Azitra, Inc. Announces Late-Breaking Presentation at the European Academy of Dermatology and Venereology Congress
Azitra, Inc. (NYSE American: AZTR) announced a late-breaking presentation at the European Academy of Dermatology and Venereology (EADV) Congress 2024 in Amsterdam. Dr. Mary Spellman will present on September 26, 2024, discussing the development of ATR-04, a live biotherapeutic product for treating epidermal growth factor receptor (EGFR) inhibitor-induced dermal toxicity.
ATR-04 is an engineered Staphylococcus epidermidis strain designed to be safer by deleting an antibiotic resistance gene and controlling growth through auxotrophy. It targets EGFRi-associated skin toxicity, which affects approximately 150,000 patients in the United States. Azitra has an active IND for a Phase 1/2 clinical trial of ATR-04, which has received Fast Track designation from the FDA.
The presentation will cover ATR-04's preclinical development and details of the planned clinical trial. It will be available on Azitra's website after the event.
Azitra, Inc. (NYSE American: AZTR) ha annunciato una presentazione dell'ultimo minuto al Congresso della European Academy of Dermatology and Venereology (EADV) 2024 ad Amsterdam. La Dr.ssa Mary Spellman presenterà il 26 settembre 2024, discutendo dello sviluppo di ATR-04, un prodotto bioterapeutico vivo per il trattamento della tossicità dermica indotta dagli inibitori del recettore del fattore di crescita epidermico (EGFR).
ATR-04 è un
Azitra, Inc. (NYSE American: AZTR) anunció una presentación de última hora en el Congreso de la Academia Europea de Dermatología y Venereología (EADV) 2024 en Ámsterdam. La Dra. Mary Spellman presentará el 26 de septiembre de 2024, discutiendo el desarrollo de ATR-04, un producto bioterapéutico vivo para el tratamiento de la toxicidad dérmica inducida por inhibidores del receptor del factor de crecimiento epidérmico (EGFR). ATR-04 es una cepa de Staphylococcus epidermidis diseñada para ser más segura al eliminar un gen de resistencia a los antibióticos y controlar el crecimiento a través de la auxotrofia. Está dirigida a la toxicidad cutánea asociada a EGFRi, que afecta a aproximadamente 150,000 pacientes en los Estados Unidos. Azitra tiene un IND activo para un ensayo clínico de fase 1/2 de ATR-04, que ha recibido la designación de Vía Rápida por parte de la FDA. La presentación abordará el desarrollo preclínico de ATR-04 y los detalles del ensayo clínico planificado. Estará disponible en el sitio web de Azitra después del evento. Azitra, Inc. (NYSE American: AZTR)는 2024년 암스테르담에서 열리는 유럽 피부과 및 성병학회(EADV)에서 늦게 진행되는 발표를 발표했습니다. 메리 스펠먼 박사는 2024년 9월 26일에 발표를 하며, 표피 성장 인자 수용체(EGFR) 억제제에 의해 유발된 피부 독성을 치료하기 위한 생물 치료 제품 ATR-04의 개발에 대해 논의할 예정입니다. ATR-04는 항생제 내성 유전자를 삭제하고 보조 영양을 통해 성장을 조절하여 보다 안전하도록 설계된 황색포도상구균 epidermidis 균주입니다. EGFRi와 관련된 피부 독성을 목표로 하며, 이는 미국의 약 150,000명의 환자에게 영향을 미칩니다. Azitra는 ATR-04에 대한 임상 1/2상 시험을 위한 활성 IND를 보유하고 있으며, 이는 FDA로부터 신속 심사 지정을 받았습니다. 이 발표에서는 ATR-04의 전임상 개발 및 계획된 임상 시험의 세부 사항을 다룰 것입니다. 행사가 끝난 후 Azitra의 웹사이트에서 확인할 수 있습니다. Azitra, Inc. (NYSE American: AZTR) a annoncé une présentation de dernière minute lors du Congrès de l'Académie européenne de dermatologie et de vénéréologie (EADV) 2024 à Amsterdam. Le Dr Mary Spellman présentera le 26 septembre 2024, discutant du développement d'ATR-04, un produit biothérapeutique vivant pour traiter la toxicité dermique induite par les inhibiteurs du récepteur du facteur de croissance épidermique (EGFR). ATR-04 est une souche de Staphylococcus epidermidis conçue pour être plus sûre en supprimant un gène de résistance aux antibiotiques et en contrôlant la croissance par auxotrophie. Il cible la toxicité cutanée associée aux inhibiteurs d'EGFR, qui touche environ 150 000 patients aux États-Unis. Azitra a un IND actif pour un essai clinique de phase 1/2 d'ATR-04, qui a reçu la désignation Fast Track de la FDA. La présentation couvrira le développement préclinique d'ATR-04 et les détails de l'essai clinique prévu. Elle sera disponible sur le site web d'Azitra après l'événement. Azitra, Inc. (NYSE American: AZTR) gab eine kurzfristige Präsentation auf dem Kongress der Europäischen Akademie für Dermatologie und Venerologie (EADV) 2024 in Amsterdam bekannt. Dr. Mary Spellman wird am 26. September 2024 präsentieren und über die Entwicklung von ATR-04 sprechen, einem lebensfähigen biotherapeutischen Produkt zur Behandlung von durch EGFR-Inhibitoren induzierter Hauttoxizität. ATR-04 ist ein Staphylococcus epidermidis-Stamm, der sicherer gestaltet wurde, indem ein Antibiotika-Resistenzgen entfernt wurde und das Wachstum durch Auxotrophie kontrolliert wird. Es zielt auf die EGFRi-assoziierte Hauttoxizität ab, die etwa 150.000 Patienten in den Vereinigten Staaten betrifft. Azitra hat einen aktiven IND für eine Phase 1/2 klinische Studie von ATR-04, die von der FDA die Fast-Track-Position erhalten hat. Die Präsentation wird die präklinische Entwicklung von ATR-04 und die Einzelheiten der geplanten klinischen Studie umfassen. Sie wird nach der Veranstaltung auf der Website von Azitra verfügbar sein.
- ATR-04 received Fast Track designation from the FDA
- Active IND for Phase 1/2 clinical trial of ATR-04
- Potential market of 150,000 patients in the US for EGFRi-induced skin toxicity
- Presentation at a major dermatology congress (EADV)
- None.
ATR-04 is a live biotherapeutic product candidate consisting of an S. epidermidis strain that was isolated from a healthy volunteer and 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 toxicity, which is caused by the suppression of skin immunity by EGFRis and subsequent inflammation and often elevated levels of IL-36γ and S. aureus. There are approximately 150,000 patients suffering from EGFRi-induced skin toxicity in
The data in the oral presentation will showcase the preclinical development of ATR-04 and details around the planned Phase 1/2 clinical trial in patients with dermal toxicity due to EGFR inhibitors.
The presentation will be available on Azitra’s website at https://ir.azitrainc.com/news-events/presentations.
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 expected timing of the presentation of data from the Phase 1b study of ATR-12, the filing of an IND application, and the presentation of data from our Phase 1b for ATR-04, the IND filing for ATR-01, the timing of having a signed license agreement with Bayer, and statements about our clinical and pre-clinical programs, and corporate and clinical/pre-clinical 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 fail to successfully complete our Phase 1/2 trial for ATR-04 and preclinical studies of other product candidates and obtain required approval before commercialization; 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 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/20240924222938/en/
Norman Staskey
Chief Financial Officer
staskey@azitrainc.com
Source: Azitra, Inc.
FAQ
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