BioVie to Present Design of Planned Phase 2 Study of Bezisterim for the Treatment of Long COVID at the Demystifying Long COVID International Conference
BioVie (NASDAQ: BIVI) announced the acceptance of an abstract detailing their planned Phase 2 trial of bezisterim for Long COVID treatment at the Demystifying Long COVID International Conference in Barcelona. The study, fully funded by the U.S. Department of Defense, will be a double-blind, randomized, placebo-controlled trial involving approximately 200 patients. The trial aims to evaluate the safety, tolerability, and potential efficacy of bezisterim over a 3-month treatment period, focusing on reducing neurocognitive symptoms associated with Long COVID. The presentation will be delivered on November 21, 2024.
BioVie (NASDAQ: BIVI) ha annunciato l'accettazione di un abstract che dettaglia il loro previsto studio di Fase 2 con bezisterim per il trattamento del Long COVID durante la Demystifying Long COVID International Conference a Barcellona. Lo studio, finanziato interamente dal Dipartimento della Difesa degli Stati Uniti, sarà uno studio randomizzato, in doppio ciego e controllato con placebo che coinvolgerà circa 200 pazienti. L'obiettivo dello studio è valutare la sicurezza, la tollerabilità e la potenziale efficacia del bezisterim nel corso di un periodo di trattamento di 3 mesi, concentrandosi sulla riduzione dei sintomi neurocognitivi associati al Long COVID. La presentazione avrà luogo il 21 novembre 2024.
BioVie (NASDAQ: BIVI) anunció la aceptación de un resumen que detalla su prevista prueba de Fase 2 de bezisterim para el tratamiento del Long COVID en la Conferencia Internacional Demystifying Long COVID en Barcelona. El estudio, totalmente financiado por el Departamento de Defensa de los Estados Unidos, será un ensayo doble ciego, aleatorizado y controlado con placebo que involucrará aproximadamente a 200 pacientes. La prueba tiene como objetivo evaluar la seguridad, la tolerabilidad y la posible eficacia de bezisterim durante un período de tratamiento de 3 meses, centrándose en la reducción de los síntomas neurocognitivos asociados con el Long COVID. La presentación se llevará a cabo el 21 de noviembre de 2024.
BioVie (NASDAQ: BIVI)는 바르셀로나에서 열리는 Demystifying Long COVID 국제 회의에서 Long COVID 치료를 위한 bezisterim의 2상 시험 계획에 대한 초록이 수락되었음을 발표했습니다. 이 연구는 미국 국방부의 전액 지원을 받으며, 약 200명의 환자가 참여하는 이중 맹검, 무작위, 위약 대조 시험이 될 것입니다. 이번 시험은 Long COVID와 관련된 신경인지 증상의 감소에 중점을 두고 3개월 치료 기간 동안 bezisterim의 안전성, 내약성 및 잠재적 효능을 평가하는 것을 목표로 하고 있습니다. 발표는 2024년 11월 21일에 이루어질 예정입니다.
BioVie (NASDAQ: BIVI) a annoncé l'acceptation d'un résumé détaillant leur projet de phase 2 concernant le bezisterim pour le traitement du Long COVID lors de la Conférence Internationale Demystifying Long COVID à Barcelone. L'étude, entièrement financée par le Département de la Défense des États-Unis, sera un essai randomisé, en double aveugle et contrôlé par placebo impliquant environ 200 patients. L'essai vise à évaluer la sécurité, la tolérance et l'efficacité potentielle du bezisterim sur une période de traitement de 3 mois, en mettant l'accent sur la réduction des symptômes neurocognitifs associés au Long COVID. La présentation aura lieu le 21 novembre 2024.
BioVie (NASDAQ: BIVI) gab bekannt, dass ein Abstract akzeptiert wurde, der ihre geplante Phase-2-Studie zu bezisterim zur Behandlung von Long COVID auf der Demystifying Long COVID International Conference in Barcelona beschreibt. Die Studie, vollständig finanziert vom US-Verteidigungsministerium, wird eine doppelt-blinde, randomisierte, placebokontrollierte Studie sein, an der etwa 200 Patienten beteiligt sind. Ziel der Studie ist es, die Sicherheit, Verträglichkeit und potenzielle Wirksamkeit von bezisterim über einen 3-monatigen Behandlungszeitraum hinweg zu bewerten, wobei der Fokus auf der Verringerung der neurokognitiven Symptome liegt, die mit Long COVID verbunden sind. Die Präsentation wird am 21. November 2024 stattfinden.
- Secured full funding from U.S. Department of Defense for Phase 2 trial
- Large-scale study with 200 patients planned
- None.
Insights
This presentation of a planned Phase 2 study design, while scientifically interesting, does not constitute market-moving news. The abstract acceptance and upcoming conference presentation are routine events in drug development. While the study is funded by a DOD grant, no new financial details or preliminary results are being disclosed. The presentation will only outline the methodology for a future trial, making this a forward-looking event without immediate impact on company valuation or investor decision-making.
CARSON CITY, Nev., Nov. 20, 2024 (GLOBE NEWSWIRE) -- BioVie Inc. (NASDAQ: BIVI), (“BioVie” or the “Company”), a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease, today announced that an abstract on the design of its planned Phase 2 trial evaluating bezisterim in Long COVID has been accepted as a poster presentation at the Demystifying Long COVID International Conference, November 21st & 22nd 2024, in Barcelona Spain.
The planned Phase 2 study, which is fully funded by a grant from the U.S. Department of Defense (DOD), is a double-blind, randomized (1:1), placebo-controlled, multicenter trial in approximately 200 patients to evaluate the safety, tolerability and potential efficacy of 3 months of treatment with bezisterim to reduce the neurocognitive symptoms associated with Long COVID.
Details for the presentation are as follows:
Title: A Double-Blind, Randomized Study to Evaluate the Efficacy and Safety of Bezisterim (NE3107) in Adults with Long COVID
Poster number: 28
Presentation date: November 21, 2024
Presenter: Penelope Markham, Ph.D, Senior Vice President and Program Lead, Long COVID, BioVie Inc.
About Long COVID
Long COVID is a condition in which symptoms of COVID-19, the acute respiratory disease caused by the SARS-CoV-2 virus, persist for an extended period of time, generally three months or more. Common symptoms include lingering loss of smell and taste, extreme fatigue, and “brain fog,” though persistent cardiovascular and respiratory problems, muscle weakness, and neurologic issues have also been documented. The Centers for Disease Control recently reported that
Terms of the Department of Defense Award
The work is supported by the Assistant Secretary of Defense for Health Affairs endorsed by the Department of Defense, by a fully funded award in the amount of
About BioVie Inc.
BioVie Inc. (NASDAQ: BIVI) is a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders (Long COVID, Alzheimer's disease and Parkinson’s disease) and advanced liver disease. In neurodegenerative disease, the Company’s drug candidate bezisterim inhibits inflammatory activation of extracellular signal-regulated kinase and the transcription factor nuclear factor-kB, and the associated neuroinflammation and insulin resistance but not ERK and NFkB homeostatic functions (e.g., insulin signaling and neuron growth and survival). Both neuroinflammation and insulin resistance are drivers of AD and PD. Persistent systematic inflammation and neuroinflammation are key features in patients with neurological symptoms of Long COVID. In liver disease, the Company’s Orphan drug candidate BIV201 (continuous infusion terlipressin), with FDA Fast Track status, is being evaluated and discussed with guidance received from the FDA regarding the design of Phase 3 clinical testing of BIV201 for the reduction of further decompensation in participants with liver cirrhosis and ascites. The active agent is approved in the U.S. and in about 40 countries for related complications of advanced liver cirrhosis. For more information, visit www.bioviepharma.com.
References
1Ford ND, Agedew A, Dalton AF, Singleton J, Perrine CG, Saydah S. Notes from the Field: Long COVID Prevalence Among Adults — United States, 2022. MMWR Morb Mortal Wkly Rep 2024;73:135–136. DOI: http://dx.doi.org/10.15585/mmwr.mm7306a4.
2 Azhir A et al. “Precision Phenotyping for Curating Research Cohorts of Patients with Unexplained Post-Acute Sequelae of COVID-19” Med DOI: 10.1016/j.medj.2024.10.009, in press
3Cutler, David M. 2022 The economic costs of Long COVID: An update. long_covid_update_7-22.pdf (harvard.edu)
Forward-Looking Statements
This press release contains forward-looking statements, which may be identified by words such as "expect," "look forward to," "anticipate" "intend," "plan," "believe," "seek," "estimate," "will," "project" or words of similar meaning. Although BioVie Inc. believes such forward-looking statements are based on reasonable assumptions, it can give no assurance that its expectations will be attained. Actual results may vary materially from those expressed or implied by the statements herein due to the Company's ability to successfully raise sufficient capital on reasonable terms or at all, available cash on hand and contractual and statutory limitations that could impair our ability to pay future dividends, our ability to complete our pre-clinical or clinical studies and to obtain approval for our product candidates, our ability to successfully defend potential future litigation, changes in local or national economic conditions as well as various additional risks, many of which are now unknown and generally out of the Company's control, and which are detailed from time to time in reports filed by the Company with the SEC, including quarterly reports on Form 10-Q, reports on Form 8-K and annual reports on Form 10-K. BioVie Inc. does not undertake any duty to update any statements contained herein (including any forward-looking statements), except as required by law.
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FAQ
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