TSX runs higher on rate cut expectations
Investing.com -- Azitra Inc (NYSE:AZTR) stock surged 67% premarket Wednesday after the clinical-stage biopharmaceutical company announced dosing of the first patient in its Phase 1/2 clinical trial of ATR04-484, a treatment candidate for EGFR inhibitor-associated rash.
The company’s topically applied live biotherapeutic product candidate is designed to address a condition that affects approximately 150,000 people annually in the U.S. The treatment has received Fast Track designation from the FDA, highlighting the unmet medical need in this area.
"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 study will evaluate the safety and tolerability of topical ATR04-484 for treating EGFRi-associated dermal toxicity affecting the face of adult patients. The trial will also assess efficacy signals including disease severity, pruritus, and pain.
EGFR inhibitors are targeted cancer therapies used to treat various tumor types including non-small cell lung cancer and colorectal cancer. However, these treatments frequently cause dermatologic side effects, with papulopustular rash occurring in 50-80% of patients. These side effects can be severe enough to interrupt or discontinue cancer treatment.
ATR04-484 is derived from a naturally occurring Staphylococcus epidermidis strain and was selected based on its preclinical profile of reducing IL-36γ and S. aureus levels, both of which are elevated in patients with EGFRi-associated skin rash.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.