On August 27, 2025 Azitra, Inc. ("Azitra") (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, reported 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 ("EGFRi")-associated rash (Press release, Azitra, AUG 27, 2025, View Source [SID1234655502]). Azitra has received Fast Track designation from the FDA for EGFRi associated rash, which impacts approximately 150,000 people in the U.S. annually.
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"Dosing the first patient is an important milestone in the advancement of ATR04-484 as a potential treatment for EGFRi associated rash and in the development of our broader ATR-04 technology program," said Francisco Salva, CEO of Azitra. "Given the importance of EGFRi treatments across multiple cancers, there is a critical medical need to reduce the impact of the unique dermatologic toxicities that often accompany EGFRi treatments, often leading to interruption or discontinuation of the treatment. This trial is a first step in ATR04-484 potentially addressing this patient need and market opportunity."
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 (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 (NCT06830863) 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 (3:1 randomization) 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.
ATR04-484 is a live biotherapeutic product candidate including an isolated, naturally derived Staphylococcus epidermidis strain in development for EGFRI-associated skin rash. The candidate was selected based on its preclinical profile of reducing IL-36γ and S. aureus levels, both of which are elevated in patients with EGFRi-associated skin rash. The strain was then engineered to be safe by deleting an antibiotic resistance gene and engineering auxotrophy to control the growth of ATR04-484.