Azitra Inc (AMEX:AZTR) stock jumped 67% in premarket trading Wednesday following the announcement that the first patient has been dosed in the Phase 1/2 trial for ATR04-484, a potential treatment for EGFR inhibitor-associated rash.
The candidate, a topical live biotherapeutic, aims to treat a condition affecting roughly 150,000 people annually in the U.S. It has received Fast Track designation from the FDA, reflecting the significant unmet medical need.
“Dosing the first patient is an important milestone in the advancement of ATR04-484 as a potential treatment for EGFRi associated rash and in the development of our broader ATR-04 technology program,” said Francisco Salva, CEO of Azitra.
The multicenter, randomized, double-blind, vehicle-controlled trial will evaluate the safety and tolerability of topical ATR04-484 in adults experiencing EGFRi-related skin toxicity on the face. Researchers will also monitor efficacy signals, including disease severity, pruritus, and pain.
EGFR inhibitors, commonly used in treating cancers such as non-small cell lung cancer and colorectal cancer, frequently cause dermatologic side effects, with papulopustular rash appearing in 50-80% of patients. These side effects can be severe enough to require treatment interruption or discontinuation.
ATR04-484 is derived from a naturally occurring Staphylococcus epidermidis strain, chosen for its preclinical ability to reduce IL-36γ and S. aureus levels, both of which are elevated in patients with EGFRi-associated skin rash.
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