BioVie Announces FDA Authorization of Investigational New Drug Application for Phase 2 Trial to Evaluate Bezisterim in Long COVID
BioVie Inc. (NASDAQ: BIVI) has received FDA authorization for its Investigational New Drug (IND) application to evaluate bezisterim in a Phase 2 trial for treating neurological symptoms associated with long COVID. This milestone puts BioVie on track to receive an additional $12.6 million in grant funding from the U.S. Department of Defense and initiate the trial. The planned study will be a randomized, placebo-controlled, multicenter trial involving approximately 200 patients to assess the safety and efficacy of bezisterim over a 3-month treatment period.
Long COVID affects about 5.5% of U.S. adults, with approximately 3.6 million people reporting significant activity modifications due to the illness. Bezisterim's potential to modulate inflammation by activating NF-kB and its ability to permeate the blood-brain barrier make it a promising candidate for addressing the underlying mechanisms of long COVID symptoms.
BioVie Inc. (NASDAQ: BIVI) ha ricevuto l'autorizzazione dalla FDA per la sua domanda di Nuovo Farmaco Investigativo (IND) per valutare bezisterim in uno studio di fase 2 per trattare i sintomi neurologici associati al long COVID. Questo traguardo mette BioVie sulla buona strada per ricevere ulteriori $12,6 milioni in finanziamenti a fondo perduto dal Dipartimento della Difesa degli Stati Uniti e avviare lo studio. Lo studio pianificato sarà un trial randomizzato, controllato con placebo, multicentrico che coinvolgerà circa 200 pazienti per valutare la sicurezza e l'efficacia del bezisterim durante un periodo di trattamento di 3 mesi.
Il long COVID colpisce circa il 5,5% degli adulti negli Stati Uniti, con circa 3,6 milioni di persone che segnalano modifiche significative delle attività a causa della malattia. Il potenziale di bezisterim di modulare l'infiammazione attivando NF-kB e la sua capacità di permeare la barriera emato-encefalica lo rendono un candidato promettente per affrontare i meccanismi sottostanti dei sintomi del long COVID.
BioVie Inc. (NASDAQ: BIVI) ha recibido autorización de la FDA para su solicitud de Nuevo Medicamento Investigacional (IND) para evaluar bezisterim en un ensayo de fase 2 para tratar síntomas neurológicos asociados con el long COVID. Este hito pone a BioVie en camino de recibir $12.6 millones adicionales en financiación de subvenciones del Departamento de Defensa de EE. UU. y de iniciar el ensayo. El estudio planeado será un ensayo aleatorizado, controlado con placebo, multicéntrico que involucrará aproximadamente a 200 pacientes para evaluar la seguridad y eficacia del bezisterim durante un período de tratamiento de 3 meses.
El long COVID afecta a aproximadamente el 5.5% de los adultos en EE. UU., con alrededor de 3.6 millones de personas reportando modificaciones significativas en su actividad debido a la enfermedad. El potencial de bezisterim para modular la inflamación activando NF-kB y su capacidad para permeabilizar la barrera hematoencefálica lo convierten en un candidato prometedor para abordar los mecanismos subyacentes de los síntomas del long COVID.
BioVie Inc. (NASDAQ: BIVI)는 long COVID와 관련된 신경학적 증상을 치료하기 위한 2상 시험에서 bezisterim의 연구 개발 신약(IND) 신청에 대해 FDA의 승인을 받았습니다. 이 이정표는 BioVie가 미국 국방부로부터 추가로 $12.6백만의 보조금을 받고 이 시험을 시작할 수 있도록 하고 있습니다. 계획된 연구는 약 200명의 환자가 참여하는 무작위 배정, 위약 대조, 다기관 시험이며, 3개월 치료 기간 동안 bezisterim의 안전성과 효능을 평가할 것입니다.
Long COVID는 약 미국 성인의 5.5%에게 영향을 미치며, 약 360만 명이 이 질병으로 인해 활동에 상당한 수정이 필요하다고 보고하고 있습니다. NF-kB를 활성화하여 염증을 조절할 수 있는 bezisterim의 잠재력과 혈액-뇌 장벽을 통과할 수 있는 능력은 long COVID 증상의 근본적인 메커니즘을 해결하는 데 있어 유망한 후보로 만듭니다.
BioVie Inc. (NASDAQ: BIVI) a reçu l'autorisation de la FDA pour son application de Nouveau Médicament Investigational (IND) afin d'évaluer bezisterim dans un essai de phase 2 pour traiter les symptômes neurologiques associés au long COVID. Ce jalon met BioVie sur la voie de recevoir 12,6 millions de dollars supplémentaires en financement de subventions du Département de la Défense des États-Unis et de lancer l'essai. L'étude prévue sera un essai randomisé, contrôlé par placebo, multicentrique impliquant environ 200 patients pour évaluer la sécurité et l'efficacité de bezisterim sur une période de traitement de 3 mois.
Le long COVID affecte environ 5,5% des adultes aux États-Unis, avec environ 3,6 millions de personnes signalant des modifications significatives de leurs activités en raison de la maladie. Le potentiel de bezisterim à moduler l'inflammation en activant NF-kB et sa capacité à traverser la barrière hémato-encéphalique en font un candidat prometteur pour aborder les mécanismes sous-jacents des symptômes du long COVID.
BioVie Inc. (NASDAQ: BIVI) hat von der FDA die Genehmigung für seinen Antrag auf ein Investigational New Drug (IND) erhalten, um bezisterim in einer Phase-2-Studie zur Behandlung neurologischer Symptome, die mit long COVID verbunden sind, zu evaluieren. Dieser Meilenstein bringt BioVie auf den Weg, zusätzliche 12,6 Millionen USD an Fördergeldern vom US-Verteidigungsministerium zu erhalten und die Studie zu beginnen. Die geplante Studie wird eine randomisierte, placebokontrollierte, multizentrische Studie sein, an der etwa 200 Patienten teilnehmen werden, um die Sicherheit und Wirksamkeit von bezisterim über einen Zeitraum von 3 Monaten zu bewerten.
Long COVID betrifft etwa 5,5% der Erwachsenen in den USA, wobei etwa 3,6 Millionen Menschen signifikante Änderungen in ihren Aktivitäten aufgrund der Krankheit melden. Das Potenzial von bezisterim zur Modulation von Entzündungen durch Aktivierung von NF-kB und seine Fähigkeit, die Blut-Hirn-Schranke zu durchdringen, machen es zu einem vielversprechenden Kandidaten zur Behandlung der zugrunde liegenden Mechanismen der Symptome von long COVID.
- FDA authorization received for IND application to evaluate bezisterim in Phase 2 trial for long COVID
- Additional $12.6 million in grant funding expected from U.S. Department of Defense
- Phase 2 trial to involve approximately 200 patients, assessing safety and efficacy of bezisterim
- Bezisterim shows promise in addressing underlying inflammation mechanisms of long COVID
- No proven effective therapies for long COVID treatment to date
Insights
The FDA's authorization of BioVie's IND application for bezisterim in long COVID is a significant development. This Phase 2 trial aims to address a critical unmet medical need, as
The focus on bezisterim's anti-inflammatory properties aligns with the growing evidence suggesting inflammation as a key driver of long COVID symptoms. The drug's ability to permeate the blood-brain barrier and modulate inflammation via NF-kB activation presents a novel approach to targeting the suspected underlying cause of neurocognitive symptoms.
If successful, this trial could potentially benefit millions of patients and open up a substantial market opportunity for BioVie. However, investors should note that Phase 2 trials still carry significant risks and efficacy remains to be proven.
This FDA authorization is a positive development for BioVie, potentially accelerating their research timeline and unlocking additional funding. The company is now on track to receive an extra
The long COVID market represents a substantial opportunity, with an estimated 3.6 million Americans experiencing activity-limiting symptoms. If bezisterim proves effective, it could capture a significant share of this untapped market.
However, investors should remain cautious. While this news is promising, BioVie is still a clinical-stage company with no approved products. The outcome of this Phase 2 trial will be important in determining the company's future prospects and potential revenue streams.
Authorization expands use of bezisterim in a Phase 2, placebo-controlled, multicenter trial assessing bezisterim’s impact on neurological symptoms associated with long COVID
Key milestone reached ahead of schedule, with BioVie on track to receive additional
Recent Centers for Disease Control and Prevention survey estimated over
CARSON CITY, Nev., Sept. 03, 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 the U.S. Food and Drug Administration (FDA) has authorized the Company’s Investigational New Drug (“IND”) application to evaluate bezisterim for the treatment of neurological symptoms that are associated with long COVID. Receipt of this FDA authorization puts the Company ahead of schedule and on track to receive an additional
“We are delighted to announce that the FDA has authorized our IND application for bezisterim, allowing us to study a novel, anti-inflammatory approach for the treatment of the debilitating neurocognitive symptoms associated with long COVID,” said Cuong Do, BioVie’s President and CEO. “A growing body of evidence points to inflammation as a key driver of long COVID, and we believe that bezisterim has shown promise in addressing these underlying mechanisms. This is a significant milestone that brings us closer to exploring how bezisterim could help patients with this debilitating condition.”
The planned Phase 2 study is a randomized (1:1), placebo-controlled, multicenter trial in approximately 200 patients to evaluate the safety and tolerability of 3 months of treatment with bezisterim and the potential ability to reduce the neurocognitive symptoms associated with 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. The Centers for Disease Control recently reported that around
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, in the amount of
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, hearing loss, 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
Chronic inflammation is one of the main hypotheses that researchers have proposed to explain the persistence of symptoms in long COVID.3 The expression of proteins associated with inflammation (LGALS9, CCL21, CCL22, TNF, CXCL10 and CD48) and immune regulation (IL1RN and CD22) have been shown to be elevated in individuals with long COVID versus full-recovered individuals.4 Specifically in individuals with “brain fog,” sustained systemic inflammation and persistent localized blood-brain-barrier (BBB) dysfunction are key physiological features.5 Thus, drugs modulating inflammation, and that work to regulate the BBB integrity, could represent potential therapeutic mechanisms for treating neurological symptoms of long COVID.
About Bezisterim
Bezisterim (NE3107) is an orally bioavailable, BBB-permeable, insulin-sensitizer that is also anti-inflammatory. In addition, it is not immunosuppressive and has a low risk of drug-to-drug interaction. Bezisterim has the potential to reduce symptoms of long COVID, including fatigue and cognitive dysfunction. Persistently circulating viral spike proteins are believed to trigger TLR-4 driven activation of NFkB and the subsequent expression of inflammatory cytokines (IL-6, TNF, IFNg). NE3107 has been shown to modulate the activation of NFkB and thus modulate inflammation.
Bezisterim is also being investigated for Alzheimer’s disease (“AD”) and Parkinson’s disease (“PD”). BioVie has conducted and reported efficacy data on its Phase 3 randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate bezisterim in patients who have mild-to-moderate AD (NCT04669028). Results of a Phase 2 investigator-initiated trial (NCT05227820) showing bezisterim-treated patients experienced improved cognition and biomarker levels were presented at the Clinical Trials on Alzheimer’s Disease (CTAD) annual conference in December 2022. An estimated six million Americans suffer from AD. A Phase 2 study of bezisterim in PD (NCT05083260) has been completed, and data presented at the AD/PD™ 2023 International Conference on Alzheimer’s and Parkinson’s Diseases and related neurological disorders in Gothenburg, Sweden in March 2023 showed significant improvements in “morning on” symptoms and clinically meaningful improvement in motor control in patients treated with a combination of bezisterim and levodopa vs. patients treated with levodopa alone, and no drug-related adverse events.
About BioVie Inc.
BioVie Inc. (NASDAQ: BIVI) is a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease. In neurodegenerative disease, the Company’s drug candidate bezisterim inhibits inflammatory activation of ERK and NFkB (e.g., TNF signaling) that leads to neuroinflammation and insulin resistance, but not their homeostatic functions (e.g., insulin signaling and neuron growth and survival). Both are drivers of AD and PD. 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 treatment of ascites due to chronic liver cirrhosis. 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.
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.
References
1 U.S. Census Bureau. Household Pulse Survey, 2022-2024. https://www.cdc.gov/nchs/covid19/pulse/long-covid.htm.
2 Cutler, David M. 2022 The economic costs of Long COVID: An update. long_covid_update_7-22.pdf (harvard.edu)
3 Evans RA, Leavy OC, Richardson M, et al. Clinical characteristics with inflammation profiling of Long-COVID and association with one-year recovery following hospitalisation in the UK: a prospective observational study. The Lancet Respiratory Medicine. 2022;10(8):761-775.
4 Yin K, Peluso MJ, Luo X, et al. Long COVID manifests with T cell dysregulation, inflammation and an uncoordinated adaptive immune response to SARS-CoV-2. Nature Immunology. 2024;25:218-225.
5 Greene C, Connoly R, Brennan D, et al. Blood–brain barrier disruption and sustained systemic inflammation in individuals with long COVID-associated cognitive impairment. Nature Neuroscience. 2024;27:421-432.
For Investor Relations Inquiries:
Bruce Mackle
Managing Director, LifeSci Advisors, LLC
bmackle@lifesciadvisors.com
For Media Relations Inquiries:
Melyssa Weible
Managing Partner, Elixir Health Public Relations
mweible@elixirhealthpr.com
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