Other Events ·
Azitra expands ATR-04 Phase 1/2 trial eligibility to include KRAS and MEK inhibitor-associated rashes
AZTRAzitra, Inc.
Azitra, Inc. announced protocol amendments for its ongoing Phase 1/2 clinical trial of ATR-04-484 that significantly expand patient eligibility to include individuals with skin rash associated with KRAS and MEK inhibitors, as well as patients with neurofibromatosis type 1 (NF1) experiencing MEK inhibitor-associated rash. The amendments also shorten required washout periods for antibiotics and steroids to facilitate recruitment and accelerate enrollment. This expansion broadens the potential treatment opportunities beyond the initial focus on EGFR inhibitor-associated skin rash, adding approximately 85,000 annual patients in the U.S. undergoing KRAS or MEK inhibitor treatment and roughly 100,000 NF1 patients to the addressable pool. The multicenter study is evaluating the safety, tolerability, bioavailability, pharmacodynamics, and preliminary efficacy of topical ATR-04-484. Cohort 2 is expected to enroll approximately 24 patients receiving once-daily treatment for 28 days following a safety review committee recommendation to proceed from Cohort 1. Azitra, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology and novel products across therapeutics, cosmeceuticals, and biotechnology applications.