Azitra, Inc. announced on October 1, 2026, that its Phase 1/2 clinical trial evaluating ATR04-484 has advanced to Cohort 2 following clearance from the study's Safety Review Committee. The multicenter, randomized, double-blind, vehicle-controlled study (NCT06830863) is designed to assess the safety and tolerability of the topical live biotherapeutic for treating EGFR inhibitor (EGFRi)-associated skin rash.
The trial is currently being conducted at six clinical sites, including MD Anderson Cancer Center and Yale University. Cohort 1 involved seven patients who received a single 4g application of ATR04-484 to the face, chest, and back, followed by a 7-day observation period and once-daily application for 28 days. The safety review committee based its clearance on available safety data from six patients in this cohort.
Cohort 2 is expected to enroll approximately 24 patients who will receive a 4g application once daily for 28 days. ATR04-484 is a live biotherapeutic product candidate derived from an isolated, naturally derived Staphylococcus epidermidis strain. The candidate was engineered to delete an antibiotic resistance gene and induce auxotrophy to control its growth. Preclinical data indicates that ATR04-484 can reduce levels of IL-36γ and inhibit the growth of S. aureus.
EGFR inhibitors are used to treat cancers such as non-small cell lung cancer and colorectal cancer, but they frequently cause a painful papulopustular skin rash affecting approximately 50-80% of patients. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ATR04-484 for this indication, recognizing the high unmet medical need for the approximately 150,000 patients affected annually in the United States.
