FDA grants Azitra’s topically applied ATR-04 ‘fast track’ for EGFRi rash

Azitra announced the U.S. Food and Drug Administration FDA has granted Fast Track Designation for topically applied ATR-04 to treat moderate to severe Epidermal Growth Factor Receptor inhibitor EGFRi associated dermal toxicity. Francisco Salva, Azitra’s CEO, stated, “We are thrilled to announce the FDA has granted Fast Track designation to ATR-04, demonstrating that the FDA recognizes the unmet need for treatment of EGFRi-associated skin rash. Many cancer patients receive EGFR inhibitors, which often have significant side effects, resulting in rashes that require off-label treatment with antibiotics, steroids or other medications, or discontinuation of EGFRi therapy. The skin toxicity creates a high burden for these cancer patients, with a profound impact on their quality of life. We look forward to potentially accelerating the development of ATR-04 to treat this condition.” …Azitra plans to initiate a multicenter, randomized, controlled Phase 1/2 clinical trial of ATR-04 in patients with dermal toxicity due to EGFR inhibitors by the end of 2024.