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Azitra, Inc. Expands Eligibility for ATR-04 Phase 1/2 Clinical Trial to Include Patients with Rashes due to KRAS and MEK Inhibitors

AZTR
  • Azitra amended its Phase 1/2 clinical trial (NCT06830863) for ATR04-484 to expand eligibility beyond EGFR inhibitor-associated rash to include patients with rash from KRAS and MEK inhibitors.
  • The expanded criteria now include patients with neurofibromatosis type 1 (NF1) experiencing rash associated with MEK inhibitors.
  • Protocol modifications shorten required washout periods for antibiotics & steroids to facilitate patient recruitment & accelerate enrollment.
  • A safety review committee recommended proceeding to Cohort 2, which will enroll approximately 24 patients receiving once-daily treatment for 28 days.
  • Approximately 85,000 patients in the U.S. annually undergo KRAS or MEK inhibitor treatment, while 220,000 undergo EGFR inhibitor treatment.
  • ATR04-484 is a live biotherapeutic product derived from Staphylococcus epidermidis designed to reduce pro-inflammatory cytokine IL-36γ & Staphylococcus aureus levels.
  • The FDA has granted Fast Track designation to ATR04-484 for cancer treatment-associated rash, targeting up to 300,000 affected patients annually in the U.S.
  • The strain was engineered with an antibiotic resistance gene deletion & auxotrophy to control growth & improve safety profiles.