other material
confidence high
sentiment positive
materiality 0.50
Azitra clears ATR-04 safety review, advances Phase 1/2 trial to Cohort 2 enrollment
Azitra, Inc.
- Safety review committee cleared ATR-04 after reviewing Cohort 1 data; seven patients received a single 4g topical application to face, chest and back, then 28 days of once-daily dosing.
- Cohort 2 will enroll approximately 24 patients receiving 4g once daily for 28 days at six clinical sites, including MD Anderson Cancer Center and Yale University.
- The multicenter, randomized, double-blind, vehicle-controlled Phase 1/2 study (NCT06830863) uses 3:1 randomization comparing ATR04-484 to vehicle.
- ATR04-484 holds FDA Fast Track designation for EGFRi-associated rash, which affects roughly 50-80% of EGFR inhibitor patients and ~150,000 people annually in the U.S.
- CEO Francisco Salva said ATR-04 could become the first live biotherapeutic specifically developed for cancer treatment-associated rash.