Azitra gets FDA clearance for IND to treat skin rash from EGFR inhibitors

Azitra announced the clearance of an investigational new drug IND application to U.S. Food and Drug Administration FDA for a first-in-human Phase 1/2 clinical study of ATR-04 for moderate to severe EGFRi associated dermal toxicity. Francisco Salva, Azitra’s CEO, stated, “We are delighted to announce a new IND clearance in an indication with high unmet need. Many cancer patients receive EGFR inhibitors, which are efficacious for certain cancers. However, these EGFR inhibitors often have significant side effects, resulting in rashes that require treatment with antibiotics, steroids or other medications. ..Earlier this year, Azitra announced the preclinical data around ATR-04 at the Society for Investigative Dermatology SID annual meeting and the Annual Meeting for the American Society of Cell and Gene Therapy, showing significant reductions in IL-36gamma and methicillin-resistant S. aureus or MRSA in preclinical models. Following the clearance of the IND, Azitra plans to initiate a multicenter, randomized, controlled Phase 1/2 clinical trial of ATR-04 in patients undergoing EGFR inhibitors with dermal toxicity by the end of 2024.