Azitra Adds MD Anderson as Sixth Site for Phase 1/2 ATR-04 Trial
Azitra has added The University of Texas MD Anderson Cancer Center as its sixth clinical site for the Phase 1/2 ATR-04 trial, with Cohort 1 enrolling eight patients in a 3:1 randomized, double-blind, vehicle-controlled study. ATR-04, a topically applied live biotherapeutic with FDA Fast Track status, aims to treat EGFR inhibitor-associated rash affecting up to 80% of patients.
1. Expansion of Clinical Site
Azitra has expanded its ATR-04 clinical program by adding The University of Texas MD Anderson Cancer Center as the sixth trial site. MD Anderson treats thousands of cancer patients annually and its inclusion is expected to accelerate enrollment and key treatment milestones for the Phase 1/2 study.
2. Phase 1/2 Trial Design
The multicenter, randomized, double-blind, vehicle-controlled study (NCT06830863) randomizes patients 3:1 to receive ATR-04 or vehicle. The topical application covers the face, neck, chest, back and nailbeds, with Cohort 1 currently enrolling eight adult patients to assess safety, tolerability and early efficacy signals.
3. ATR-04 Therapeutic Profile
ATR-04 is a first-in-class live biotherapeutic containing an engineered Staphylococcus epidermidis strain designed to reduce IL-36γ and Staphylococcus aureus levels in EGFR inhibitor-associated rash. The candidate has received FDA Fast Track designation for the roughly 150,000 U.S. patients affected annually, highlighting its potential to enable uninterrupted cancer therapy.