Azitra, a biopharmaceutical company specializing in precision dermatology, has announced the FDA’s Fast Track Designation for ATR-04, a novel topical therapy for moderate to severe skin rashes associated with Epidermal Growth Factor Receptor inhibitors (EGFRi).
EGFR inhibitors, a common cancer treatment, often cause severe skin rashes, impacting patients’ quality of life. Current treatments include antibiotics, steroids, or discontinuing EGFRi therapy.
ATR-04 is a live biotherapeutic containing a modified Staphylococcus epidermidis strain. It targets the suppression of skin immunity and inflammation caused by EGFR inhibitors. The FDA’s Fast Track Designation recognizes the significant unmet need and potential of ATR-04.
The FDA’s Fast Track program expedites the development and review of promising therapies. This designation allows for more frequent FDA interactions and the possibility of accelerated approval if the treatment demonstrates clinical benefit.
Approximately 150,000 patients are affected by EGFRi-induced skin toxicity in the US, representing a significant market opportunity. Azitra plans to initiate a Phase 1/2 clinical trial in patients with EGFRi-associated dermal toxicity by the end of 2024.
The FDA’s Fast Track Designation for ATR-04 underscores the potential of this novel therapy to address the unmet medical need for EGFRi-associated skin rash. Azitra is committed to accelerating the development of ATR-04 to improve the lives of cancer patients experiencing this debilitating side effect.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
