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Azitra, Inc. Advances ATR-04 Phase 1/2 Clinical Trial to Cohort 2 Following Safety Review Committee Clearance

AZTR
  • Azitra, Inc. announced the completion of Cohort 1 in its Phase 1/2 clinical trial for ATR04-484, a potential treatment for EGFR inhibitor-associated skin rash.
  • A safety review committee recommended proceeding to Cohort 2 after reviewing safety data from six patients in the first cohort.
  • Cohort 2 is expected to enroll approximately 24 patients who will receive a 4g daily application of ATR04-484 for 28 days.
  • The multicenter, randomized, double-blind study is conducted at six sites, including MD Anderson Cancer Center & Yale University.
  • ATR04-484 is a live biotherapeutic product engineered to reduce IL-36γ levels & inhibit Staphylococcus aureus growth.
  • The U.S. Food & Drug Administration has granted Fast Track designation to ATR04-484 for this indication.
  • EGFR inhibitors cause severe skin rashes in 50-80% of patients, often leading to treatment interruptions or discontinuations.
  • Approximately 150,000 patients in the U.S. are affected annually by EGFR inhibitor-associated rash.