Azitra Expands ATR-04 Phase 1/2 Trial Eligibility to KRAS and MEK Inhibitor Rash
Azitra amended the Phase 1/2 trial of its ATR-04 candidate to include patients with rash caused by KRAS and MEK inhibitors and neurofibromatosis type 1 patients with MEK inhibitor-associated rash, and shortened washout periods for antibiotics and steroids. The filing says the changes broaden the potential treatment opportunities for ATR-04 and are intended to speed patient recruitment, but it gives no financial figures and no timeline for results.
Key points
- Eligibility now includes patients with rash associated with KRAS and MEK inhibitors, plus NF1 patients with MEK inhibitor-associated rash.
- Washout periods for antibiotics and steroids are shortened under the amendments.
- Cohort 2 is expected to enroll approximately 24 patients receiving once-daily treatment for 28 days, following the safety review committee's recommendation to proceed.
- Azitra cites about 85,000 U.S. patients a year on KRAS or MEK inhibitors, compared with about 220,000 on EGFR inhibitors.
The filing
Written by AI on Nov 9, 2026, 8:53 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on October 29, 2026.
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