Vaxart Completes Enrollment in Phase 1 Trial for its Norovirus Oral Pill Vaccine Candidate
Vaxart has completed enrollment in its Phase 1 clinical trial comparing second-generation and first-generation oral norovirus vaccine constructs. The company expects to release topline data in mid-2025.
The open-label, dose-ranging study will evaluate safety and immune parameters that previously correlated with protection in a completed norovirus challenge study. A Data and Safety Monitoring Board has reviewed interim safety data and recommended continuing the study without modifications.
CEO Steven Lo emphasized the significant unmet need for a norovirus vaccine, expressing optimism about the potential increased potency of their second-generation constructs. Pending successful Phase 1 results and securing partnership or funding, Vaxart plans to:
- Launch Phase 2 safety and immunogenicity study in late 2025
- Hold End of Phase 2 meeting with FDA
- Potentially begin Phase 3 trials in 2026
Vaxart ha completato il reclutamento per il suo studio clinico di Fase 1 che confronta i costrutti del vaccino orale di seconda generazione con quelli di prima generazione contro il norovirus. L'azienda prevede di pubblicare i dati principali a metà del 2025.
Lo studio in aperto, a dosi variabili, valuterà la sicurezza e i parametri immunitari precedentemente correlati alla protezione in uno studio di sfida con norovirus già completato. Un Comitato di Monitoraggio dei Dati e della Sicurezza ha esaminato i dati preliminari di sicurezza e ha raccomandato di proseguire lo studio senza modifiche.
Il CEO Steven Lo ha sottolineato il forte bisogno insoddisfatto di un vaccino contro il norovirus, manifestando ottimismo riguardo alla potenziale maggiore efficacia dei loro costrutti di seconda generazione. In caso di risultati positivi della Fase 1 e di acquisizione di partnership o finanziamenti, Vaxart intende:
- Avviare uno studio di Fase 2 sulla sicurezza e immunogenicità entro la fine del 2025
- Tenere una riunione di fine Fase 2 con la FDA
- Avviare eventualmente le sperimentazioni di Fase 3 nel 2026
Vaxart ha completado la inscripción en su ensayo clínico de Fase 1 que compara las construcciones de vacunas orales de segunda generación con las de primera generación contra el norovirus. La compañía espera publicar los datos principales a mediados de 2025.
El estudio abierto y con dosis variables evaluará la seguridad y los parámetros inmunológicos que previamente se correlacionaron con la protección en un estudio de desafío con norovirus ya concluido. Un Comité de Monitoreo de Datos y Seguridad ha revisado los datos de seguridad interinos y recomendó continuar el estudio sin modificaciones.
El CEO Steven Lo destacó la gran necesidad insatisfecha de una vacuna contra el norovirus, mostrando optimismo sobre el posible aumento de potencia de sus construcciones de segunda generación. Pendientes de resultados exitosos en la Fase 1 y de asegurar asociaciones o financiación, Vaxart planea:
- Lanzar un estudio de seguridad e inmunogenicidad de Fase 2 a finales de 2025
- Realizar una reunión de fin de Fase 2 con la FDA
- Posiblemente iniciar ensayos de Fase 3 en 2026
Vaxart는 2세대와 1세대 경구용 노로바이러스 백신 후보물질을 비교하는 1상 임상시험 등록을 완료했습니다. 회사는 2025년 중반에 주요 결과를 발표할 예정입니다.
이 공개 라벨, 용량 범위 연구는 이전에 노로바이러스 도전 연구에서 보호와 연관된 안전성과 면역 지표를 평가할 것입니다. 데이터 및 안전성 모니터링 위원회는 중간 안전성 데이터를 검토하고 수정 없이 연구를 계속할 것을 권고했습니다.
CEO 스티븐 로는 노로바이러스 백신에 대한 큰 미충족 수요를 강조하며 2세대 후보물질의 잠재적 향상된 효능에 대해 낙관적인 입장을 밝혔습니다. 1상 결과가 성공적이고 파트너십 또는 자금 확보가 이루어지면 Vaxart는 다음을 계획하고 있습니다:
- 2025년 말에 2상 안전성 및 면역원성 연구 시작
- FDA와 2상 종료 미팅 개최
- 2026년에 3상 시험 시작 가능성
Vaxart a terminé le recrutement de son essai clinique de phase 1 comparant les constructions de vaccins oraux de deuxième génération à celles de première génération contre le norovirus. La société prévoit de publier les données principales à la mi-2025.
Cette étude ouverte avec différentes doses évaluera la sécurité et les paramètres immunitaires qui avaient précédemment été corrélés à la protection dans une étude de challenge norovirus achevée. Un comité de surveillance des données et de la sécurité a examiné les données de sécurité intermédiaires et recommandé de poursuivre l'étude sans modifications.
Le PDG Steven Lo a souligné le besoin important non satisfait d'un vaccin contre le norovirus, exprimant son optimisme quant à la puissance potentiellement accrue de leurs constructions de deuxième génération. Sous réserve de résultats positifs en phase 1 et de l'obtention de partenariats ou de financements, Vaxart prévoit de :
- Lancer une étude de phase 2 sur la sécurité et l'immunogénicité fin 2025
- Organiser une réunion de fin de phase 2 avec la FDA
- Éventuellement débuter les essais de phase 3 en 2026
Vaxart hat die Einschreibung für seine Phase-1-Studie abgeschlossen, in der orale Norovirus-Impfstoffkandidaten der zweiten Generation mit denen der ersten Generation verglichen werden. Das Unternehmen erwartet, die wichtigsten Daten Mitte 2025 zu veröffentlichen.
Die offene, dosisgestufte Studie wird Sicherheit und Immunparameter bewerten, die zuvor mit Schutz in einer abgeschlossenen Norovirus-Herausforderungsstudie korrelierten. Ein Daten- und Sicherheitsüberwachungsausschuss hat Zwischen-Sicherheitsdaten überprüft und empfohlen, die Studie ohne Änderungen fortzusetzen.
CEO Steven Lo betonte den erheblichen ungedeckten Bedarf an einem Norovirus-Impfstoff und zeigte sich optimistisch hinsichtlich der potenziell höheren Wirksamkeit ihrer Konstrukte der zweiten Generation. Bei erfolgreichen Phase-1-Ergebnissen und dem Sichern von Partnerschaften oder Finanzierung plant Vaxart:
- Start einer Phase-2-Studie zur Sicherheit und Immunogenität Ende 2025
- Abhalten eines End-of-Phase-2-Meetings mit der FDA
- Möglichen Beginn von Phase-3-Studien im Jahr 2026
- Completed enrollment in Phase 1 trial for norovirus vaccine candidate
- DSMB safety review recommended study continuation without modifications
- Clear development pathway with potential Phase 2 start in H2 2025
- Second-generation vaccine constructs potentially more potent than first-generation
- Phase 2 progression dependent on securing partnership or additional funding
- No efficacy data available yet from Phase 1 trial
- Results not expected until mid-2025, indicating several months of waiting period
Insights
Vaxart completes Phase 1 enrollment for oral norovirus vaccine - a routine milestone with results expected mid-2025, amid funding uncertainty for later stages.
Vaxart's announcement of completed enrollment in its Phase 1 trial represents a procedural milestone in its norovirus vaccine development program. The trial's head-to-head design comparing second-generation oral vaccine constructs against first-generation versions should yield valuable comparative data when results emerge in mid-2025.
The positive interim safety review from the Data and Safety Monitoring Board provides reassurance but represents a standard early development hurdle. The company has outlined a conditional development pathway with Phase 2 potentially beginning in H2 2025 and Phase 3 in 2026, explicitly contingent on "a partnership or other funding" - language that signals financial constraints that could impact development timelines.
While norovirus represents a legitimate unmet medical need as a leading cause of acute gastroenteritis worldwide, the extended timeline places any potential commercial impact years into the future. This enrollment completion keeps the program on track but doesn't fundamentally alter the investment thesis or timeline to potential commercialization.
- Topline data expected in mid-2025 -
SOUTH SAN FRANCISCO, Calif., April 30, 2025 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) today announced that it completed enrollment of its Phase 1 clinical trial evaluating its second-generation oral norovirus vaccine constructs head-to-head against its first-generation constructs.
“Completing enrollment in this trial bring us one step closer in our development of a norovirus vaccine, where there is a significant unmet need,” said Steven Lo, Chief Executive Officer of Vaxart. "We are excited about the potential of our second-generation oral norovirus vaccine constructs that we believe may be more potent than our first-generation constructs. We look forward to sharing the topline data in 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. Norovirus is a leading cause of acute gastroenteritis worldwide, and Vaxart's oral vaccine candidate aims to provide a convenient and effective solution for this significant public health challenge.
An independent Data and Safety Monitoring Board (DSMB) conducted a pre-planned interim safety data review and recommended the study to continue without any modifications.
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, funding milestones, the results of the FDA’s review of any trials, studies, or data, results from 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
This press release was published by a CLEAR® Verified individual.
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