Azitra, Inc. Announces First Patient Dosed in Phase 1/2 Trial for ATR-04 Program Targeting Oncology Patients with EGFRi-Associated Rash
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.
Azitra (NYSE American: AZTR) ha iniziato la somministrazione in uno studio clinico di fase 1/2 per ATR04-484, un trattamento topico a base di microrganismi vivi mirato alla eruzione cutanea associata agli inibitori di EGFR (EGFRi). La condizione interessa circa 150.000 persone all'anno negli Stati Uniti e ha ottenuto la designazione Fast Track dalla FDA.
Lo studio multicentrico, randomizzato, in doppio cieco e controllato con veicolo (NCT06830863) valuterà la sicurezza e la tollerabilità di ATR04-484 in pazienti adulti. Il trattamento risponde a un bisogno medico importante, dato che l'eruzione cutanea correlata agli EGFRi colpisce il 50-80% dei pazienti oncologici trattati con inibitori di EGFR, spesso causando interruzioni o sospensioni della terapia antitumorale.
ATR04-484 deriva da un ceppo appositamente ingegnerizzato di Staphylococcus epidermidis, progettato per ridurre i livelli di IL-36γ e di S. aureus, aumentati nei pazienti colpiti.
Azitra (NYSE American: AZTR) ha comenzado la dosificación en un ensayo clínico de fase 1/2 para ATR04-484, un tratamiento tópico con bioterapéuticos vivos dirigido a la erupción asociada a inhibidores de EGFR (EGFRi). La afección afecta aproximadamente a 150.000 personas al año en EE. UU. y ha recibido la designación Fast Track de la FDA.
El estudio multicéntrico, aleatorizado, doble ciego y controlado con vehículo (NCT06830863) evaluará la seguridad y tolerabilidad de ATR04-484 en pacientes adultos. Este tratamiento cubre una necesidad médica crítica, ya que la erupción asociada a EGFRi afecta al 50-80% de los pacientes con cáncer que reciben inhibidores de EGFR, frecuentemente provocando la interrupción o suspensión del tratamiento oncológico.
ATR04-484 se obtiene de una cepa especialmente diseñada de Staphylococcus epidermidis, concebida para reducir los niveles de IL-36γ y de S. aureus, que están elevados en los pacientes afectados.
Azitra (NYSE American: AZTR)는 EGFR 억제제(EGFRi) 관련 발진을 표적으로 하는 국소용 생균 치료제 ATR04-484의 1/2상 임상시험에서 투약을 시작했습니다. 이 상태는 미국에서 연간 약 150,000명에게 영향을 미치며 FDA의 패스트트랙 지정을 받았습니다.
다기관, 무작위배정, 이중맹검, 제형 대조 연구(NCT06830863)는 성인 환자에서 ATR04-484의 안전성 및 내약성을 평가할 예정입니다. 이 치료제는 중요한 의료적 필요를 충족합니다. EGFRi 관련 발진은 EGFR 억제제를 받는 암 환자의 50-80%에 발생하여 치료 중단이나 중지를 초래하는 경우가 많습니다.
ATR04-484은 특수하게 설계된 Staphylococcus epidermidis 균주에서 유래했으며, 영향을 받은 환자에서 상승해 있는 IL-36γ와 S. aureus 수준을 낮추도록 고안되었습니다.
Azitra (NYSE American: AZTR) a commencé les administrations dans un essai clinique de phase 1/2 pour ATR04‑484, un traitement topique à base de biothérapeutiques vivants visant l’éruption cutanée associée aux inhibiteurs d’EGFR (EGFRi). Cette affection touche environ 150 000 personnes par an aux États‑Unis et a obtenu la désignation Fast Track de la FDA.
L’étude multicentrique, randomisée, en double aveugle et contrôlée par véhicule (NCT06830863) évaluera la sécurité et la tolérabilité d’ATR04‑484 chez des patients adultes. Ce traitement répond à un besoin médical majeur, puisque l’éruption liée aux EGFRi touche 50–80 % des patients atteints de cancer traités par inhibiteurs d’EGFR, entraînant souvent l’interruption ou l’arrêt du traitement anticancéreux.
ATR04‑484 est dérivé d’une souche spécialement modifiée de Staphylococcus epidermidis, conçue pour réduire les niveaux d’IL‑36γ et de S. aureus, qui sont élevés chez les patients concernés.
Azitra (NYSE American: AZTR) hat mit der Dosierung in einer Phase‑1/2‑Studie für ATR04‑484 begonnen, einem topischen Live‑Biotherapeutikum zur Behandlung von EGFR‑Inhibitor (EGFRi)‑assoziiertem Hautausschlag. Die Erkrankung betrifft in den USA jährlich etwa 150.000 Personen und erhielt die Fast‑Track‑Zulassung der FDA.
Die multizentrische, randomisierte, doppelblinde, vehicle‑kontrollierte Studie (NCT06830863) wird die Sicherheit und Verträglichkeit von ATR04‑484 bei erwachsenen Patientinnen und Patienten untersuchen. Der Ansatz deckt einen wichtigen medizinischen Bedarf ab, da der EGFRi‑assoziierte Ausschlag 50–80 % der Krebspatienten betrifft, die EGFR‑Inhibitoren erhalten, und häufig zu Unterbrechung oder Abbruch der Krebstherapie führt.
ATR04‑484 basiert auf einem speziell entwickelten Stamm von Staphylococcus epidermidis, der darauf ausgelegt ist, erhöhte IL‑36γ‑ und S. aureus‑Werte bei betroffenen Patienten zu reduzieren.
- FDA Fast Track designation received for EGFRi-associated rash treatment
- Large addressable market of 150,000 patients annually in the U.S.
- Treatment addresses critical unmet medical need affecting 50-80% of cancer patients on EGFRi therapy
- None.
Insights
Azitra's first patient dosed in Phase 1/2 trial for ATR04-484 marks early clinical progress addressing significant EGFRi rash affecting 150,000 cancer patients annually.
Azitra has reached a significant clinical milestone with the first patient dosed in its Phase 1/2 trial of ATR04-484, a topical live biotherapeutic product candidate targeting EGFR inhibitor-associated rash. This development carries particular significance as the program has already secured FDA Fast Track designation, indicating regulatory recognition of the unmet medical need.
The market opportunity is substantial with approximately
From a clinical perspective, the trial design is robust - a multicenter, randomized, double-blind, vehicle-controlled study evaluating both safety and efficacy signals including disease severity, pruritus, and pain. The 3:1 randomization ratio (ATR04-484 vs. vehicle) suggests a focus on collecting meaningful efficacy data while maintaining scientific rigor.
The product's mechanism appears scientifically sound, utilizing a naturally derived Staphylococcus epidermidis strain engineered for safety and targeting elevated IL-36γ and S. aureus levels in affected patients. This approach addresses the specific pathophysiology of EGFR inhibitor-associated dermatologic toxicities rather than merely providing symptomatic relief.
While this represents early-stage clinical development, the Fast Track designation could potentially accelerate the regulatory pathway if promising data emerges. The successful completion of this trial would establish the foundation for continued clinical development addressing a clearly defined medical need that directly impacts cancer treatment outcomes.
BRANFORD, Conn., Aug. 27, 2025 /PRNewswire/ -- 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 patient in its Phase 1/2 clinical trial of ATR04-484, a topically applied live biotherapeutic product candidate designed to treat EGFR inhibitor ("EGFRi")-associated rash. Azitra has received Fast Track designation from the FDA for EGFRi associated rash, which impacts approximately 150,000 people in the
"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. "Given the importance of EGFRi treatments across multiple cancers, there is a critical medical need to reduce the impact of the unique dermatologic toxicities that often accompany EGFRi treatments, often leading to interruption or discontinuation of the treatment. This trial is a first step in ATR04-484 potentially addressing this patient need and market opportunity."
Targeted cancer therapies, like EGFRis, have produced significant treatment advances for patients diagnosed with a variety of tumor types including non-small cell lung cancer (NSCLC) and colorectal cancer, but they are also associated with unique dermatologic toxicities. These side effects can severely hamper treatment efforts, causing significant physical and psychological discomfort for patients. The papulopustular rash is often the earliest and most common dermatologic adverse event of EGFRi treatment and can occur in 50
The multicenter, randomized, double-blind, vehicle-controlled Phase 1/2 clinical study (NCT06830863) is designed to evaluate the safety and tolerability of topical ATR04-484 for the treatment of EGFRi-associated dermal toxicity affecting the face of adult patients. ATR04-484 or its vehicle (3:1 randomization) will be applied to the face as well as affected areas on the neck, chest, back, and areas around nailbeds. The key objectives of the study will be to assess the safety and tolerability of topical ATR04-484 and to evaluate efficacy signals including severity of disease, pruritus, and pain. The bioavailability of ATR04-484 and pharmacodynamic parameters will also be studied. This clinical study will establish the basis for continued clinical development of ATR04-484.
ATR04-484 is a live biotherapeutic product candidate including an isolated, naturally derived Staphylococcus epidermidis strain in development for EGFRI-associated skin rash. The candidate 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. The strain was then engineered to be safe by deleting an antibiotic resistance gene and engineering auxotrophy to control the growth of ATR04-484.
About Azitra, Inc.
Azitra, Inc. is a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology. Azitra's lead program, ATR-12, uses an engineered strain of S. epidermidis designed to treat Netherton syndrome, a rare, chronic skin disease with no approved treatment options. Netherton syndrome may be fatal in infancy with those living beyond a year having profound lifelong challenges. The ATR-12 program includes a Phase 1b clinical trial in adults with Netherton syndrome. ATR-04, Azitra's additional clinical program, utilizes another engineered strain of S. epidermidis for the treatment of EGFR inhibitor ("EGFRi") associated skin toxicity; a Phase 1/2 clinical trial has been initiated for this program. Azitra has received Fast Track designation from the FDA for this program to treat EGFRi associated rash, which impacts approximately 150,000 people in
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will," and variations of these words or similar expressions that are intended to identify forward-looking statements. Any such statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements include, without limitation, statements regarding the expected timing of our provision of safety data and topline results for the Phase 1b trial for our ATR-12 program, the expected timing of any additional dosing in the Phase 1/2 clinical trial for our ATR-04 program, the expected timing of any other dosing or release of data, our clinical and preclinical programs, and corporate and clinical/preclinical strategies.
Any forward-looking statements in this press release are based on current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to that we may experience delays in the provision of topline results for studies of ATR-12 or ATR-04 programs, or that such data may not be favorably received; we may experience delays in dosing patients in our clinical trials; our product candidates may not be effective; there may be delays in regulatory approval or changes in regulatory framework that are out of our control; our estimation of addressable markets of our product candidates may be inaccurate; we may fail to timely raise additional required funding; more efficient competitors or more effective competing treatment may emerge; we may be involved in disputes surrounding the use of our intellectual property crucial to our success; we may not be able to attract and retain key employees and qualified personnel; earlier study results may not be predictive of later stage study outcomes; and we are dependent on third-parties for some or all aspects of our product manufacturing, research and preclinical and clinical testing. Additional risks concerning Azitra's programs and operations are described or incorporated by reference in our annual report on Form 10-K filed with the SEC on February 24, 2025, and our subsequent quarterly reports on Form 10-Q. Azitra explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.
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staskey@azitrainc.com
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FAQ
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