Azitra Inc. (NYSE American: AZTR) has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to ATR-04, a topically applied therapy for moderate to severe skin rash associated with Epidermal Growth Factor Receptor (EGFR) inhibitors. This designation aims to expedite the development and review of ATR-04, addressing a significant unmet need for cancer patients experiencing debilitating skin toxicity. The company plans to initiate a Phase I/II clinical trial by the end of 2024.
Addressing EGFRi-Associated Skin Toxicity
EGFR inhibitors, commonly used in cancer treatment, often cause significant skin rashes as a side effect. These rashes can lead to off-label treatments with antibiotics, steroids, or other medications, and in some cases, discontinuation of EGFRi therapy. According to Azitra, approximately 150,000 patients in the U.S. suffer from EGFRi-induced skin toxicity, representing a market opportunity exceeding $1 billion. The skin toxicity significantly impacts patients' quality of life, creating a substantial burden.
"We are thrilled to announce the FDA has granted Fast Track designation to ATR-04, demonstrating that the FDA recognizes the unmet need for treatment of EGFRi-associated skin rash," said Francisco Salva, CEO of Azitra. "We look forward to potentially accelerating the development of ATR-04 to treat this condition."
Mechanism of Action and Clinical Development
ATR-04 is a live biotherapeutic product containing a genetically modified strain of Staphylococcus epidermidis. The modifications are designed to enhance safety by removing an antibiotic resistance gene and controlling bacterial growth through auxotrophy. The treatment aims to address the underlying cause of EGFRi-associated skin rash, which involves suppression of skin immunity, inflammation, and elevated levels of IL-36γ and S. aureus.
The FDA's Fast Track program is designed to facilitate the development and expedite the review of new therapies that target serious conditions and fill unmet medical needs. Benefits of this designation include more frequent interactions with the FDA and the possibility of accelerated approval or rolling review.
Azitra is preparing to launch a multicenter, randomized, controlled Phase I/II clinical trial of ATR-04 by the end of 2024. This trial will focus on patients experiencing dermal toxicity due to EGFR inhibitors, further evaluating the efficacy and safety of the treatment.
Azitra's Platform Technology
Azitra leverages a proprietary platform that includes a microbial library with approximately 1,500 unique bacterial strains. This platform utilizes artificial intelligence and machine learning to screen for therapeutic characteristics and drug-like molecules, enhancing the development of precision dermatology therapies.
