Clinical trialsCompany release

Azitra extends ATR04-484 trial to KRAS and MEK inhibitor rash, including NF1 patients

🇺🇸 Azitra, Inc. (AZTR) · Thu 29 Oct 2026

The US biotech has amended its Phase 1/2 study of the topical live biotherapeutic beyond EGFR inhibitor rash and shortened antibiotic and steroid washout periods to ease recruitment.

Azitra, Inc. has amended the protocol of its Phase 1/2 trial (NCT06830863) of ATR04-484, a topical live biotherapeutic, so that it can enrol patients with rash caused by KRAS and MEK inhibitors. The amendment was announced on 29 October 2026.

The study was originally focused on rash associated with EGFR inhibitors. Under the revised eligibility criteria, the population now also covers people with neurofibromatosis type 1 (NF1) who are being treated with MEK inhibitors.

The amendments also shorten the washout periods required for antibiotics and steroids before enrolment. Azitra's stated aim is to make recruitment easier.

The changes follow a recommendation from the trial's safety review committee to advance to Cohort 2. ATR04-484 holds US FDA Fast Track designation for rash associated with cancer treatment. The source material provided does not give further details on dosing, cohort size or timelines.

What it means for your team

  • Sponsors running supportive-care trials in oncology may see broader eligibility as a way to speed recruitment, but pooling different inhibitor classes can complicate safety and efficacy interpretation.
  • Pharmacovigilance teams should note that the study population now spans EGFR, KRAS and MEK inhibitor rash, which widens the range of background oncology therapies in the safety dataset.
  • Shorter antibiotic and steroid washouts change the baseline conditions of participants, a point reviewers may consider when assessing future data.
  • The safety review committee's recommendation to proceed to Cohort 2 is the key safety checkpoint reported so far.

Company's press release (SEC filing): Azitra, Inc. ↗

Article written by VigiEye from the official source (Azitra, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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