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.
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