Azitra Reports Promising Safety Data from Phase 1b Trial in Netherton Syndrome

Core Insights - Azitra, Inc. announced positive safety data from the Phase 1b clinical trial of its live biotherapeutic candidate ATR12-351, aimed at treating Netherton syndrome, a rare skin condition with no known cure [1][5]. Company Overview - Azitra, Inc. is a clinical stage biopharmaceutical company focused on innovative therapies for precision dermatology, with its lead program ATR-12 targeting Netherton syndrome [9]. - The company is also developing ATR-04, which addresses EGFR inhibitor-associated rash, and has received Fast Track designation from the FDA for this program [9]. Clinical Trial Details - The Phase 1b trial of ATR12-351 is designed to evaluate the safety and tolerability of the treatment, which involves applying an engineered strain of S. epidermidis to replace deficient LEKTI protein in patients with genetically confirmed Netherton syndrome [3][6]. - The trial is currently halfway enrolled, with six patients having received the treatment, and no severe adverse events reported thus far [4][8]. Disease Background - Netherton syndrome is a rare, autosomal recessive disease affecting approximately one in every 200,000 persons, characterized by severe skin inflammation and dehydration [2][7]. - The disease is caused by mutations in the SPINK5 gene, leading to a deficiency in the LEKTI protein, which is crucial for skin health [7]. Future Plans - Azitra plans to present findings from the Phase 1b trial of ATR12-351 and the Phase 1/2 trial of ATR04 at the BIO International Convention in Boston on June 17, 2025 [5].