Azitra has broadened its Phase 1/2 trial of topical ATR04-484 to include patients with skin rashes linked to KRAS and MEK inhibitor cancer drugs, as well as people with neurofibromatosis type 1 (NF1) who develop rashes while taking MEK inhibitors. The company also shortened required waiting periods after antibiotic and steroid use, changes it expects to make recruitment easier.
The amendments expand the conditions being studied beyond rashes associated with EGFR inhibitors. They do not represent new clinical results: the trial is still evaluating the treatment’s safety and preliminary efficacy.
Key details
- The multicenter, randomized, double-blind, vehicle-controlled study is assessing ATR04-484’s safety, tolerability, bioavailability, pharmacodynamic effects and preliminary efficacy.
- The expanded eligibility covers rashes associated with KRAS and MEK inhibitors, including MEK inhibitor-related rashes in patients with NF1.
- Azitra says approximately 85,000 people in the United States receive KRAS or MEK inhibitor treatment each year. About 220,000 receive EGFR inhibitor treatment annually. The company has cited up to 300,000 U.S. patients affected each year by cancer-treatment-associated rash.
- NF1 is a rare genetic disorder involving tumors along nerves; Azitra estimates it affects about 100,000 people in the United States.
- The broader eligibility follows a safety review committee’s recommendation to advance the study to Cohort 2 after reviewing available Cohort 1 data. Cohort 2 is expected to enroll about 24 patients, who will receive once-daily treatment for 28 days.
- ATR04-484 is a live biotherapeutic candidate based on a naturally derived Staphylococcus epidermidis strain. Azitra selected it for preclinical characteristics including reductions in the inflammatory cytokine IL-36γ and Staphylococcus aureus levels. The strain was engineered to remove an antibiotic-resistance gene and to limit its growth.
- The FDA has granted ATR04-484 Fast Track designation for cancer-treatment-associated rash.
What changes for the program
The trial will now examine ATR04-484 across a wider range of treatment-related rashes, including those associated with KRAS and MEK inhibitors, rather than focusing only on EGFR inhibitor-associated rash. Shorter antibiotic and steroid washout periods also reduce restrictions on who can enroll. The study remains an early-stage evaluation; the announcement provided no new efficacy findings.