Azitra doses first patient in Phase 1/2 clinical trial of ATR04-484

Azitra (AZTR) announced the dosing of the first patient in its Phase 1/2 clinical trial of ATR04-484, a topically applied live biotherapeutic product candidate designed to treat EGFR inhibitor, or EGFRi,-associated rash. Azitra has received Fast Track designation from the FDA for EGFRi associated rash, which impacts approximately 150,000 people in the U.S. annually. Targeted cancer therapies, like EGFRis, have produced significant treatment advances for patients diagnosed with a variety of tumor types including non-small cell lung cancer, or NSCLC, and colorectal cancer, but they are also associated with unique dermatologic toxicities. These side effects can severely hamper treatment efforts, causing significant physical and psychological discomfort for patients. The papulopustular rash is often the earliest and most common dermatologic adverse event of EGFRi treatment and can occur in 50-80% of patients, often impacting quality of life severely enough to interrupt or stop cancer treatment. The multicenter, randomized, double-blind, vehicle-controlled Phase 1/2 clinical study is designed to evaluate the safety and tolerability of topical ATR04-484 for the treatment of EGFRi-associated dermal toxicity affecting the face of adult patients. ATR04-484 or its vehicle will be applied to the face as well as affected areas on the neck, chest, back, and areas around nailbeds. The key objectives of the study will be to assess the safety and tolerability of topical ATR04-484 and to evaluate efficacy signals including severity of disease, pruritus, and pain. The bioavailability of ATR04-484 and pharmacodynamic parameters will also be studied. This clinical study will establish the basis for continued clinical development of ATR04-484.