BioVie to Present Overview of Bezisterim Clinical Data on Longevity at 11th Aging Research and Drug Discovery Meeting
BioVie to Present Overview of Bezisterim Clinical Data on Longevity at 11th Aging Research and Drug Discovery Meeting
Presentation to showcase potential impact of bezisterim on biological age, gene expression and measures of aging-related diseases from growing body of clinical evidence
展示致力於展示bezisterim對生物年齡、基因表達及衰老相關疾病的潛在影響,該藥在不斷增長的臨床證據中得到證實。
CARSON CITY, Nev., Aug. 13, 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 a poster presentation will be shared at the 11th Aging Research and Drug Discovery Meeting (ARDD 2024) being held August 26-30, 2024 in Copenhagen, Denmark.
內華達州卡爾森城,2024年8月13日(環球社區新聞)——正在開發治療神經系統和神經退行性疾病以及高級肝病創新藥物療法的臨床階段公司BioVie Inc. (納斯達克:BIVI)(以下簡稱「BioVie」或「公司」)今天宣佈,一份海報展示將在2024年8月26日至30日舉行的第11屆衰老研究與藥物研發會議(ARDD2024)中分享。該展示將在丹麥哥本哈根舉行。
The presentation "Bezisterim Effects on Biological Age, Alzheimer's Epigenetics, and Neurologic Assessments" will provide an overview of clinical data to-date on bezisterim, focusing on various analyses and measurements related to longevity and its ability to affect the biological aging process. The presentation will be given by Christopher L. Reading, BioVie's Senior Vice President, Alzheimer's Disease Program, on Tuesday, August 27 from 14:40 - 15:00 CEST.
展示名爲「Bezisterim Effects on Biological Age, Alzheimer's Epigenetics, and Neurologic Assessments」的海報,將提供關於bezisterim迄今爲止的臨床數據概述,重點關注與長壽及其影響生物老化過程相關的各種分析和測量。此次展示將由BioVie老年癡呆症項目高級副總裁Christopher L. Reading於8月27日星期二CEST時間14:40-15:00進行。
Details of the presented data and conclusions will be announced once the presentation is made public at the conference.
一旦在會議上公佈了介紹的數據和結論,將會進行公告。
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.
關於Bezisterim
Bezisterim(NE3107)是一種口服可用、BBb可滲透、胰島素增敏劑,也具有抗炎作用。此外,它不具有免疫抑制作用,並且具有很低的藥物相互作用風險。Bezisterim有潛力減輕長期COVID的症狀,包括疲勞和認知功能障礙。持續循環的病毒棘蛋白被認爲會觸發TLR-4驅動的NFkb的激活以及炎症細胞因子(IL-6,TNF,IFNg)的表達。 NE3107已被證明可以調節NFkb的激活,從而調節炎症反應。
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). 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.
Bezisterim正在研究用於治療阿爾茨海默病(AD)和帕金森病(PD)。BioVie已對其進行了第3階段的隨機、雙盲、安慰劑對照、平行組多中心研究,評估Bezisterim治療輕度至中度AD患者的療效(NCT04669028)。一項第2期調查員發起的試驗結果(NCT05227820)表明,Bezisterim治療的患者認知和生物標誌物水平得到了改善,這些結果已於2022年12月在臨床阿爾茨海默病(CTAD)年會上宣佈。大約有600萬美國人患有AD。Bezisterim在PD的2期研究(NCT05083260)已經完成,2023年3月在瑞典哥德堡舉行的阿爾茨海默病和帕金森病及相關神經系統疾病國際會議上公佈的數據顯示,與單獨使用左旋多巴的患者相比,聯合使用Bezisterim和左旋多巴的患者在「早晨起牀後」症狀和臨床上有意義的運動控制方面有顯著改善,沒有藥物相關的不良事件。
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 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. 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 .
關於BioVie Inc.
BioVie公司(NASDAQ: BIVI)是一家專注於開發創新藥物療法用於治療神經系統和神經退行性疾病以及晚期肝臟疾病的臨床階段公司。在神經退行性疾病中,該公司的藥物候選Bezisterim抑制ERk和NFkb(例如TNF信號)的炎性激活,從而導致神經炎症和胰島素抵抗,但不影響它們的穩態功能(例如胰島素信號傳導和神經元的生長和存活)。這兩個因素都是阿爾茨海默病和帕金森病的驅動因素。在肝臟疾病方面,美國食品藥品監督管理局(FDA)快速通道的孤兒藥物候選BIV201(持續靜脈注射曲壓利)正在進行評估,並根據FDA的指導意見,討論了BIV201治療由慢性肝硬化引起的腹水的3期臨床試驗設計。該活性劑在美國和大約40個國家已被批准用於晚期肝硬化相關併發症的治療。欲了解更多信息,請訪問。
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. In this press release, forward-looking statements include, but are not limited to, the potential impact of bezisterim on cognition and function among study participants and topline data from the bezisterim trial. 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.
前瞻性聲明
本新聞稿包含前瞻性聲明,這些聲明可能通過諸如「期望」,「期待」,「預計」「計劃」,「相信」,「尋求」,「估計」,「將」,「項目」或類似意義的單詞進行識別。在本新聞稿中,前瞻性聲明包括但不限於bezisterim對研究參與者認知和功能方面的潛在影響以及bezisterim試驗數據的最終結果。儘管BioVie Inc.認爲這些前瞻性聲明是基於合理的假設,它無法保證其期望將能夠實現。由於公司成功以合理的條款或根本無法籌集足夠資本,手頭的可用現金以及可能影響我們支付未來股息能力的合同和法定限制以及諸多其他風險可能會因此導致實際結果與此處所述的結果有所不同,許多這些風險現在仍然是未知的且大體上超出公司的控制範圍,並且這些風險的詳細信息將隨時在公司向SEC提交的報告中披露,包括每季度提交的10-Q表,8-k表和每年提交的10-k表。BioVie Inc.不承擔更新此處所含的任何聲明(包括任何前瞻性聲明)的義務,除非法律另有規定。
For Investor Relations Inquiries:
投資者關係查詢:
Contact:
Bruce Mackle
Managing Director
LifeSci Advisors, LLC
bmackle@lifesciadvisors.com
聯繫方式:
Bruce Mackle
董事總經理
LifeSci Advisors,LLC
bmackle@lifesciadvisors.com
For Media Inquires
Melyssa Weible
Managing Partner, Elixir Health Public Relations
Ph: +1 201-723-5705
mweible@elixirhealthpr.com
媒體查詢請聯繫:Melyssa Weible,Elixir Health Public Relations負責人
電話:+1 201-723-5705
電子郵件:mweible@elixirhealthpr.com
電話:+1 201-723-5705
mweible@elixirhealthpr.com