Azitra expands ATR-04 Phase 1/2 trial to include patients with KRAS, MEK inhibitor-related rashes
AZTR•Azitra expanded its ongoing Phase 1/2 trial of topical ATR-04 to include patients with KRAS or MEK inhibitor-associated rashes. The added populations total approximately 85,000 U.S. patients annually, and the second cohort is expected to enroll about 24 patients for once-daily treatment over 28 days.
1. Trial expansion
Azitra expanded its ongoing Phase 1/2 trial of topical ATR-04 to include patients with KRAS or MEK inhibitor-associated rash, including people with neurofibromatosis type 1 who have MEK inhibitor-associated rash. Shorter antibiotic and steroid washout periods aim to accelerate recruitment.
2. Enrollment and safety
The added treatment populations total approximately 85,000 U.S. patients annually, beyond approximately 220,000 receiving EGFR inhibitors. Previously reviewed first-cohort safety data supported the safety review committee’s recommendation to advance to the second cohort, which is expected to enroll approximately 24 patients receiving once-daily treatment for 28 days.
