Azitra Begins Dosing in Phase 1b Trial of ATR-12 for Netherton Syndrome

Azitra, Inc., a precision dermatology company listed on NYSE American under the ticker AZTR, has commenced dosing in its Phase 1b clinical trial for ATR-12, a novel treatment for Netherton syndrome. Netherton syndrome is a chronic genetic skin disorder that can be life-threatening, characterized by a deficiency in the LEKTI protein. ATR-12 is Azitra's leading candidate, a proprietary strain of *Staphylococcus epidermidis* engineered to produce therapeutic levels of the missing LEKTI protein subunit.

The clinical trial aims to enroll around 12 adult patients who will receive the treatment twice daily for 14 days. The primary goals of the study are to evaluate the safety and tolerability of ATR-12. Secondary and exploratory endpoints will focus on efficacy signals and biomarkers. Azitra plans to release interim safety data in early 2025 and expects complete trial results in the latter half of the same year.

Azitra’s CEO, Francisco Salva, expressed enthusiasm about this milestone, highlighting its significance for both the company and patients dealing with Netherton syndrome. According to Salva, the initiation of patient dosing in this trial is a crucial step forward in their mission to provide relief to those suffering from this debilitating condition.

Mary Spellman, MD, the acting Chief Medical Officer of Azitra, also emphasized the importance of this clinical trial. Spellman noted that patients with Netherton syndrome often experience a poor quality of life due to the severity of their condition. She expressed optimism that this first-in-human study will pave the way for subsequent trials, including those involving pediatric patients and longer treatment durations.

The Phase 1b trial is a multicenter, randomized, double-blind, vehicle-controlled study. Participants will be treated with 10^9 CFU/g of ATR-12 or a vehicle control on opposite sides of the body twice daily for the 14-day period. The primary objective is to assess the safety and tolerability of the topical application of ATR-12. Secondary objectives include evaluating efficacy signals, such as investigator and patient global assessments, and assessing the skin pharmacokinetics of the LEKTI subunit. Additional exploratory objectives will look at pharmacodynamic parameters, various biomarkers, anti-LEKTI responses, and cytokine responses.

ATR-12, also known as ATR12-351, is designed to address the lack of the LEKTI protein in patients with Netherton syndrome. This condition affects approximately one to nine individuals per 100,000 and can be fatal. ATR-12 has been engineered to deliver the missing LEKTI protein when applied topically. The current Phase 1b clinical trial will assess its safety, tolerability, and efficacy, with initial safety data expected in early 2025.

Azitra, Inc. is a clinical-stage biopharmaceutical company focusing on precision dermatology solutions. Utilizing engineered proteins and topical live biotherapeutic products, the company has developed a proprietary platform. This platform includes a microbial library of about 1,500 unique bacterial strains, screened for therapeutic potential using artificial intelligence and machine learning technologies. Azitra's primary focus is on genetically engineered strains of *Staphylococcus epidermidis*, which the company believes to be an ideal candidate for dermatologic therapies.