Azitra, Inc. (NYSE American: AZTR), a leader in precision dermatology, has begun dosing the first patient in its Phase 1b trial of ATR-12 for Netherton syndrome. The trial will involve around 12 adult patients receiving twice-daily treatment for 14 days. The primary endpoints are safety and tolerability, while secondary and exploratory endpoints will evaluate efficacy and biomarkers. Azitra aims to release interim safety data in early 2025, with full results expected in the latter half of 2025.
Azitra, Inc. (NYSE American: AZTR) has launched its Phase 1b trial for ATR-12, its leading candidate designed to treat Netherton syndrome—a severe genetic skin condition. ATR-12 is a specialized strain of Staphylococcus epidermidis engineered to produce the LEKTI protein, which is deficient in Netherton syndrome patients.
“Dosing the first patient in this Phase 1b trial is a crucial milestone for both Azitra and those affected by Netherton syndrome,” said Francisco Salva, CEO of Azitra. “We are excited to begin and eager to see the results of this trial.”
Mary Spellman, MD, Azitra’s acting CMO, added, “Starting this trial marks an important step toward improving the quality of life for patients with Netherton syndrome. This first-in-human study will pave the way for future research, including trials involving pediatric patients and extended treatment periods.”
The Phase 1b trial (NCT06137157) is a multicenter, randomized, double-blind, vehicle-controlled study involving approximately 12 adult patients. Participants will receive ATR-12 or a vehicle control twice daily for 14 days. The primary goal is to assess the safety and tolerability of ATR-12, while secondary objectives include evaluating efficacy through global assessments and skin pharmacokinetics of the LEKTI subunit. Exploratory objectives will investigate pharmacodynamic parameters, biomarkers, and cytokine responses.
About ATR-12
ATR-12 (also known as ATR12-351) is an engineered S. epidermidis strain that produces the LEKTI protein, which is absent in Netherton syndrome patients. The Phase 1b trial aims to evaluate the safety and efficacy of this topical treatment. Initial safety data is expected in early 2025.
About Azitra, Inc.
Azitra, Inc. is a clinical-stage biopharmaceutical company specializing in precision dermatology. The company utilizes a proprietary platform, combining a library of 1,500 bacterial strains with AI and machine learning to develop innovative dermatologic therapies. Azitra focuses on genetically engineered strains of S. epidermidis to create novel treatments for skin diseases.
