Azitra, Inc. Reports Promising Preclinical Results for ATR-01 Solution Aiming to Address Ichthyosis Vulgaris

Promising Developments at Azitra, Inc. for ATR-01

Azitra, Inc., a biopharmaceutical firm that specializes in precision dermatology, recently announced optimistic preclinical findings for its ATR-01 program aimed at treating ichthyosis vulgaris. This condition, characterized by dry and scaly skin, affects around 1.3 million individuals in the United States alone, with no established treatment options available aside from symptom management.

The exciting updates about ATR-01 will be revealed during a virtual presentation at the BIO-Europe® conference, scheduled to take place from November 3rd to 5th, 2025, in Vienna, Austria. At the helm of the presentation will be Travis Whitfill, PhD, MPH, one of Azitra's co-founders and its Chief Operating Officer. An essential aspect of the ATR-01 program is the utilization of a specific bacterial strain, S. epidermidis, engineered to release a form of human filaggrin protein. This protein plays a crucial role in skin barrier function and hydration.

The preclinical data indicates that the engineered strain, identified as ATR01-616, performs remarkably in several model tests. In experimental settings, this strain successfully secreted functional filaggrin, as highlighted by keratin binding assays—showing its effective role in skin treatment. Furthermore, fluorescence immunohistochemistry revealed that ATR01-616 was able to transport filaggrin through the skin barrier, crucial for addressing the underlying pathophysiology of ichthyosis vulgaris. Notably, a significant decrease in transepidermal water loss was observed using a damaged pig skin model, a crucial metric for assessing skin repair and function.

“We're excited to showcase these positive preclinical results during BIO-EUROPE as we prepare for clinical trials,” emphasized Francisco Salva, CEO of Azitra. The disease’s predominant effects and the insufficiency of current treatment avenues further underline the importance of ATR-01. Patients suffering from ichthyosis vulgaris experience profound impacts on their quality of life due to the condition's chronic nature.

As part of its presentation, Dr. Whitfill will not only highlight ATR-01’s progress but will also share updates on two other clinical initiatives, ATR-12 and ATR-04. The ATR-12 program targets Netherton syndrome, an exceptionally rare skin condition. This program is currently in a Phase 1b clinical trial involving adult patients. On the other hand, ATR-04 focuses on addressing skin rashes related to EGFR inhibitors, with an FDA Fast Track designation to speed up its development as there are approximately 150,000 individuals affected in the United States.

The future looks bright for Azitra and its innovative approach to treating skin diseases. As they aim for human clinical trials of ATR-01 in the coming years, the potential for a therapeutic breakthrough in the treatment landscape of ichthyosis vulgaris is promising.

In conclusion, Azitra’s leading-edge platform, which includes a library of around 1,500 bacterial strains bolstered by artificial intelligence and machine learning technologies, allows for the development of targeted therapies designed to tackle intricate dermatological conditions effectively. With the anticipated IND submissions in 2026, many are hopeful that these advancements bring new relief to patients afflicted with this debilitating condition.

For more information about Azitra and its groundbreaking work, visitors can explore their website at (https://azitrainc.com).