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Azitra is developing ATR04-484 for the treatment of EGFR inhibitor-associated rash with plans to dose first patient in Phase 1/2 trial in the first half of 2025
BRANFORD, Conn., April 25, 2025 /PRNewswire/ -- Azitra, Inc. (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today announced that an abstract detailing the Phase 1/2 clinical trial of ATR04-484 in EGFR inhibitor ("EGFRi")-associated rash has been accepted for presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting being held May 30-June 3, 2025 in Chicago.
"We look forward to presenting an update on the ATR-04 program at ASCO as we plan to dose the first patient in the first half of 2025," said Francisco Salva, CEO of Azitra. "ASCO is widely regarded as the most prestigious cancer research conference in the world, and we are eager to educate leaders in the oncology community on the potential of ATR04-484 to treat the unique dermatologic toxicities that often accompany EGFRi treatments, which can hamper treatment efforts and cause significant physical and psychological discomfort for patients."
ATR04-484 is a live biotherapeutic product candidate including an isolated, naturally derived Staphylococcus epidermidis strain that was engineered to be safe by deleting an antibiotic resistance gene and engineering auxotrophy to control the growth of ATR04-484. ATR04-484 is in development for EGFRi-associated skin rash, which is associated with the suppression of skin immunity by EGFR inhibitors and subsequent inflammation, often accompanied by elevated levels of IL-36γ and S. aureus. Azitra has received Fast Track designation from the FDA for EGFRi associated rash and has initiated a Phase 1/2 clinical study in patients with EGFRi rash with the first patient expected to be dosed in the first half of 2025.
EGFR inhibitors are a class of cancer drugs that target and block the activity of the EGFR protein, which plays a crucial role in cell growth and survival. They are primarily used to treat certain types of cancer, including non-small cell lung cancer (NSCLC) and colorectal cancer.
The full ASCO abstracts will be available on May 22, 2025, after 5 p.m. ET. Abstract titles are available at: https://www.asco.org/abstracts.
About Azitra, Inc.
Azitra, Inc. is a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology. The Company's lead program, ATR-12, uses an engineered strain of S. epidermidis designed to treat Netherton syndrome, a rare, chronic skin disease with no approved treatment options. Netherton syndrome may be fatal in infancy with those living beyond a year having profound lifelong challenges. The ATR-12 program includes a Phase 1b clinical trial in adult Netherton syndrome patients. ATR-04, Azitra's additional advanced program, utilizes another engineered strain of S. epidermidis for the treatment of EGFR inhibitor ("EGFRi") associated rash. Azitra has received Fast Track designation from the FDA for EGFRi associated rash, which impacts approximately 150,000 people in the U.S. Azitra has an open IND for its ATR-04 program in patients with EGFRi associated rash. The ATR-12 and ATR-04 programs were developed from Azitra's proprietary platform of engineered proteins and topical live biotherapeutic products that includes a microbial library comprised of approximately 1,500 bacterial strains. The platform is augmented by artificial intelligence and machine learning technology that analyzes, predicts, and helps screen the library of strains for drug like molecules. For more information, please visit https://azitrainc.com.