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Azitra, Inc. Announces Addition of MD Anderson Cancer Center as Clinical Site for Phase 1/2 Trial of ATR-04 Targeting EGFRi-Associated Skin Rash

AZTR
  • Azitra, Inc. added The University of Texas MD Anderson Cancer Center as its sixth clinical site for the Phase 1/2 trial of ATR-04.
  • The trial evaluates ATR-04, a first-in-class topical live biotherapeutic, for treating EGFR inhibitor-associated rash.
  • The multicenter, randomized, double-blind study (NCT06830863) targets safety, tolerability, & early efficacy signals in adult patients.
  • Cohort 1 is currently enrolling eight patients with a 3:1 randomization ratio between ATR04-484 & its vehicle.
  • ATR-04 utilizes an engineered Staphylococcus epidermidis strain designed to reduce IL-36γ levels & inhibit S. aureus growth.
  • The FDA granted Fast Track designation to ATR-04, addressing an unmet need for approximately 150,000 U.S. patients affected annually.
  • Azitra also continues development of ATR-12 for Netherton syndrome, which holds an open IND for a Phase 1b trial.
  • The company's proprietary platform leverages a microbial library of ~1,500 strains enhanced by AI & machine learning.