BioVie Secures All Scientific Approvals Needed to Receive Additional $12.6 Million of Grant Funding to Launch Planned Phase 2 Trial to Evaluate Bezisterim in Long COVID
BioVie Inc. (NASDAQ: BIVI) has secured all scientific approvals needed to receive an additional $12.6 million in grant funding from the U.S. Department of Defense for a planned Phase 2 trial of bezisterim in long COVID. The U.S. Army Medical Research and Development Command, Office of Human Research Oversight (OHRO) approved BioVie's plan to evaluate bezisterim for treating neurological symptoms associated with long COVID. This approval follows the FDA's Safe to Proceed designation in August 2024.
The Phase 2 study, expected to commence by early 2025, will be a randomized, placebo-controlled trial involving approximately 200 patients to assess the safety, tolerability, and potential efficacy of bezisterim in reducing neurocognitive symptoms of long COVID over a 3-month treatment period. Bezisterim, which can cross the blood-brain barrier, targets inflammation via NF-kB activation, addressing a suspected underlying cause of long COVID symptoms.
BioVie Inc. (NASDAQ: BIVI) ha ottenuto tutte le approvazioni scientifiche necessarie per ricevere un ulteriore 12,6 milioni di dollari in finanziamenti a fondo perduto dal Dipartimento della Difesa degli Stati Uniti per una prevista fase 2 della sperimentazione del bezisterim nel lungo COVID. L'Ufficio di Ricerca Umana della Command Medical Research and Development dell'Esercito degli Stati Uniti (OHRO) ha approvato il piano di BioVie per valutare il bezisterim nel trattamento dei sintomi neurologici associati al lungo COVID. Questa approvazione segue la designazione Safe to Proceed della FDA di agosto 2024.
Lo studio di fase 2, che dovrebbe iniziare entro inizio 2025, sarà uno studio randomizzato controllato con placebo che coinvolgerà circa 200 pazienti per valutare la sicurezza, la tollerabilità e la potenziale efficacia del bezisterim nella riduzione dei sintomi neurocognitivi del lungo COVID durante un periodo di trattamento di 3 mesi. Il bezisterim, che può attraversare la barriera emato-encefalica, agisce sull'infiammazione attivando l'NF-kB, affrontando una causa sottostante sospettata dei sintomi del lungo COVID.
BioVie Inc. (NASDAQ: BIVI) ha asegurado todas las aprobaciones científicas necesarias para recibir 12.6 millones de dólares adicionales en financiación de subvenciones del Departamento de Defensa de los EE. UU. para un ensayo de fase 2 planificado del bezisterim en COVID prolongado. El Comando de Investigación y Desarrollo Médico del Ejército de los EE. UU., Oficina de Supervisión de Investigación Humana (OHRO), aprobó el plan de BioVie para evaluar el bezisterim para el tratamiento de síntomas neurológicos asociados con el COVID prolongado. Esta aprobación sigue a la designación Safe to Proceed de la FDA en agosto de 2024.
El estudio de fase 2, que se espera que comience a principios de 2025, será un ensayo controlado aleatorio con placebo que involucrará aproximadamente 200 pacientes para evaluar la seguridad, tolerabilidad y posible eficacia del bezisterim en la reducción de síntomas neurocognitivos del COVID prolongado durante un periodo de tratamiento de 3 meses. El bezisterim, que puede cruzar la barrera hematoencefálica, se dirige a la inflamación a través de la activación de NF-kB, abordando una posible causa subyacente de los síntomas del COVID prolongado.
BioVie Inc. (NASDAQ: BIVI)는 장기 COVID 치료를 위한 bezisterim의 2단계 시험을 계획하면서 미국 국방부로부터 추가 1260만 달러의 보조금 자금을 받기 위해 필요한 모든 과학적 승인을 확보했습니다. 미국 육군 의료 연구 개발 사령부 인간 연구 감독 사무소(OHRO)는 BioVie의 장기 COVID와 관련된 신경학적 증상 치료를 위한 bezisterim 평가 계획을 승인했습니다. 이 승인은 2024년 8월 FDA의 안전 진행(Safe to Proceed) 지정을 따릅니다.
예상되는 2단계 연구는 2025년 초에 시작될 것으로 보이며, 약 200명의 환자를 대상으로 안전성, 내약성 및 치료 기간 3개월 동안 장기 COVID의 신경인지 증상 감소에 대한 bezisterim의 가능한 효능을 평가하는 무작위 대조군 시험이 될 것입니다. bezisterim은 혈액-뇌 장벽을 넘어설 수 있으며, NF-kB 활성화를 통해 염증을 목표로 하여 장기 COVID 증상의 의심되는 근본 원인을 다룹니다.
BioVie Inc. (NASDAQ: BIVI) a obtenu toutes les approbations scientifiques nécessaires pour recevoir un financement supplémentaire de 12,6 millions de dollars du Département de la Défense des États-Unis pour un essai de phase 2 prévu du bezisterim dans le cadre du COVID long. Le Commandement de la recherche et du développement médical de l'Armée des États-Unis, Bureau de la supervision de la recherche humaine (OHRO), a approuvé le plan de BioVie pour évaluer le bezisterim dans le traitement des symptômes neurologiques associés au COVID long. Cette approbation fait suite à la désignation Safe to Proceed de la FDA en août 2024.
L'étude de phase 2, qui devrait commencer début 2025, sera un essai contrôlé randomisé avec placebo impliquant environ 200 patients pour évaluer la sécurité, la tolérance et l'efficacité potentielle du bezisterim dans la réduction des symptômes neurocognitifs du COVID long pendant une période de traitement de 3 mois. Le bezisterim, qui peut traverser la barrière hémato-encéphalique, cible l'inflammation par l'activation de NF-kB, abordant une cause sous-jacente suspectée des symptômes du COVID long.
BioVie Inc. (NASDAQ: BIVI) hat alle wissenschaftlichen Genehmigungen erhalten, die erforderlich sind, um weitere 12,6 Millionen Dollar an Fördermitteln vom US-Verteidigungsministerium für eine geplante Phase-2-Studie zu bezisterim bei Long COVID zu erhalten. Das Army Medical Research and Development Command, Office of Human Research Oversight (OHRO), genehmigte BioVies Plan zur Bewertung von bezisterim zur Behandlung neurologischer Symptome, die mit Long COVID verbunden sind. Diese Genehmigung folgt auf die Safe to Proceed-Bezeichnung der FDA im August 2024.
Die Phase-2-Studie, die voraussichtlich Anfang 2025 beginnen wird, wird eine randomisierte, placebo-kontrollierte Studie sein, an der etwa 200 Patienten teilnehmen werden, um die Sicherheit, Verträglichkeit und mögliche Wirksamkeit von bezisterim bei der Reduzierung neurokognitiver Symptome von Long COVID über einen Zeitraum von 3 Monaten zu bewerten. bezisterim, das die Blut-Hirn-Schranke überwinden kann, zielt auf Entzündungen durch NF-kB-Aktivierung ab und adressiert einen vermuteten zugrunde liegenden Grund für die Symptome von Long COVID.
- Secured $12.6 million in additional grant funding from the U.S. Department of Defense
- Obtained all necessary scientific approvals for Phase 2 trial of bezisterim in long COVID
- FDA approved the study as Safe to Proceed in August 2024
- Phase 2 trial planned to commence by early 2025
- Bezisterim's mechanism of action targets a suspected underlying cause of long COVID symptoms
- None.
Insights
BioVie's approval from OHRO marks a significant milestone in advancing bezisterim for long COVID treatment. This $12.6 million grant from the DOD demonstrates strong governmental support for addressing this pressing health issue. The planned Phase 2 trial with 200 patients is a substantial step in evaluating bezisterim's efficacy against neurocognitive symptoms.
Bezisterim's potential to modulate inflammation via NF-kB activation and its ability to cross the blood-brain barrier make it a promising candidate. With over 17 million U.S. adults affected by long COVID, the market potential is significant. However, investors should note that the trial is not expected to commence until early 2025, indicating a long runway before potential commercialization.
The securing of
However, with the trial not starting until early 2025, BioVie faces a significant cash burn period. Investors should scrutinize the company's current cash position and burn rate. The long timeline to potential commercialization means any revenue impact is distant. While the long COVID market is substantial, the stock may face near-term pressure due to the extended development timeline.
Bezisterim's potential in treating long COVID's neurocognitive symptoms is intriguing. Its ability to cross the blood-brain barrier and modulate inflammation via NF-kB activation directly addresses the hypothesized mechanisms of 'brain fog' in long COVID patients. This targeted approach could provide a significant advantage over current symptomatic treatments.
The 200-patient trial size is robust for a Phase 2 study, potentially providing strong efficacy signals if successful. However, the complex nature of long COVID and the variability in patient experiences may present challenges in demonstrating clear benefits. The 3-month treatment duration is reasonable but may need extension in future studies to fully assess long-term efficacy and safety.
Approval from U.S. Army Medical Research and Development Command, Office of Human Research Oversight is the last scientific milestone needed for Company to receive
bulk of
Company anticipates Phase 2 trial to commence by early 2025
CARSON CITY, Nev., Sept. 16, 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. Army Medical Research and Development Command, Office of Human Research Oversight, (OHRO) has approved BioVie’s plan to evaluate bezisterim for the treatment of neurological symptoms that are associated with long COVID. FDA had previously reviewed and approved the study as Safe to Proceed in August 2024. Approval from OHRO is the last scientific review milestone needed for the Company to receive the additional
The planned Phase 2 study is a 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.
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 more than 17 million adults in the United States currently or previously had long COVID.1 Symptoms include cognitive dysfunction and fatigue and are debilitating. No therapies have proven effective for treatment to date. Chronic inflammation is one of the main hypotheses that researchers have proposed to explain the persistence of symptoms in long COVID.3 Specifically in individuals with “brain fog,” sustained systemic inflammation and persistent localized blood-brain-barrier (BBB) dysfunction are key physiological features.5 Bezisterim permeates the BBB and has been shown to modulate inflammation via the activation of NF-kB, thus representing a novel oral treatment targeting a suspected underlying cause of long COVID symptoms.
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-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 Ford 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 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:
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Managing Director, LifeSci Advisors, LLC
bmackle@lifesciadvisors.com
For Media Relations Inquiries:
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mweible@elixirhealthpr.com
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