Vaxart Announces Clinical Trial Initiation of Norovirus Oral Pill Vaccine Candidate
Vaxart (VXRT) has initiated a Phase 1 clinical trial for its second-generation oral norovirus vaccine delivered in pill form. The open-label, dose-ranging study will compare the new constructs head-to-head against first-generation versions, focusing on safety and immune parameters that correlated with protection in previous challenge studies.
The company expects topline data as early as mid-2025. Upon successful completion and securing partnership or funding, Vaxart plans to conduct a Phase 2 safety and immunogenicity study in the second half of 2025, followed by an FDA End of Phase 2 meeting. A potential Phase 3 trial could commence in 2026.
With no currently approved vaccines against norovirus, Vaxart aims to address this urgent public health need as the virus continues to spread globally.
Vaxart (VXRT) ha avviato uno studio clinico di Fase 1 per il suo vaccino contro il norovirus di seconda generazione, somministrato in forma di pillola. Lo studio a etichetta aperta, con variabilità di dosaggio, confronterà i nuovi costrutti direttamente con le versioni di prima generazione, concentrandosi sulla sicurezza e sui parametri immunitari che hanno mostrato correlazione con la protezione in studi precedenti.
L'azienda prevede di ottenere dati preliminari già a metà del 2025. Dopo il completamento con successo e l'ottenimento di partnership o finanziamenti, Vaxart intende condurre uno studio di Fase 2 sulla sicurezza e sull'immunogenicità nella seconda metà del 2025, seguito da un incontro con la FDA per la fine della Fase 2. Un potenziale studio di Fase 3 potrebbe iniziare nel 2026.
Con nessun vaccino attualmente approvato contro il norovirus, Vaxart mira a rispondere a questa urgente necessità di salute pubblica mentre il virus continua a diffondersi a livello globale.
Vaxart (VXRT) ha iniciado un ensayo clínico de Fase 1 para su vacuna oral de segunda generación contra el norovirus, administrada en forma de píldora. El estudio abierto, con variación de dosis, comparará los nuevos constructos directamente con las versiones de primera generación, centrándose en la seguridad y los parámetros inmunitarios que se correlacionaron con la protección en estudios de desafío anteriores.
La empresa espera obtener datos preliminares a mediados de 2025. Tras la finalización exitosa y la obtención de asociaciones o financiamiento, Vaxart planea llevar a cabo un estudio de Fase 2 sobre seguridad e inmunogenicidad en la segunda mitad de 2025, seguido de una reunión con la FDA al final de la Fase 2. Un posible ensayo de Fase 3 podría comenzar en 2026.
Sin vacunas aprobadas actualmente contra el norovirus, Vaxart busca abordar esta urgente necesidad de salud pública mientras el virus continúa propagándose a nivel mundial.
Vaxart (VXRT)는 알약 형태로 제공되는 2세대 구토바이러스 백신에 대한 1상 임상 시험을 시작했습니다. 개방형 라벨의 용량 범위 연구는 새로운 구성체를 1세대 버전과 직접 비교하며, 이전 도전 연구에서 보호와 상관관계가 있는 안전성 및 면역 매개변수에 중점을 둡니다.
회사는 2025년 중반에 초기 데이터가 나올 것으로 예상하고 있습니다. 성공적인 완료와 파트너십 또는 자금 확보 후, Vaxart는 2025년 하반기에 안전성 및 면역원성에 대한 2상 연구를 진행할 계획이며, 이후 FDA와의 2상 종료 회의가 있을 예정입니다. 2026년에는 잠재적인 3상 임상 시험이 시작될 수 있습니다.
현재 구토바이러스에 대한 승인된 백신이 없는 상황에서, Vaxart는 전 세계적으로 바이러스가 계속 확산되고 있는 가운데 이 긴급한 공공 건강 필요에 대응하고자 합니다.
Vaxart (VXRT) a lancé un essai clinique de phase 1 pour son vaccin oral de deuxième génération contre le norovirus, administré sous forme de pilule. L'étude ouverte, à dosage variable, comparera les nouvelles constructions directement aux versions de première génération, en se concentrant sur la sécurité et les paramètres immunitaires qui étaient corrélés à la protection dans les études de défi précédentes.
L'entreprise s'attend à des données préliminaires dès le milieu de 2025. Après une réalisation réussie et l'obtention de partenariats ou de financements, Vaxart prévoit de mener une étude de phase 2 sur la sécurité et l'immunogénicité dans la seconde moitié de 2025, suivie d'une réunion avec la FDA à la fin de la phase 2. Un essai de phase 3 pourrait commencer en 2026.
Avec aucun vaccin actuellement approuvé contre le norovirus, Vaxart vise à répondre à ce besoin urgent de santé publique alors que le virus continue de se propager à l'échelle mondiale.
Vaxart (VXRT) hat eine klinische Phase-1-Studie für seinen oralen Norovirus-Impfstoff der zweiten Generation in Form von Pillen gestartet. Die offene, dosisvariierende Studie wird die neuen Konstrukte direkt mit den Versionen der ersten Generation vergleichen und sich dabei auf Sicherheits- und Immunparameter konzentrieren, die in früheren Challenge-Studien mit Schutz korreliert haben.
Das Unternehmen erwartet erste Ergebnisse bereits Mitte 2025. Nach erfolgreichem Abschluss und Sicherstellung von Partnerschaften oder Finanzierungen plant Vaxart, in der zweiten Hälfte von 2025 eine Phase-2-Studie zur Sicherheit und Immunogenität durchzuführen, gefolgt von einem Treffen mit der FDA zum Ende der Phase 2. Eine mögliche Phase-3-Studie könnte 2026 beginnen.
Da derzeit keine Impfstoffe gegen Norovirus zugelassen sind, möchte Vaxart diesem dringenden Bedarf an öffentlicher Gesundheit nachkommen, während sich das Virus weiterhin weltweit ausbreitet.
- First-to-market opportunity with no currently approved norovirus vaccines
- Clear development timeline through potential Phase 3 in 2026
- Previous challenge study showed correlation with protection
- Phase 2 progression dependent on securing additional funding or partnership
- No guaranteed success from Phase 1 comparison trial
- Extended timeline to potential commercialization (post-2026)
- Topline data expected as early as mid-2025 -
SOUTH SAN FRANCISCO, Calif., March 11, 2025 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) today announced the initiation of a Phase 1, open label, dose ranging clinical trial evaluating its second-generation oral norovirus vaccine constructs head-to-head against its first-generation constructs.
“We are pleased to initiate a Phase 1 trial for our oral bivalent norovirus vaccine, delivered in a pill formulation, which will seek to demonstrate improved immune responses of our second-generation constructs,” said Steven Lo, Chief Executive Officer of Vaxart. “As norovirus continues to spread across the United States and globally, it has never been more important to address this urgent public health need. With no currently approved vaccines against norovirus, we are committed to advancing what we believe is the most promising norovirus vaccine candidate in clinical development and look forward to reviewing the topline data that is expected as early as mid-2025.”
The Phase 1 trial is an open label, dose ranging clinical study designed to evaluate Vaxart’s second-generation oral norovirus vaccine constructs head-to-head against its first-generation constructs. The study will measure safety and immune parameters that have correlated to protection in the completed norovirus challenge study.
If the Phase 1 trial is successful, and assuming a partnership or other funding, Vaxart expects to conduct a Phase 2 safety and immunogenicity study that could potentially begin as early as the second half of 2025, followed by an End of Phase 2 meeting with the U.S. Food and Drug Administration (FDA). A Phase 3 trial could then begin as early as 2026.
About Vaxart
Vaxart is a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform. Vaxart vaccines are designed to be administered using pills that can be stored and shipped without refrigeration and eliminate the risk of needle-stick injury. Vaxart believes that its proprietary pill vaccine delivery platform is suitable to deliver recombinant vaccines, positioning the company to develop oral versions of currently marketed vaccines and to design recombinant vaccines for new indications. Vaxart’s development programs currently include pill vaccines designed to protect against coronavirus, norovirus and influenza, as well as a therapeutic vaccine for human papillomavirus (HPV), Vaxart’s first immune-oncology indication. Vaxart has filed broad domestic and international patent applications covering its proprietary technology and creations for oral vaccination using adenovirus and TLR3 agonists.
Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Vaxart's strategy, prospects, plans and objectives, receipt of funding from BARDA, future cash runway and funding milestones, the results of the FDA’s review of any trials, studies, or data, results from preclinical and clinical trials and the timing of such results and such trials, commercialization agreements and licenses, and beliefs and expectations of management are forward-looking statements. These forward-looking statements may be accompanied by such words as “should,” “believe,” “could,” “potential,” “will,” “expected,” “anticipate,” “plan,” and other words and terms of similar meaning. Examples of such statements include, but are not limited to, statements relating to Vaxart’s ability to complete the Phase 1 trial of its oral bivalent norovirus vaccine; Vaxart's ability to develop and commercialize its product candidates, including its vaccine booster products; Vaxart's expectations regarding clinical results and trial data, including their design, and the timing of such trials and of receiving and reporting such clinical results and trial data; Vaxart’s expectations regarding timing of enrollment in studies; and Vaxart's expectations with respect to the effectiveness of its product candidates and the potential of its vaccine pill platform. Vaxart may not actually achieve the plans, carry out the intentions, or meet the expectations or projections disclosed in the forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations, and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Vaxart makes, including uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement, and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates, and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; decisions by regulatory authorities impacting labeling, manufacturing processes, and safety that could affect the availability or commercial potential of any product candidate, including the possibility that Vaxart's product candidates may not be approved by the FDA or non-U.S. regulatory authorities; that, even if approved by the FDA or non-U.S. regulatory authorities, Vaxart's product candidates may not achieve broad market acceptance; that a Vaxart collaborator may not attain development and commercial milestones; that Vaxart or its partners may experience manufacturing issues and delays due to events within, or outside of, Vaxart's or its partners' control; difficulties in production, particularly in scaling up initial production, including difficulties with production costs and yields, quality control, including stability of the product candidate and quality assurance testing, shortages of qualified personnel or key raw materials, and compliance with strictly enforced federal, state, and foreign regulations; that Vaxart may not be able to obtain, maintain, and enforce necessary patent and other intellectual property protection; that Vaxart's capital resources may be inadequate; Vaxart's ability to resolve pending legal matters; Vaxart's ability to obtain sufficient capital to fund its operations on terms acceptable to Vaxart, if at all; the impact of government healthcare proposals and policies; competitive factors; and other risks described in the "Risk Factors" sections of Vaxart's Quarterly and Annual Reports filed with the U.S. Securities and Exchange Commission. Vaxart does not assume any obligation to update any forward-looking statements, except as required by law.
Contact
Vaxart Media and Investor Relations
Matt Steinberg
FINN Partners
IR@vaxart.com
(646) 871-8481
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