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CARSON CITY, Nev., June 04, 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 the formation of a long COVID Advisory Board that will provide the Company with strategic guidance on the design and execution of a Phase 2b trial in patients with long COVID, with funding from the U.S.
内华达州卡森市,2024年6月4日(环球通讯社)--BioVie Inc.(纳斯达克:BIVI),(“BioVie”或“公司”)是一家临床阶段公司,开发用于治疗神经和神经退行性疾病以及晚期肝病的创新药物疗法,今天宣布成立一个长期新型冠状病毒咨询委员会,该委员会将为该公司提供设计和执行长期新型冠状病毒患者2b期试验的战略指导,资金来自美国。
Department of Defense..
国防部。。
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, which include cognitive dysfunction and fatigue, are debilitating and to date there are no therapies proven effective for treatment..
长COVID是一种由SARS-CoV-2病毒引起的急性呼吸道疾病COVID-19的症状持续很长一段时间,通常持续三个月或更长时间。美国疾病控制中心(Centers for Disease Control)最近报告称,目前或之前,美国有1700多万成年人患有长期新型冠状病毒。1包括认知功能障碍和疲劳在内的症状使人衰弱,迄今为止,尚无有效的治疗方法。。
The Advisory Board includes four of the leading experts in long COVID (Michael Peluso, MD, MHS and Steven Deeks, MD from the University of California, San Francisco; Sherry Chou, MD and Igor Koralnik, MD from Northwestern Feinberg School of Medicine in Chicago) and two industry experts in outcomes and neuropsychiatric clinical development (Cynthia Girman, Dr.
该咨询委员会包括四位长期新型冠状病毒的领先专家(加利福尼亚大学旧金山分校的迈克尔·佩卢索医学博士和史蒂文·迪克斯医学博士;芝加哥西北范伯格医学院的谢莉·周医学博士和伊戈尔·科拉尼克医学博士)和两位成果和神经精神临床发展行业专家(辛西娅·吉尔曼博士)。
PH, Founder and President of CERobs Consulting, Dr. Douglas Feltner, former Chief Medical Officer at Kisbee Therapeutics and Exicure Inc). Joseph Palumbo, MD, LFAPA, MACPsych, BioVie’s Chief Medical Officer and Head of Research and Development will chair the Advisory Board..
博士,CERobs Consulting创始人兼总裁,Douglas Feltner博士,Kisbee Therapeutics and Exicure Inc.前首席医疗官)。BioVie首席医疗官兼研发主管JosephPalumbo医学博士、LFAPA、MACPsych将担任顾问委员会主席。。
“We are gratified to have been selected and to have received funding from the DoD to evaluate our novel therapeutic bezisterim in patients with Long COVID,” said Dr. Palumbo. “Bezisterim is an anti-inflammatory and insulin-sensitizer that permeates the blood-brain barrier and could represent a novel oral treatment targeting an underlying cause of long COVID symptoms.
Palumbo博士说:“我们很高兴被选中并获得了国防部的资助,以评估我们在长冠状病毒患者中的新型治疗贝西斯特林。”。Bezisterim是一种抗炎和胰岛素增敏剂,可渗透血脑屏障,可能代表一种针对长期新型冠状病毒症状根本原因的新型口服治疗方法。
Our Scientific Advisory Board will play a pivotal role in guiding and accelerating our program in the currently funded planning phase. We are pleased to have this esteemed group of scientists as collaborators to set science in motion.'.
我们的科学顾问委员会将在目前资助的规划阶段指导和加速我们的计划方面发挥关键作用。我们很高兴有这群受人尊敬的科学家作为合作者,推动科学的发展。”。
Advisory Board
咨询委员会
Michael Peluso, MD, MHS and Steven Deeks, MD are infectious disease clinical researchers at University of California, San Francisco. When the SARS-CoV-2 pandemic emerged, they led the efforts to implement the Long-term Impact of Infection with Novel Coronavirus (LIINC) study examining COVID’s long-term effects on health.
医学博士Michael Peluso和医学博士Steven Deeks是旧金山加利福尼亚大学的传染病临床研究人员。当SARS-CoV-2大流行出现时,他们领导了实施新型冠状病毒感染的长期影响(LIINC)研究,研究新型冠状病毒对健康的长期影响。
LIINC became one of the first studies focused on understanding the biological mechanisms that drive long COVID and has supported over 50 scientific collaborations. Dr. Peluso, Assistant Professor of Medicine, leads a long COVID clinical trial program within LIINC and also oversees the implementation of the NIH’s RECOVER long COVID initiative at UCSF.
LIINC成为首批专注于了解驱动长时间新型冠状病毒的生物学机制的研究之一,并支持了50多项科学合作。医学助理教授佩卢索博士在LIINC内领导一项长期新型冠状病毒临床试验计划,并监督加州大学旧金山分校NIH的恢复长期新型冠状病毒倡议的实施。
Dr. Deeks, Professor of Medicine, was a co-organizer of the 2023 Keystone Symposia Meeting focused on long COVID pathogenesis and treatment..
医学教授迪克斯博士是2023年Keystone专题讨论会的共同组织者,该会议专注于长时间的新型冠状病毒发病机制和治疗。。
Sherry Chou, MD and Igor Koralnik, MD from Northwestern Feinberg School of Medicine in Chicago are experts in the neurological sequalae of COVID infection and were the first to characterize the neurological complications in hospitalized COVID-19 patients in the U.S. Dr. Chou, who is the Chief of Neurocritical Care and Associate Professor of Neurology at Northwestern Feinberg School of Medicine, founded and leads the large Global Consortium Study on Neurological Dysfunction in COVID-19 (GCS-NeuroCOVID) and serves as an invited member to the World Health Organization forum on neurological impacts of COVID-19.
芝加哥西北范伯格医学院医学博士Sherry Chou和医学博士Igor Koralnik是新型冠状病毒感染神经学序列的专家,是美国第一个描述住院新型冠状病毒肺炎患者神经系统并发症的专家。Chou博士是西北范伯格医学院神经重症监护主任和神经病学副教授,成立并领导了全球大型新型冠状病毒肺炎神经功能障碍研究联盟(GCS NeuroCOVID),并应邀参加世界卫生组织新型冠状病毒肺炎神经影响论坛。
Dr Koralnik, who is Chief of Neuro-infectious Disease and Global Neurology in the Department of Neurology at Northwestern Feinberg School of Medicine, created one of the first Neuro COVID-19 clinics in the country where he and his team investigate, diagnose and manage neurological symptoms of long COVID. .
Koralnik博士是西北Feinberg医学院神经病学系神经传染病和全球神经病学的负责人,他和他的团队在该国创建了首批神经新型冠状病毒肺炎诊所之一,在那里他和他的团队调查,诊断和管理长型冠状病毒的神经症状。。
“Through the Northwestern Medicine Comprehensive COVID-19 Center, we have evaluated over 4,000 individuals with Long COVID and more than 2,500 at the NEURO-COVID-19 clinic and have documented the neurocognitive and other significant health challenges that remain without effective treatments” stated Dr.
“通过西北医学综合COVID-19中心,我们评估了4000多名长期COVID患者和NEURO-COVID-19诊所的2500多名患者,并记录了仍然没有有效治疗的神经认知和其他重大健康挑战”,Dr。
Koralnik. “I am excited to join my fellow colleagues to provide guidance to BioVie in the development of this important trial to assess the potential impact of bezisterim in the treatment of long COVID.”.
科拉尔尼克。“我很高兴能与我的同事一起为BioVie提供指导,以开发这项重要的试验,评估贝齐斯特林在治疗长型冠状病毒方面的潜在影响。”。
Cynthia Girman, Dr. PH, Founder and President of CERobs Consulting, has forty years of epidemiology and biostatistical experience in the pharmaceutical industry. She is an expert in study design and methodology for real world evidence, observational non-interventional studies as well as external control arms for clinical trials.
Cynthia Girman博士是CERobs Consulting的创始人和总裁,在制药行业拥有40年的流行病学和生物统计学经验。她是现实世界证据的研究设计和方法学专家,观察性非介入研究以及临床试验的外部控制手段。
Dr. Girman also provides expertise for endpoint strategies for clinical trials, including clinical outcome assessments and patient reported outcomes, and their justification to regulatory bodies. Previously, Dr. Girman served as Executive Director and Head of Data Analytics & Observational Methods in the Center for Observational & Real-World Evidence at Merck Research Laboratories, where she founded the Center of Excellence for Comparative & Outcomes Evidence and one for the Development, Validation, Standardization and Implementation of Endpoints (DEVISE) for clinical trials.
Girman博士还为临床试验的终点策略提供专业知识,包括临床结果评估和患者报告的结果,以及向监管机构证明其合理性。此前,Girman博士曾担任默克研究实验室观察与现实世界证据中心的执行主任兼数据分析与观察方法负责人,她在那里建立了比较与结果证据卓越中心,以及临床试验终点(DEVITE)的开发,验证,标准化和实施中心。
She is currently a member of the Methodology Committee for the Patient Centered Outcome Research Institute..
她目前是以患者为中心的成果研究所方法委员会的成员。。
Dr. Douglas Feltner is a physician-scientist, with over 25 years of experience in clinical drug development and in translational medicine, primarily focused on neurology, psychiatry and neuroscience. Prior to recent positions as Chief Medical Officer at Kisbee Therapeutics and Exicure Inc., Dr. Feltner served as Vice President, Neuroscience Development, for AbbVie, Inc.
道格拉斯·费尔特纳博士是一位内科医生,在临床药物开发和转化医学方面拥有超过25年的经验,主要专注于神经病学、精神病学和神经科学。在最近担任Kisbee Therapeutics and Exicure Inc.首席医疗官之前,Feltner博士曾担任AbbVie,Inc.神经科学开发副总裁。
and Vice President, Global Head of Translational Medicine for Pfizer, Inc. Dr. Feltner earned his M.D., with distinction in research, from the University of Michigan Medical School, did his residency in psychiatry at George Washington University, and was a postdoctoral fellow in the Lab of Mammalian Genes and Development at The National Institute of Child Health and Human Development..
辉瑞公司副总裁兼转化医学全球负责人。费尔特纳博士以优异的研究成绩从密歇根大学医学院获得了医学博士学位,在乔治华盛顿大学做了精神病学住院医师,并且是美国国家儿童健康与人类发展研究所哺乳动物基因与发育实验室的博士后研究员。。
'I am so delighted for our team to be working with and learning from our selected experts,' said BioVie CEO Cuong Do. 'The Advisory Board brings expertise to help us design the exploratory Phase 2b trial to assess how bezisterim may address the cognitive and fatigue symptoms of long Covid. Finalization of the protocol and obtaining the necessary regulatory approvals will trigger a milestone meeting with the PRMP programmatic panel that is required to allow us to exercise the award option of $12.6 million in the approved budget to conduct the clinical trial.” 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..
BioVie首席执行官Cuong Do说:“我很高兴我们的团队能够与我们选定的专家合作并向他们学习。咨询委员会带来了专业知识,帮助我们设计探索性的2b期试验,以评估贝齐斯特林如何解决长冠状病毒的认知和疲劳症状。最终确定协议并获得必要的监管批准将引发与PRMP计划小组的里程碑式会议,该会议要求我们在批准的预算中行使1260万美元的奖励选择权,以进行临床试验。”慢性炎症是研究人员提出的解释长型冠状病毒症状持续存在的主要假设之一。3特别是在患有“脑雾”的个体中,持续的全身炎症和持续的局部血脑屏障(BBB)功能障碍是关键的生理特征。贝齐斯特林渗透BBB,并已被证明通过激活NF-kB来调节炎症,因此代表了一种针对疑似长型冠状病毒症状根本原因的新型口服治疗。。
The preliminary plan is to conduct a Phase 2b, randomized (1:1), placebo-controlled, multicenter trial to evaluate the safety and tolerability of 3 months of treatment with bezisterim and assess the ability of this treatment to reduce the neurocognitive symptoms that are associated with long COVID, in approximately 200 patients..
初步计划是进行一项2b期,随机(1:1),安慰剂对照,多中心试验,以评估贝齐斯特林治疗3个月的安全性和耐受性,并评估这种治疗在大约200名患者中减少与长COVID相关的神经认知症状的能力。。
Terms of the Department of Defense Award
国防部奖励条款
The work is supported by the Assistant Secretary of Defense for Health Affairs endorsed by the Department of Defense, in the amount of $499,200 for the planning phase with the option, if approved, to receive an additional $12.6 million, to initiate a clinical trial once the planning phase has concluded and milestones have been met, through the Peer-Reviewed Medical Research Program under Award No.
这项工作得到了国防部批准的负责卫生事务的助理国防部长的支持,计划阶段的资金为49.92万美元,如果获得批准,可以选择额外获得1260万美元,一旦计划阶段结束并达到里程碑,通过第号奖项的同行评审医学研究计划启动临床试验。
HT9425-24-1-0113. Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the Assistant Secretary of Defense for Health Affairs or the Department of Defense..
HT9425-24-1-0113。意见、解释、结论和建议均为作者的意见、解释、结论和建议,不一定得到国防部卫生事务助理部长或国防部的认可。。
About Long COVID
关于长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.
长COVID是一种由SARS-CoV-2病毒引起的急性呼吸道疾病COVID-19的症状持续很长一段时间,通常持续三个月或更长时间。常见症状包括持续的嗅觉和味觉丧失,听力下降,极度疲劳和“脑雾”,尽管也有持续的心血管和呼吸系统问题,肌肉无力和神经系统问题的记录。
The Centers for Disease Control recently reported that 6.8% of adults in the United States (more than 17 million individuals) currently or previously have long COVID.1 The loss in quality of life and earnings and increased medical costs has an enormous economic impact estimated to be $3.7 trillion.2 To date there are no non-pharmacological or pharmacological therapies proven effective for treatment of long COVID..
美国疾病控制中心最近报告称,目前或之前,美国有6.8%的成年人(超过1700万人)患有长期新型冠状病毒。1生活质量和收入的下降以及医疗费用的增加产生了巨大的经济影响,估计为3.7万亿美元。2迄今为止,还没有非药物或药物疗法被证明对治疗长期新型冠状病毒有效。。
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..
慢性炎症是研究人员提出的解释长冠状病毒症状持续存在的主要假设之一。3与炎症相关的蛋白质(LGALS9,CCL21,CCL22,TNF,CXCL10和CD48)和免疫调节(IL1RN和CD22)的表达已被证明在长冠状病毒患者与完全恢复的个体中升高[4]。特别是在“脑雾”患者中,持续的全身炎症和持续的局部血脑屏障(BBB)功能障碍是关键的生理特征。因此,调节炎症和调节BBB完整性的药物可能代表治疗长冠状病毒神经症状的潜在治疗机制。。
About Bezisterim
Empty关于
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.
Bezisterim(NE3107)是一种口服生物可利用,BBB可渗透的胰岛素增敏剂,也具有抗炎作用。此外,它不具有免疫抑制作用,药物间相互作用的风险较低。Bezisterim有可能减轻长期新型冠状病毒的症状,包括疲劳和认知功能障碍。
Persistently circulating viral spike proteins are believed to trigger TLR-4 driven activation of NFκB and the subsequent expression of inflammatory cytokines (IL-6, TNF, IFNγ). NE3107 has been shown to modulate the activation of NFkB and thus modulate inflammation..
据信持续循环的病毒棘突蛋白会触发TLR-4驱动的NFκB活化和随后的炎性细胞因子(IL-6,TNF,IFNγ)的表达。NE3107已被证明可以调节NFkB的激活,从而调节炎症。。
Bezisterim is 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).
Bezisterim正在接受阿尔茨海默病(AD)和帕金森病(PD)的调查。BioVie在其3期随机,双盲,安慰剂对照,平行组,多中心研究中进行并报告了疗效数据,以评估轻度至中度AD患者的bezisterim(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.
2022年12月,阿尔茨海默病临床试验(CTAD)年会上介绍了一项由研究者发起的第二阶段试验(NCT05227820)的结果,该试验显示贝齐斯特林治疗的患者认知能力和生物标志物水平有所改善。估计有600万美国人患有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.
帕金森病患者贝齐斯特林的第二阶段研究(NCT05083260)已经完成,2023年3月在瑞典哥德堡举行的AD/PD™2023阿尔茨海默氏病和帕金森氏病及相关神经系统疾病国际会议上提供的数据显示,贝齐斯特林和左旋多巴联合治疗的患者的“早晨”症状显着改善,运动控制有临床意义。
patients treated with levodopa alone, and no drug-related adverse events..
单独使用左旋多巴治疗的患者,无药物相关不良事件。。
About BioVie Inc.
关于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 NFκB (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).
BioVie Inc.(纳斯达克股票代码:BIVI)是一家临床阶段公司,开发用于治疗神经和神经退行性疾病以及晚期肝病的创新药物疗法。在神经退行性疾病中,该公司的候选药物bezisterim抑制ERK和NFκB的炎症激活(例如TNF信号传导),导致神经炎症和胰岛素抵抗,但不抑制其稳态功能(例如胰岛素信号传导和神经元生长和存活)。
Both are drivers of AD and PD. In liver disease, the Company’s Orphan drug candidate BIV201 (continuous infusion terlipressin), with U.S. Food and Drug Administration (“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.
两者都是AD和PD的驱动因素。在肝病方面,该公司的孤儿候选药物BIV201(持续输注特利加压素)具有美国食品和药物管理局(“FDA”)的快速通道状态,正在接受FDA关于设计BIV201治疗慢性肝硬化腹水的3期临床试验的指导进行评估和讨论。
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..
该活性药物在美国和大约40个国家被批准用于治疗晚期肝硬化的相关并发症。有关更多信息,请访问www.bioviepharma.com。。
Forward-Looking Statements
前瞻性声明
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.
本新闻稿包含前瞻性陈述,可以用“期望”、“期待”、“预期”、“打算”、“计划”、“相信”、“寻求”、“估计”、“意志”、“项目”或类似含义的词语来识别。尽管BioVie Inc.认为此类前瞻性陈述是基于合理的假设,但它无法保证其预期会实现。
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.
实际结果可能与本文声明中明示或暗示的结果有很大差异,这是由于公司有能力以合理的条件或根本不可能成功筹集足够的资本,现有现金以及可能损害我们支付未来股息的能力的合同和法定限制,我们完成临床前或临床研究以及获得候选产品批准的能力,我们成功防御未来潜在诉讼的能力,当地或国家经济状况的变化以及各种额外风险,其中许多风险目前尚不清楚,通常不在公司的控制范围内,这些风险在公司向美国证券交易委员会提交的报告中不时详细说明,包括表10-Q的季度报告,表8-K的报告和表10的年度报告-K。
BioVie Inc. does not undertake any duty to update any statements contained herein (including any forward-looking statements), except as required by law..
除法律要求外,BioVie Inc.不承担更新本文所载任何声明(包括任何前瞻性声明)的任何义务。。
References
参考文献
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2 Cutler, David M. 2022 The economic costs of Long COVID: An update. long_covid_update_7-22.pdf (harvard.edu)
2 Cutler,David M.2022长冠状病毒的经济成本:更新。long\u covid\u update\u 7-22.pdf(哈佛大学教育部)
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For Investor Relations Inquiries:
投资者关系查询:
Bruce Mackle
Bruce Mackle
Managing Director, LifeSci Advisors, LLC
LifeSci Advisors,LLC董事总经理
bmackle@lifesciadvisors.com
bmackle@lifesciadvisors.com
For Media Relations Inquiries:
对于媒体关系查询:
Melyssa Weible
Melyssa Weible
Managing Partner, Elixir Health Public Relations
Elixir Health公共关系管理合伙人
mweible@elixirhealthpr.com
mweible@elixirhealthpr.com