Azitra, Inc. Shares Positive ATR-04 Preclinical Data at Dermatology Conference

Azitra, Inc., a clinical-stage biopharmaceutical company specializing in precision dermatology, has revealed promising preclinical data from its research platform and product pipeline. These findings were presented at the Society of Investigative Dermatology (SID) 2024 Annual Meeting, which took place on May 17, 2024, in Dallas, Texas. The presentations, titled “Staphylococcus epidermidis for the topical treatment of epidermal growth factor receptor (EGFR) inhibitor-induced dermal toxicity” and “Cutaneous delivery of LEKTI via an engineered strain of Staphylococcus epidermidis for the treatment of Netherton syndrome,” highlighted the potential of Azitra’s lead candidate, ATR-04.

ATR-04 is a live biotherapeutic product developed from a strain of Staphylococcus epidermidis. This strain was sourced from a healthy individual and modified to enhance safety by eliminating an antibiotic resistance gene and engineering auxotrophy to restrict its growth. The primary focus for ATR-04 is on addressing skin toxicity induced by EGFR inhibitors (EGFRi), a common issue affecting around 150,000 patients in the United States. EGFRi-induced skin toxicity arises from the suppression of skin immunity, resulting in inflammation and elevated levels of IL-36γ and Staphylococcus aureus.

The preclinical data presented demonstrated significant efficacy of ATR-04 in various models. In vitro skin models treated with ATR-04 showed a 96% reduction in methicillin-resistant Staphylococcus aureus (MRSA) compared to untreated skin. Furthermore, ex vivo pig skin treated with ATR-04 exhibited approximately a 99% decrease in MRSA levels. In human skin models subjected to erlotinib, an EGFR inhibitor, ATR-04 treatment led to a 75% reduction in IL-36γ levels, bringing them closer to those observed in untreated skin models. Additionally, ATR-04 treatment increased the presence of human beta defensin by 18-fold compared to the vehicle in human skin models. These findings suggest that ATR-04 effectively targets multiple factors contributing to EGFRi-induced skin toxicity.

Travis Whitfill, Azitra’s co-founder and COO, expressed enthusiasm about the first publication of preclinical data for ATR-04 in the context of EGFR inhibitor-associated dermal toxicity. He highlighted the robust preclinical activity demonstrated by ATR-04, which supports the company's plans to file an Investigational New Drug (IND) application with the FDA for a Phase 1b clinical trial in patients experiencing EGFR inhibitor-induced dermal toxicity. Whitfill also mentioned that the company expects to expand its clinical-stage pipeline within the year with ATR-04.

Azitra, Inc., focuses on developing therapies for precision dermatology by leveraging engineered proteins and topical live biotherapeutic products. Their proprietary platform includes a microbial library of approximately 1,500 unique bacterial strains, which are screened for therapeutic potential using artificial intelligence and machine learning. The company's initial emphasis is on developing genetically engineered strains of Staphylococcus epidermidis, identified as an optimal candidate for dermatologic therapies.

The recent preclinical findings underscore the potential of ATR-04 in treating EGFRi-induced skin toxicity, offering hope for improved management of this condition in patients undergoing EGFR inhibitor therapy. Azitra continues to push forward with its innovative approach to precision dermatology, aiming to bring effective and targeted treatments to the market.

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