Azitra Expands Patient Eligibility for ATR-04 Phase 1/2 Clinical Trial

Azitra, Inc. announced amendments to its ongoing Phase 1/2 clinical trial for its drug candidate, ATR-04, significantly expanding patient eligibility. The trial, which previously focused on skin rashes from EGFR inhibitors, will now include patients experiencing rashes from KRAS and MEK inhibitor cancer therapies. This change is expected to broaden the potential treatment applications for ATR-04 and accelerate patient enrollment.

Key Details

• Expanded Indications: The trial now includes patients with skin rashes associated with KRAS and MEK inhibitors, including those with neurofibromatosis type 1 (NF1). This adds to the initial focus on EGFR inhibitor-associated rashes.
• Market Opportunity: This expansion targets an additional ~85,000 U.S. patients annually treated with KRAS or MEK inhibitors, on top of the ~220,000 patients treated with EGFR inhibitors.
• Trial Status: The study has progressed to Cohort 2, which is expected to enroll approximately 24 patients who will receive once-daily treatment for 28 days. Protocol amendments also shorten washout periods to facilitate recruitment.