Azitra, Inc. is a pre-clinical biopharmaceutical company focused on developing precise treatments for various dermatological conditions. They innovate by utilizing engineered proteins and live biotherapeutic products to address skin diseases. The company's pipeline features several key therapeutic candidates: ATR-12: A genetically modified strain of S. epidermidis intended to treat Netherton syndrome, a specific skin disorder. ATR-04: Another modified S. epidermidis strain, designed to alleviate the papulopustular rash commonly experienced by cancer patients undergoing epidermal growth factor receptor inhibitor therapy. ATR-01: An engineered recombinant human filaggrin protein developed for the treatment of ichthyosis vulgaris, another dermatological ailment. Founded in 2014, Azitra, Inc. operates from its headquarters in Branford, Connecticut.
Azitra, Inc. Advances ATR-04 Phase 1/2 Clinical Trial to Cohort 2 Following Safety Review Committee Clearance
Azitra completed Cohort 1 of its Phase 1/2 trial of ATR04-484 for EGFR inhibitor-associated skin rash, with the safety review committee clearing the study to proceed to Cohort 2.
Cohort 1 enrolled seven patients; Cohort 2 is expected to enroll approximately 24 patients receiving once-daily 4g application for 28 days, at six sites including MD Anderson and Yale.
ATR-04 holds FDA Fast Track designation for an indication affecting roughly 150,000 U.S. patients annually; the safety clearance de-risks the program but efficacy data remain pending.