCP-25, an immunomodulatory peptide developed for treating the rare skin disease Epidermolysis Bullosa.
• TCP-25 demonstrates dual-action capabilities by targeting both inflammation and bacterial infection in wounds, potentially offering more effective healing for EB patients.
• The designation provides Xinnate with benefits including tax credits, FDA fee exemptions, and seven years of market exclusivity following approval, supporting the company's plans for Phase 2 trials in 2025.
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