Core Insights - Azitra, Inc. announced positive preclinical progress for its ATR-01 program targeting ichthyosis vulgaris, a genetic disorder affecting approximately 1.3 million people in the U.S. [1][2] - The ATR-01 program utilizes an engineered strain of S. epidermidis, ATR01-616, which secretes functional filaggrin, showing promising results in preclinical models [2][3] - The company plans to present detailed data at the BIO-Europe conference in November 2025 and aims to submit an IND for ATR-01 in 2026 [1][3] Company Overview - Azitra, Inc. is a clinical stage biopharmaceutical company focused on precision dermatology, with its lead program ATR-12 targeting Netherton syndrome, a rare skin disease [3] - The company also has an advanced program, ATR-04, for treating EGFR inhibitor-associated rash, which has received Fast Track designation from the FDA [3] - Azitra's programs are developed from a proprietary platform of engineered proteins and topical live biotherapeutic products, supported by artificial intelligence and machine learning [3]

Core Insights - Azitra, Inc. is presenting a poster on its Phase 1/2 clinical trial of ATR04-484 for treating EGFR inhibitor-associated rash at ASCO 2025 [1][2] - ATR04-484 is a live biotherapeutic product derived from Staphylococcus epidermidis, engineered for safety and efficacy [2][4] - The FDA has granted Fast Track designation for ATR04-484, which addresses a significant dermatologic toxicity affecting approximately 150,000 patients in the U.S. [5] Company Overview - Azitra, Inc. focuses on innovative therapies for precision dermatology, with its lead program ATR-12 targeting Netherton syndrome, a rare skin disease [5] - The company utilizes a proprietary platform of engineered proteins and a microbial library of around 1,500 bacterial strains, enhanced by AI and machine learning [5] Clinical Trial Details - The Phase 1/2 trial is multicenter, randomized, double-blind, and vehicle-controlled, assessing the safety and tolerability of ATR04-484 [2][3] - The presentation at ASCO 2025 will be led by Mary Spellman, MD, Chief Medical Officer, and will focus on the treatment of EGFRi-induced dermal toxicity [4]

Company Overview - Azitra, Inc. is a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology [4] - The company's lead program, ATR-12, targets Netherton syndrome, a rare chronic skin disease, while ATR-04 is aimed at treating EGFR inhibitor-associated rash [4] - Azitra has received Fast Track designation from the FDA for EGFRi associated rash, which affects approximately 150,000 people in the U.S. [4] Product Development - Azitra is developing ATR04-484 for the treatment of EGFR inhibitor-associated rash, with plans to dose the first patient in a Phase 1/2 trial in the first half of 2025 [1][2] - ATR04-484 is a live biotherapeutic product candidate that includes an isolated, naturally derived Staphylococcus epidermidis strain, engineered for safety [2] - The product is designed to address the dermatologic toxicities associated with EGFR inhibitors, which can lead to significant discomfort for patients [2] Clinical Trials and Presentations - An abstract detailing the Phase 1/2 clinical trial of ATR04-484 has been accepted for presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting [1][2] - The full ASCO abstracts will be available on May 22, 2025 [3] Market Context - EGFR inhibitors are a class of cancer drugs used primarily to treat non-small cell lung cancer (NSCLC) and colorectal cancer [3] - The development of ATR04-484 is significant as it addresses a common side effect of EGFR inhibitors, which can hinder treatment efforts [2]