Azitra Receives Study May Proceed Letter From The FDA For IND To Treat Skin Rash From EGFR Inhibitors

Author: Benzinga Newsdesk | August 22, 2024 09:01am

• New investigational new drug (IND) application cleared to proceed by the US FDA for a Phase 1/2 clinical study of ATR-04 for moderate to severe EGFR inhibitor ("EGFRi") associated dermal toxicity.
• There are an estimated 150,000 patients with EGFRi-associated skin rash in the US, representing a >$1 billion global market size.
• Preclinical data show ATR-04 reduces IL-36γ and Staphylococcus aureus, key drivers of EGFRi-associated skin rash.

Azitra, Inc. (NYSE:AZTR), a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today 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.

Posted In: AZTR