Azitra, Inc. Announces Addition of MD Anderson Cancer Center as Clinical Site for Phase 1/2 Trial of ATR-04 Targeting EGFRi-Associated Skin Rash

Core Insights - Azitra, Inc. has announced the addition of MD Anderson Cancer Center as a clinical site for its Phase 1/2 trial of ATR-04, a treatment for EGFR inhibitor-associated skin rash, which affects up to 80% of patients receiving EGFRi therapies [1][2] Company Overview - Azitra, Inc. is a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, with its lead program ATR-12 targeting Netherton syndrome and ATR-04 aimed at treating EGFRi-associated rash [1][2] - The company has received Fast Track designation from the FDA for ATR-04, recognizing the high unmet medical need for approximately 150,000 patients affected annually in the United States [1] Clinical Trial Details - The Phase 1/2 clinical trial for ATR-04 is a multicenter, randomized, double-blind, vehicle-controlled study designed to evaluate the safety and tolerability of the product [1] - The trial will assess early efficacy signals and is currently enrolling patients for Cohort 1, which aims to include a total of eight patients [1] Product Information - ATR-04 is a first-in-class, topically applied live biotherapeutic product candidate that includes an isolated, naturally derived Staphylococcus epidermidis strain, engineered for safety and efficacy [1] - Preclinical data indicate that ATR-04 can reduce levels of IL-36 and inhibit the growth of Staphylococcus aureus, both of which are elevated in patients with EGFRi-associated skin rash [1]