Azitra, Inc. Announces Positive Preclinical Data from ATR-04 Presented at the Society of Investigative Dermatology Annual Meeting

Azitra, Inc. (NYSE American: AZTR), a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today announced preclinical data from the Company’s platform and pipeline. The data are being presented on Friday, May 17, 2024, in two oral sessions entitled “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” at the Society of Investigative Dermatology (SID) 2024 Annual Meeting in Dallas, TX.

“We are pleased to announce the first publication of preclinical data around ATR-04 in EGFR inhibitor (EGFRi)-associated dermal toxicity,” said Travis Whitfill, Azitra’s co-founder and COO. “These data show robust preclinical activity of ATR-04 in models of EGFRi-induced dermal toxicities that support an upcoming Investigational New Drug (IND) application to the FDA for a Phase 1b in patients undergoing EGFR inhibitors with dermal toxicity. We anticipate the expansion of our clinical-stage pipeline this year with ATR-04.”

ATR-04 is a live biotherapeutic product candidate consisting of an S. epidermidis strain that was isolated from a healthy volunteer and engineered to be safer by deleting an antibiotic resistance gene and engineering auxotrophy to control the growth of ATR-04. ATR-04 is in development for EGFRi-associated skin toxicity, which is caused by the suppression of skin immunity by EGFRis and subsequent inflammation and often elevated levels of IL-36γ and S. aureus. There are approximately 150,000 patients suffering from EGFRi-induced skin toxicity in the United States.

The data in the oral presentations today showcase the preclinical development of ATR-04. ATR-04 led to a decrease in S. aureus across multiple models. In in vitro skin models, ATR-04 treatment led to a 96% reduction in methicillin-resistant S. aureus (MRSA) compared to untreated skin (p<0.0001). In ex vivo pig skin treated with ATR-04, there was a ~99% reduction in MRSA compared to untreated skin (p=0.012). Additionally, in human skin models treated with erlotinib, an EGFRi, ATR-04 reduced IL-36γ by 75% (p=0.009) to levels comparable to untreated skin models. Finally, ATR-04 increased human beta defensin, a key protein involved in host defenses, by 18-fold compared to vehicle. Together, the data show that ATR-04 can address multiple drivers of EGFRi-induced skin toxicity.