Azitra Granted Fast Track for ATR-04 for EGFR Inhibitor Skin Rash

Azitra, Inc., a clinical-stage biopharmaceutical company specializing in precision dermatology, has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for its topically applied product ATR-04. This product is aimed at treating moderate to severe dermal toxicity associated with Epidermal Growth Factor Receptor inhibitors (EGFRi). EGFR inhibitors are commonly used in cancer treatment but often lead to significant side effects such as severe skin rashes, necessitating off-label treatments or discontinuation of EGFRi therapy.

Francisco Salva, the CEO of Azitra, expressed excitement over the FDA's recognition of the need for effective treatments for EGFRi-induced skin toxicity. He highlighted the severe impact these skin conditions have on the quality of life for cancer patients. The Fast Track Designation underscores the urgency and importance of developing ATR-04 as a potential treatment for this condition.

The FDA's Fast Track program is designed to expedite the development and review of drugs that treat serious conditions and address unmet medical needs. Fast Track status can provide benefits such as more frequent meetings with the FDA and eligibility for accelerated approval or rolling review. These advantages could potentially speed up the availability of ATR-04 to patients in need.

ATR-04 is a live biotherapeutic product candidate consisting of a specially engineered strain of Staphylococcus epidermidis. This strain has been modified to enhance safety by removing an antibiotic resistance gene and incorporating auxotrophy to control its growth. The product is being developed to combat EGFRi-associated skin rash, which arises from suppressed skin immunity and subsequent inflammation, often accompanied by elevated levels of IL-36γ and Staphylococcus aureus. In the United States alone, approximately 150,000 patients suffer from EGFRi-induced skin toxicity, representing a market opportunity exceeding $1 billion.

Azitra intends to launch a multicenter, randomized, controlled Phase 1/2 clinical trial of ATR-04 in patients with EGFRi-induced dermal toxicity by the end of 2024. This trial will be crucial in determining the safety and efficacy of ATR-04 in a clinical setting.

Azitra, Inc. is dedicated to developing innovative therapies for precision dermatology. The company employs engineered proteins and topical live biotherapeutic products. Its proprietary platform includes a microbial library of around 1,500 unique bacterial strains, which can be screened for therapeutic characteristics. This platform is enhanced by artificial intelligence and machine learning technologies that help in analyzing and predicting the potential of these strains. The company's primary focus is on genetically engineered strains of Staphylococcus epidermidis, which is considered an optimal species for dermatologic therapy development.

In summary, the FDA's Fast Track Designation for ATR-04 marks a significant milestone for Azitra, potentially accelerating the treatment options for patients suffering from EGFRi-associated skin toxicity. With the planned clinical trials, Azitra is poised to further validate the efficacy of ATR-04 and bring innovative solutions to the field of precision dermatology.