Core Insights - Azitra, Inc. has initiated the dosing of the first patient in its Phase 1/2 clinical trial for ATR04-484, targeting EGFR inhibitor-associated rash, which affects approximately 150,000 individuals annually in the U.S. [1][5] - The company has received Fast Track designation from the FDA for this treatment, highlighting the critical medical need to address dermatologic toxicities associated with EGFR inhibitor therapies [2][5] Company Overview - Azitra, Inc. is a clinical stage biopharmaceutical company focused on precision dermatology, with its lead program ATR-12 aimed at treating Netherton syndrome, a rare skin disease [5] - The ATR-04 program, which includes ATR04-484, is designed to mitigate skin toxicity from EGFR inhibitors, with a Phase 1/2 clinical trial currently underway [5] Clinical Trial Details - The Phase 1/2 clinical study is a multicenter, randomized, double-blind, vehicle-controlled trial aimed at evaluating the safety and tolerability of ATR04-484 for treating EGFRi-associated dermal toxicity [3] - The study will assess key objectives including safety, tolerability, and efficacy signals such as disease severity, pruritus, and pain [3] Product Candidate Information - ATR04-484 is a live biotherapeutic product candidate derived from a naturally occurring Staphylococcus epidermidis strain, engineered for safety and efficacy in reducing IL-36γ and S. aureus levels [4] - The product candidate was selected based on its preclinical profile, which indicates potential benefits for patients suffering from EGFRi-associated skin rash [4]