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

$AZTRPress releaseOct 1, 2026, 8:00 AM ETRead the release

Azitra completed Cohort 1 of its Phase 1/2 trial of ATR04-484 for EGFR inhibitor-associated skin rash, with the safety review committee clearing the study to proceed to Cohort 2. Cohort 1 enrolled seven patients; Cohort 2 is expected to enroll approximately 24 patients receiving once-daily 4g application for 28 days, at six sites including MD Anderson and Yale. ATR-04 holds FDA Fast Track designation for an indication affecting roughly 150,000 U.S.

Key figures

Drug Name
ATR-04 (ATR04-484)
Phase Of Trial
Phase 1/2
Clinical sites
6
Cohort1 patients
7
Egfri rash incidence
50-80%
Cohort2 expected enrollment
24
Us annual patient population
150000

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