On April 28, 2026 Azitra, Inc. (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, reported the presentation of new preclinical data from its ATR-01 program at the 2026 Annual Meeting of the American Society of Gene & Cell Therapy ("ASGCT 2026").
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The poster highlights Azitra’s engineered live biotherapeutic candidate ATR01-616, which is designed to treat ichthyosis vulgaris (IV) by delivering recombinant human filaggrin directly into the skin using a modified Staphylococcus epidermidis strain. IV is a common genetic skin disorder caused by filaggrin deficiency, leading to impaired skin barrier function and increased trans-epidermal water loss (TEWL).
The data being presented at ASGCT (Free ASGCT Whitepaper) 2026 highlight ATR01-616’s mechanism of action and translational potential, including its ability to elicit robust secretion of a recombinant human filaggrin domain, with peak production observed 6–8 hours following application. In an ex vivo pig skin model, ATR01-616 significantly reduced transepidermal water loss across all dose levels (p < 0.001), with levels returning near baseline within 20 hours. In parallel, studies in reconstructed human epidermis showed restoration of key structural features such as increased filaggrin levels and co-localization with keratin proteins, supporting functional integration into the skin barrier.
"These data provide compelling validation of our ATR-01 program and its potential to address the underlying cause of ichthyosis vulgaris," said Francisco Salva, Chief Executive Officer of Azitra. "By using the skin’s natural bacteria to deliver functional filaggrin domains deeper into the epidermis, we are advancing a differentiated approach designed to restore skin barrier function and target the protein to where it is needed to address this genetically driven disease. The findings presented at ASGCT (Free ASGCT Whitepaper) build on our previously reported positive preclinical data for ATR-01 and further support the program’s advancement toward IND-enabling studies and a first-in-human clinical trial in patients with ichthyosis vulgaris."
ATR01-616 is a topical formulation containing a genetically engineered S. epidermidis strain designed as an auxotroph for controlled growth and optimized to secrete therapeutic filaggrin fragments. This approach enables localized, sustained delivery of protein therapeutics directly to affected skin, potentially overcoming limitations of existing treatments that do not address underlying disease biology and positioning ATR-01 as a novel, microbiome-based modality within dermatology.
Poster Details
Title: An Engineered Human Filaggrin Secreting Staphylococcus epidermidis Strain for the Topical Treatment of Ichthyosis Vulgaris
Presenter: Roger Léger, Ph.D., Vice President of Chemistry, Formulation and Development, Azitra, Inc.
Abstract Number: 2691
Session: Gene Addition: Non-Viral Vectors
Meeting: ASGCT (Free ASGCT Whitepaper) 2026 Annual Meeting
(Press release, Azitra, APR 28, 2026, View Source [SID1234664850])