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Azitra gets clearance to proceed with Cohort 2 of Phase 1/2 trial for ATR-04 after safety review
AZTRAzitra, Inc.
Azitra announced the completion of Cohort 1 in its Phase 1/2 clinical trial for ATR-04, a live biotherapeutic candidate targeting EGFR inhibitor-associated skin rash. Following a safety review by the study’s committee based on data from six patients, the company received clearance to proceed to Cohort 2. The trial is designed to evaluate the safety and tolerability of topical ATR-04 compared to its vehicle in adult patients. Azitra plans to enroll approximately 24 patients in Cohort 2, who will receive a once-daily 4g application for 28 days. The study is conducted at six sites, including MD Anderson Cancer Center and Yale University. The FDA has granted Fast Track designation to ATR-04 for this indication. Azitra operates as a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology.