Azitra (AZTR) expanded eligibility in its ongoing Phase 1/2 ATR04-484 trial to include patients with KRAS and MEK inhibitor-associated rash. The amendments also include patients with neurofibromatosis type 1 who have MEK inhibitor-associated rash, extending enrollment beyond the trial's initial focus on epidermal growth factor receptor inhibitor-associated rash.The protocol shortens required washout periods for antibiotics and steroids; Azitra expects the changes to facilitate recruitment and accelerate enrollment. The multicenter, randomized, double-blind, vehicle-controlled study evaluates topical ATR04-484's safety, tolerability, bioavailability, biological effects and preliminary efficacy. Its safety review committee recommended proceeding to Cohort 2 after reviewing available Cohort 1 safety data. Cohort 2 is expected to enroll approximately 24 patients, receiving once-daily treatment for 28 days.

Reported Thursday, Oct 1 - 8:02am EDT (TheFly subscription required to read more.)

Azitra, Inc. ("Azitra") (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today reported financial results for the...

Azitra, Inc. ("Azitra") (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today announced the dosing of the first ...

Azitra, Inc. (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today announced that it will present a poster descr...

Azitra, Inc. (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today reported financial results for the quarter en...

Azitra, Inc. (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today reported financial results for the full year ...

Reported Wednesday, Aug 27 - 8:13am EDT (TheFly subscription required to read more.)

Azitra, Inc. has initiated its Phase 1/2 trial for ATR04-484, targeting skin rashes associated with EGFR inhibitors, addressing a crucial need in oncology.

Azitra, Inc. presents promising results on ATR04-484 targeting EGFR inhibitor-associated rash at ASGCT 2025, showcasing innovative cancer therapy.

Azitra (NYSE American: AZTR) has initiated dosing in a Phase 1/2 clinical trial for ATR04-484, a topical live biotherapeutic treatment targeting EGFR inhibitor (EGFRi)-associated rash. The condition affects approximately 150,000 people annually in the U.S. and has received FDA Fast Track designation.The multicenter, randomized, double-blind, vehicle-controlled study (NCT06830863) will evaluate ATR04-484's safety and tolerability in adult patients. The treatment addresses a critical medical need, as EGFRi-associated rash affects 50-80% of cancer patients receiving EGFR inhibitor treatments, often leading to cancer treatment interruption or discontinuation.ATR04-484 is derived from a specially engineered Staphylococcus epidermidis strain, designed to reduce IL-36γ and S. aureus levels, which are elevated in affected patients.

Novel biologic ATR04-484 targets severe skin rash that forces cancer patients off treatment. FDA Fast Track designated therapy debuts Phase 1/2 data. Learn more.

Azitra plans to dose first patient in a Phase 1/2 trial in the first half of 2025 for its precision dermatology candidate ATR04-484, designed for the treatment of EGFR inhibitor-associated rash BRANFORD, Conn., May 14, 2025 /PRNewswire/ -- Azitra, Inc. (NYSE American: AZTR), a clinical...