Azitra Announces First Patient Dosed in Phase 1b Trial of ATR-12 for Netherton Syndrome
Azitra (NYSE American: AZTR) has initiated dosing in its Phase 1b clinical trial of ATR-12 for Netherton syndrome, a chronic genetic skin disease. The study will enroll about 12 adult patients with twice-daily treatment for 14 days, focusing on safety and tolerability as primary endpoints. Secondary endpoints include efficacy signals and biomarkers. Azitra expects to report interim safety data in early 2025 and full results in the second half of 2025.
ATR-12 is a proprietary strain of Staphylococcus epidermidis engineered to express therapeutic levels of an active LEKTI protein subunit. The multicenter, randomized, double-blind, vehicle-controlled study (NCT06137157) will treat patients with 109 CFU / g of ATR-12 or its vehicle control twice daily on contralateral body sides.
Azitra (NYSE American: AZTR) ha iniziato la somministrazione nel suo studio clinico di fase 1b su ATR-12 per la sindrome di Netherton, una malattia genetica cronica della pelle. Lo studio arruolerà circa 12 pazienti adulti con un trattamento due volte al giorno per 14 giorni, ponendo l'accento sulla sicurezza e la tollerabilità come obiettivi primari. Gli obiettivi secondari includono segnali di efficacia e biomarcatori. Azitra prevede di riportare dati intermedi sulla sicurezza all'inizio del 2025 e risultati completi nella seconda metà del 2025.
ATR-12 è un ceppo proprietario di Staphylococcus epidermidis concepito per esprimere livelli terapeutici di una subunità proteica attiva LEKTI. Lo studio multicentrico, randomizzato, in doppio cieco e controllato con veicolo (NCT06137157) tratterà i pazienti con 109 CFU/g di ATR-12 o il suo controllo veicolare due volte al giorno sui lati corporei contro-laterali.
Azitra (NYSE American: AZTR) ha iniciado la dosificación en su ensayo clínico de fase 1b de ATR-12 para el sindrome de Netherton, una enfermedad crónica genética de la piel. El estudio inscribirá a aproximadamente 12 pacientes adultos con tratamiento dos veces al día durante 14 días, centrándose en la seguridad y tolerabilidad como objetivos primarios. Los objetivos secundarios incluyen señales de eficacia y biomarcadores. Azitra espera informar sobre datos intermedios de seguridad a principios de 2025 y resultados completos en la segunda mitad de 2025.
ATR-12 es una cepa patentada de Staphylococcus epidermidis diseñada para expresar niveles terapéuticos de una subunidad proteica LEKTI activa. El estudio multicéntrico, aleatorizado, doble ciego y controlado con vehículo (NCT06137157) tratará a los pacientes con 109 CFU/g de ATR-12 o su control vehicular dos veces al día en lados corporales contralaterales.
Azitra (NYSE American: AZTR)는 ATR-12의 네더튼 증후군에 대한 1b 단계 임상 시험에서 투약을 시작했다. 이 연구는 12명의 성인 환자를 모집하며, 하루 두 번의 치료를 14일 동안 진행하고, 안전성과 내약성을 주요 목표로 합니다. 2차 목표에는 효능 신호와 바이오마커가 포함됩니다. Azitra는 2025년 초에 중간 안전성 데이터를 보고하고, 2025년 하반기에 전체 결과를 발표할 것으로 기대하고 있습니다.
ATR-12는 치료 수준의 LEKTI 단백질 하위 단위를 발현하도록 설계된 독점적인 Staphylococcus epidermidis 균주입니다. 다기관, 무작위, 이중 맹검, 차량 대조 연구(NCT06137157)는 환자에게 ATR-12 또는 그 차량 대조군을 하루 두 번, 대칭 체부의 반대측에서 치료할 것입니다.
Azitra (NYSE American: AZTR) a initié le dosage dans son essai clinique de phase 1b sur ATR-12 pour le syndrome de Netherton, une maladie génétique chronique de la peau. L'étude recrutera environ 12 patients adultes avec un traitement deux fois par jour pendant 14 jours, en se concentrant sur la sécurité et la tolérance comme principaux objectifs. Les objectifs secondaires incluent des signaux d'efficacité et des biomarqueurs. Azitra prévoit de communiquer les données de sécurité intermédiaires au début de 2025 et les résultats complets dans la seconde moitié de 2025.
ATR-12 est une souche propriétaire de Staphylococcus epidermidis conçue pour exprimer des niveaux thérapeutiques d'une sous-unité protéique LEKTI active. L'étude multicentrique, randomisée, en double aveugle et contrôlée par un véhicule (NCT06137157) traitera les patients avec 109 CFU/g d'ATR-12 ou son contrôle véhicule deux fois par jour sur des côtés corporels contralatéraux.
Azitra (NYSE American: AZTR) hat die Dosierung eingeleitet in seiner klinischen Studie der Phase 1b zu ATR-12 für Netherton-Syndrom, einer chronischen genetischen Hauterkrankung. Die Studie wird etwa 12 erwachsene Patienten mit einer zweimal täglichen Behandlung über 14 Tage rekrutieren, wobei Sicherheit und Verträglichkeit die primären Endpunkte darstellen. Sekundäre Endpunkte umfassen Wirksamkeitssignale und Biomarker. Azitra erwartet, anfängliche Sicherheitsdaten Anfang 2025 zu berichten und vollständige Ergebnisse in der zweiten Hälfte des Jahres 2025 vorzulegen.
ATR-12 ist ein proprietärer Stamm von Staphylococcus epidermidis, der so konzipiert ist, dass er therapeutische Mengen einer aktiven LEKTI-Protein-Untereinheit exprimiert. Die multizentrische, randomisierte, doppelblinde, placebokontrollierte Studie (NCT06137157) wird Patienten mit 109 CFU/g von ATR-12 oder dem entsprechenden Pflanzenschutzmittel kontrollieren, zweimal täglich auf gegenüberliegenden Körperseiten behandeln.
- Initiation of Phase 1b clinical trial for ATR-12 in Netherton syndrome
- Potential to address an unmet medical need for a life-threatening skin condition
- Engineered bacterial strain (ATR-12) designed to express therapeutic protein levels
- Well-defined clinical trial design with safety, efficacy, and biomarker endpoints
- Results not expected until 2025, indicating a long wait for potential revenue generation
- Small patient population (12 adults) may limit initial data significance
- Short treatment duration (14 days) may not fully demonstrate long-term efficacy or safety
The initiation of the Phase 1b trial for ATR-12 in Netherton syndrome is a significant milestone for Azitra. This study, involving 12 adult patients, aims to evaluate the safety and efficacy of ATR-12, a novel biotherapeutic approach using engineered Staphylococcus epidermidis. The trial's design, including the 14-day treatment period and contralateral application, is well-structured to assess both safety and potential efficacy signals.
Key points to consider:
- The primary focus on safety is important for this first-in-human study
- Secondary endpoints may provide early insights into efficacy
- The inclusion of biomarker analysis could offer valuable mechanistic information
While the 2025 timeline for results may seem distant, it's typical for such trials. Investors should monitor for any interim safety data in early 2025, which could influence the company's trajectory.
Azitra's ATR-12 represents an innovative approach to treating Netherton syndrome, a rare genetic disorder with treatment options. The use of engineered bacteria to deliver therapeutic proteins directly to the skin is a cutting-edge strategy in the field of dermatology.
Key considerations:
- The proprietary strain of S. epidermidis could provide a competitive advantage
- Success in this trial could pave the way for applications in other skin disorders
- The focus on LEKTI protein delivery addresses the root cause of Netherton syndrome
However, investors should be aware of potential challenges, including regulatory hurdles for live biotherapeutics and the need for long-term safety data. The success of ATR-12 could position Azitra as a leader in precision dermatology, but it's a long road ahead with many milestones to achieve.
ATR-12 is Azitra's lead candidate, a proprietary strain of Staphylococcus epidermidis engineered to express therapeutic levels of an active subunit of the LEKTI protein to treat Netherton syndrome, a chronic genetic skin disease that can be life threatening.
"Dosing the first patient in our Phase 1b trial of ATR-12 marks a vital milestone for Azitra and for patients suffering from Netherton syndrome," said Francisco Salva, CEO of Azitra. "We are exhilarated to start dosing patients and look forward to executing this trial and delivering clinical data."
Mary Spellman, MD, Azitra’s acting CMO, added, “We are thrilled to begin this clinical trial of ATR-12 in patients with Netherton syndrome. These patients often suffer from poor quality of life due to debilitating disease. This first-in-human study will inform future studies for the treatment of Netherton syndrome, including in pediatric patients and for longer treatment durations.”
The Phase 1b trial (NCT06137157) is a multicenter, randomized, double-blind, vehicle-controlled study in approximately 12 adult patients with Netherton syndrome. Patients will be treated with 109 CFU / g twice daily with ATR-12 or its vehicle control on the contralateral side of the body twice daily for 14 days. The primary objective is to assess the safety and tolerability of topical ATR-12 application. Secondary objectives include evaluating efficacy signals (e.g., investigator and patient global assessments) and skin pharmacokinetics of the LEKTI subunit. Additional exploratory objectives include evaluating pharmacodynamic parameters, biomarkers, anti-LEKTI response, and cytokine responses.
About ATR-12
ATR-12 (also known as ATR12-351) is an engineered strain of S. epidermidis that expresses an active subunit of human lympho-epithelial Kazal-type-related inhibitor (LEKTI) protein, which is missing in patients with Netherton syndrome, a chronic and sometimes fatal disease of the skin estimated to affect approximately one to nine in every 100,000. ATR-12 has been engineered to deliver the missing LEKTI protein when applied topically. Azitra has initiated a 12-patient, Phase 1b clinical trial, which will assess safety, tolerability, and efficacy endpoints (NCT06137157). Azitra expects to announce initial safety data in early 2025.
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 and statements about 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 fail to successfully complete our Phase 1b trial for ATR-12 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 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.
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Investor Relations Contact:
Norman Staskey
Chief Financial Officer
staskey@azitrainc.com
Hayden IR
James Carbonara
(646) 755-7412
james@haydenir.com
Source: Azitra, Inc.
FAQ
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