#None #Azitra #Branford #ATR-01 #Ichthyosis

Azitra, Inc. Showcases Groundbreaking ATR-01 Program for Ichthyosis Vulgaris at ASGCT 2026

Azitra, Inc., a clinical-stage biopharmaceutical company traded on NYSE American under the ticker symbol AZTR, recently announced a significant milestone for its advancements in dermatology. At the 2026 Annual Meeting of the American Society of Gene & Cell Therapy, Azitra presented fresh preclinical data from its innovative ATR-01 program, designed specifically for treating ichthyosis vulgaris (IV). This prevalent genetic skin disorder is characterized by a deficiency in filaggrin, a vital protein necessary for maintaining the skin's barrier function.

The presented research highlights the engineered live biotherapeutic candidate, ATR01-616, which aims to treat IV by delivering recombinant human filaggrin directly into the skin using a modified strain of Staphylococcus epidermidis. This novel approach not only addresses the condition's genetic basis but also enhances the skin's barrier function, a critical aspect for patients suffering from this chronic condition.

Data shared during the ASGCT meeting underscored ATR01-616's mechanism of action and its promising translational potential. Notably, it was shown to trigger the robust secretion of recombinant human filaggrin, with peak production occurring 6 to 8 hours after application. Experiments conducted on an ex vivo pig skin model revealed compelling results; ATR01-616 significantly decreased transepidermal water loss (TEWL) at all dosage levels (with a p-value of less than 0.001). Remarkably, these levels returned close to baseline after just 20 hours post-application. Moreover, studies involving reconstructed human epidermis illustrated a restoration of essential structural features, including increased filaggrin levels and the co-localization of filaggrin with keratin proteins, thereby reinforcing its integration into the skin barrier.

The insights derived from this preclinical study provide substantial backing for Azitra's ATR-01 program. “Our findings validate the potential of ATR-01 in addressing the root cause of ichthyosis vulgaris,” commented Francisco Salva, CEO of Azitra. He elaborated on how utilizing the skin's natural bacteria allows for deeper delivery of functional filaggrin domains into the epidermis, thus advancing a distinct therapeutic solution aimed at restoring skin barrier integrity. The data presented at ASGCT not only build on previously reported preclinical results for ATR-01 but also pave the way for future IND-enabling studies, leading towards human clinical trials for ichthyosis vulgaris patients.

The ATR01-616 formulation acts as a topical application that harnesses a genetically engineered strain of S. epidermidis, meticulously designed to function as an auxotroph for controlled growth while optimally secreting therapeutic filaggrin fragments. Such a model has the potential to overcome hurdles posed by existing treatments that fail to address the disease's biological underpinnings. This positions ATR-01 as an innovative microbiome-oriented treatment option in the dermatological landscape.

Presentation 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
• - Event: ASGCT 2026 Annual Meeting

About Azitra, Inc.

Azitra stands at the forefront of clinical-stage biopharmaceutical innovation, concentrating on the development of advanced therapies tailored for precision dermatology. The firm’s flagship development, ATR-12, is a pioneering regimen designed to combat Netherton syndrome—a rare chronic skin affliction currently lacking approved treatments. With a Phase 1b clinical trial underway for ATR-12 involving adult Netherton syndrome patients, Azitra aims to address unmet medical needs effectively. In addition, the company’s ATR-04 program focuses on alleviating rash associated with EGFR inhibitors, further highlighting its commitment to impactful dermatological therapies. Azitra harnesses proprietary technology in creating engineered proteins and topical live biotherapeutic products, supported by a sophisticated microbial library that encompasses around 1,500 bacterial strains. Cutting-edge artificial intelligence and machine learning enhance the development and screening processes within its microbial genetic engineering platform.

As Azitra continues its journey towards innovation, it is also targeting the consumer and cosmeceutical markets through proprietary filaggrin protein and peptide technologies, demonstrating a commitment to marrying therapeutic solutions with consumer needs. For more information, visit Azitra’s website.