Azitra Receives Fast Track Designation for ATR-04 for Skin Rash from EGFR Inhibitors
Azitra (NYSE American: AZTR) has received Fast Track Designation from the FDA for ATR-04, a topical treatment for moderate to severe skin rash caused by Epidermal Growth Factor Receptor inhibitors (EGFRi). This designation recognizes the unmet medical need for treating EGFRi-associated dermal toxicity, which affects approximately 150,000 patients in the US, representing a $1 billion market opportunity.
ATR-04 is a live biotherapeutic product containing an engineered Staphylococcus epidermidis strain. Azitra plans to initiate a Phase 1/2 clinical trial by the end of 2024. The Fast Track status may accelerate ATR-04's development and review process, potentially offering cancer patients a much-needed alternative to current off-label treatments or therapy discontinuation.
Azitra (NYSE American: AZTR) ha ricevuto la Designazione di Percorso Accelerato dalla FDA per ATR-04, un trattamento topico per eruzioni cutanee da moderate a severe causate dagli inibitori del recettore del fattore di crescita epidermico (EGFRi). Questa designazione riconosce il bisogno medico insoddisfatto per trattare la tossicità dermica associata agli EGFRi, che colpisce circa 150.000 pazienti negli Stati Uniti, rappresentando un opportunità di mercato da 1 miliardo di dollari.
ATR-04 è un prodotto bioterapico vivo contenente un ceppo ingegnerizzato di Staphylococcus epidermidis. Azitra prevede di avviare un studio clinico di fase 1/2 entro la fine del 2024. Lo status di Percorso Accelerato potrebbe accelerare lo sviluppo e il processo di revisione di ATR-04, offrendo potenzialmente ai pazienti oncologici un'alternativa molto necessaria ai trattamenti attuali off-label o alla sospensione della terapia.
Azitra (NYSE American: AZTR) ha recibido la Designación de Vía Rápida de la FDA para ATR-04, un tratamiento tópico para erupciones cutáneas de moderadas a severas causadas por inhibidores del receptor del factor de crecimiento epidermal (EGFRi). Esta designación reconoce la necesidad médica no satisfecha para tratar la toxicidad dérmica asociada a los EGFRi, que afecta aproximadamente a 150.000 pacientes en los Estados Unidos, representando una oportunidad de mercado de 1.000 millones de dólares.
ATR-04 es un producto bioterapéutico vivo que contiene una cepa de Staphylococcus epidermidis modificada. Azitra planea iniciar un ensayo clínico de fase 1/2 para finales de 2024. El estatus de Vía Rápida podría acelerar el desarrollo y el proceso de revisión de ATR-04, ofreciendo potencialmente a los pacientes con cáncer una alternativa muy necesaria a los tratamientos actuales fuera de indicación o la interrupción de la terapia.
Azitra(NYSE American: AZTR)는 EGFR 억제제(EGF-Ri)로 인한 중증 및 심각한 피부 발진에 대한 국소 치료제 ATR-04에 대해 FDA로부터 신속 승인 자격을 받았습니다. 이 자격은 EGFRi와 관련된 피부 독성 치료에서의 충족되지 않은 의료 필요성을 인정하며, 이는 미국에서 약 150,000명의 환자에게 영향을 미치며 10억 달러 규모의 시장 기회를 제공합니다.
ATR-04는 조작된 Staphylococcus epidermidis 균주를 포함한 생물학적 치료 제품입니다. Azitra는 2024년 말까지 1/2상 임상 시험을 시작할 계획입니다. 신속 승인 지위는 ATR-04의 개발 및 리뷰 프로세스를 가속화하여, 암 환자들에게 현재의 비적응 치료나 요법 중단에 대한 매우 필요한 대안을 제공할 수 있습니다.
Azitra (NYSE American: AZTR) a reçu de la FDA la désignation de voie rapide pour ATR-04, un traitement topique pour les éruptions cutanées modérées à sévères causées par les inhibiteurs du récepteur du facteur de croissance épidermique (EGFRi). Cette désignation reconnaît le besoin médical non satisfait pour traiter la toxicité cutanée associée aux EGFRi, qui affecte environ 150 000 patients aux États-Unis, représentant une opportunité de marché d'un milliard de dollars.
ATR-04 est un produit biothérapeutique vivant contenant une souche de Staphylococcus epidermidis modifiée. Azitra prévoit de lancer un essai clinique de phase 1/2 d'ici la fin de 2024. Le statut de voie rapide pourrait accélérer le développement et le processus d'examen d'ATR-04, offrant ainsi aux patients atteints de cancer une alternative très attendue aux traitements actuels hors indication ou à l'interruption de la thérapie.
Azitra (NYSE American: AZTR) hat von der FDA die Schnellverfahrens-Zulassung für ATR-04 erhalten, eine topische Behandlung für moderaten bis schweren Hautausschlag, der durch Epidermal Growth Factor Receptor-Inhibitoren (EGFRi) verursacht wird. Diese Zulassung erkennt den unerfüllten medizinischen Bedarf zur Behandlung der EGFRi-assoziierten Hauttoxizität an, die rund 150.000 Patienten in den USA betrifft und eine Marktmöglichkeit von 1 Milliarde Dollar darstellt.
ATR-04 ist ein lebend-biotherapeutisches Produkt, das einen genetisch veränderten Staphylococcus epidermidis-Stamm enthält. Azitra plant, bis Ende 2024 eine Phase 1/2-Studie zu starten. Der Schnellverfahrensstatus könnte die Entwicklung und den Überprüfungsprozess von ATR-04 beschleunigen und Patienten mit Krebs eine dringend benötigte Alternative zu aktuellen Off-Label-Behandlungen oder einem Therapieabbruch bieten.
- FDA granted Fast Track Designation for ATR-04, potentially accelerating development and review
- ATR-04 addresses an unmet medical need for EGFRi-associated skin rash treatment
- Target market of 150,000 patients in the US, representing a $1 billion opportunity
- Phase 1/2 clinical trial planned to start by the end of 2024
- Clinical trials for ATR-04 have not yet begun
- Potential competition from existing off-label treatments
Insights
The FDA's Fast Track designation for ATR-04 is a significant milestone for Azitra. This designation recognizes the unmet medical need in treating EGFRi-associated skin rash, a common side effect of cancer treatments. The potential market size of
ATR-04's innovative approach using a live biotherapeutic product derived from Staphylococcus epidermidis is noteworthy. By engineering the strain for safety and controlled growth, Azitra addresses concerns typically associated with live bacterial therapies. The focus on treating IL-36γ elevation and S. aureus overgrowth targets the root causes of the skin condition.
The planned Phase 1/2 clinical trial by the end of 2024 will be important in determining ATR-04's efficacy and safety profile. If successful, it could potentially reduce treatment discontinuation rates for cancer patients on EGFR inhibitors, improving overall cancer treatment outcomes.
The Fast Track designation for ATR-04 is promising news for cancer patients undergoing EGFR inhibitor therapy. EGFRi-associated skin rash is a significant challenge in oncology, often leading to dose reductions or treatment discontinuation, which can compromise cancer treatment efficacy.
Current management options, including antibiotics and steroids, are suboptimal and can have their own side effects. ATR-04's targeted approach could potentially offer a more effective and safer alternative. By addressing the underlying mechanisms of skin toxicity, it may allow patients to maintain their cancer treatment regimens more consistently.
The potential improvement in quality of life for the estimated 150,000 affected patients in the US alone is substantial. If ATR-04 proves successful in clinical trials, it could become a standard of care in managing this common side effect, positively impacting cancer treatment adherence and outcomes.
Azitra's Fast Track designation for ATR-04 represents a potential catalyst for the company's stock. This designation could accelerate the development process, potentially bringing the product to market faster and reducing overall development costs.
The
Investors should note that while the Fast Track designation is positive, it doesn't guarantee approval. The upcoming Phase 1/2 trial results will be critical. Positive outcomes could drive further investor interest and potentially attract partnership opportunities with larger pharmaceutical companies. However, as with all clinical-stage biotech companies, risks remain high and investors should closely monitor trial progress and cash burn rate.
Francisco Salva, Azitra’s CEO, stated, "We are thrilled to announce the FDA has granted Fast Track designation to ATR-04, demonstrating that the FDA recognizes the unmet need for treatment of EGFRi-associated skin rash. Many cancer patients receive EGFR inhibitors, which often have significant side effects, resulting in rashes that require off-label treatment with antibiotics, steroids or other medications, or discontinuation of EGFRi therapy. The skin toxicity creates a high burden for these cancer patients, with a profound impact on their quality of life. We look forward to potentially accelerating the development of ATR-04 to treat this condition.”
The FDA's Fast Track program aims to facilitate the development, and expedite the review, of novel potential therapies that are designed to treat serious conditions and have the potential to address significant, unmet medical needs. This may include more frequent meetings with the FDA and eligibility for accelerated approval or rolling review.
ATR-04 is a live biotherapeutic product candidate containing an isolated, naturally derived Staphylococcus epidermidis strain that was engineered to be safer by deleting an antibiotic resistance gene and engineering auxotrophy to control the growth of ATR-04. ATR-04 is in development for EGFRi-associated skin rash, which is caused by the suppression of skin immunity and subsequent inflammation and often elevated levels of IL-36γ and S. aureus. Approximately 150,000 patients are affected by EGFRi-induced skin toxicity in
Azitra plans to initiate a multicenter, randomized, controlled Phase 1/2 clinical trial of ATR-04 in patients with dermal toxicity due to EGFR inhibitors by the end of 2024.
About Azitra, Inc.
Azitra, Inc. is an early-stage clinical biopharmaceutical company focused on developing innovative therapies for precision dermatology using engineered proteins and topical live biotherapeutic products. The Company has built a proprietary platform that includes a microbial library comprised of approximately 1,500 unique bacterial strains that can be screened for unique therapeutic characteristics. The platform is augmented by artificial intelligence and machine learning technology that analyzes, predicts and helps screen the Company's library of strains for drug like molecules. The Company's initial focus is on the development of genetically engineered strains of Staphylococcus epidermidis, or S. epidermidis, which the Company considers to be an optimal therapeutic candidate species for engineering of dermatologic therapies. For more information, please visit https://azitrainc.com/.
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 clinical development of our ATR-04 product candidate and the expected benefits of the FDA’s grant of Fast Track designation for ATR-04.
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 not realize the potential benefits of the FDA’s grant of Fast Track designation for ATR-04; we may fail to successfully complete our Phase 1/2 trial for ATR-04 and preclinical studies of other product candidates; we may not be able to obtain additional working capital with which to continue our current operations and clinical trials as and when needed; success in early phases of preclinical and clinical trials do not ensure later clinical trials will be successful; no drug product incorporating our engineered proteins or topical live biotherapeutic products has received FDA premarket approval or otherwise been incorporated into a commercial drug product; and those other risks disclosed or incorporated in the section “Risk Factors” included in our Form 10-Q filed with the SEC on August 12, 2024. Azitra explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240918592771/en/
Norman Staskey
Chief Financial Officer
staskey@azitra.com
Hayden IR
James Carbonara
(646)-755-7412
james@haydenir.com
Source: Azitra, Inc.
FAQ
What is the Fast Track Designation Azitra (AZTR) received for ATR-04?
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