Azitra Advances ATR-04 Clinical Trial to Second Cohort After Safety Clearance

Azitra, Inc. announced that its Phase 1/2 clinical trial for ATR-04 has advanced to its second cohort. The decision follows a recommendation from the study’s safety review committee, which cleared the trial to proceed after reviewing safety data from the first patient cohort. ATR-04 is being developed as a potential treatment for skin rash associated with EGFR inhibitor (EGFRi) cancer therapies.

Key Details

• Trial Update: The multicenter, randomized, double-blind, vehicle-controlled Phase 1/2 study (NCT06830863) has completed Cohort 1, which involved 7 patients.
• Next Steps: The company will now begin enrollment and dosing for Cohort 2, which is expected to include approximately 24 patients who will receive a daily application for 28 days.
• Product Information: ATR-04 is a live biotherapeutic product candidate that has received Fast Track designation from the U.S. FDA for treating EGFRi-associated rash, which affects an estimated 150,000 patients annually in the U.S.