Azitra Doses First Patient in Phase 1/2 Trial for ATR04-484 Skin Rash Treatment.

Azitra has dosed the first patient in its Phase 1/2 clinical trial of ATR04-484, a live biotherapeutic product candidate for EGFR inhibitor-associated rash. The FDA has granted Fast Track designation for this indication, which affects approximately 150,000 people in the US annually. ATR04-484 is part of Azitra's broader ATR-04 technology program.

Azitra, Inc. (NYSE American: AZTR), a clinical-stage biopharmaceutical company specializing in precision dermatology, has dosed the first patient in its Phase 1/2 clinical trial of ATR04-484, a live biotherapeutic product candidate designed to treat EGFR inhibitor (EGFRi)-associated rash. This milestone follows the FDA's Fast Track designation for the indication, which affects approximately 150,000 people in the U.S. annually [1].

The Phase 1/2 clinical trial (NCT06830863) is a multicenter, randomized, double-blind, vehicle-controlled study that aims to evaluate the safety and tolerability of topical ATR04-484 in adult patients. The trial will assess both safety and efficacy signals, including disease severity, pruritus, and pain. ATR04-484 is derived from a specially engineered Staphylococcus epidermidis strain designed to reduce IL-36γ and S. aureus levels, which are elevated in patients with EGFRi-associated skin rash [1].

The condition impacts 50-80% of cancer patients receiving EGFR inhibitors for cancers like non-small cell lung cancer (NSCLC) and colorectal cancer, often leading to significant physical and psychological discomfort. The papulopustular rash is the most common dermatologic adverse event, severely impacting quality of life and potentially interrupting or stopping cancer treatment [1].

Azitra's CEO, Francisco Salva, noted that "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" [1]. The Fast Track designation indicates regulatory recognition of the unmet medical need, potentially accelerating the regulatory pathway if promising data emerges.

The trial's robust design, with a 3:1 randomization ratio (ATR04-484 vs. vehicle), suggests a focus on collecting meaningful efficacy data while maintaining scientific rigor. The successful completion of this trial would establish the basis for continued clinical development of ATR04-484.

References:
[1] https://www.prnewswire.com/news-releases/azitra-inc-announces-first-patient-dosed-in-phase-12-trial-for-atr-04-program-targeting-oncology-patients-with-egfri-associated-rash-302539661.html