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安捷诺宣布在2025年PNS会议上展示Tanruprubart作为首个潜在的针对格林-巴利综合征(GBS)的靶向疗法的临床进展

Annexon Announces Presentations on the Clinical Advancement of Tanruprubart as the First Potential Targeted Therapy for Guillainarré Syndrome (GBS) at the 2025 PNS Meeting

ANNEXON 等信源发布 2025-05-09 17:00

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First Oral Presentation by the International Guillain-Barré Syndrome Outcomes Study (IGOS) of the Real-World Evidence (RWE) Results Showing Improved Outcomes with Tanruprubart (formerly ANX005) Compared to Current Standards of Care in Matched Patient Populations

国际吉兰-巴雷综合征结局研究 (IGOS) 的首次口头报告,展示了真实世界证据 (RWE) 结果,表明与当前匹配患者群体的护理标准相比,Tanruprubart(前称 ANX005)改善了治疗效果。

New Analyses of Phase 3 Trial Highlight Tanruprubart’s Early and Durable Treatment Effect and Improvement in Quality of Life in Patients with GBS

第三项三期试验的新分析强调了Tanruprubart在GBS患者中的早期和持久治疗效果及生活质量的改善

BRISBANE, Calif., May 09, 2025 (GLOBE NEWSWIRE) --

加利福尼亚州布里斯班,2025年5月9日(环球新闻社)--

Annexon, Inc.

安尼逊公司

(Nasdaq: ANNX), a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye, today announced oral and poster presentations highlighting improved outcomes with tanruprubart (formerly ANX005) at the 2025 Peripheral Nerve Society (PNS) Annual Meeting at the Edinburgh International Conference Centre being held May 17-20, 2025 in Edinburgh, UK..

(纳斯达克:ANNX),一家致力于为患有严重经典补体介导的神经炎症疾病(涉及身体、大脑和眼睛)的患者开发新型疗法的晚期临床平台的生物制药公司,今天宣布在2025年5月17日至20日在英国爱丁堡举行的2025年周围神经学会(PNS)年会上,通过口头报告和海报展示了tanruprubart(前称ANX005)改善疗效的相关数据,会议地点为爱丁堡国际会议中心。

GBS is a neuromuscular emergency and rare autoimmune disease with no FDA-approved therapies that is characterized by rapidly progressing and severe weakness that can lead to complete paralysis, often requiring intensive care and mechanical ventilation. Tanruprubart is a first-in-kind monoclonal antibody designed to block C1q, the initiating molecule of the classical complement cascade, with a single infusion to halt ongoing neuroinflammation and nerve damage in the acute phase of GBS to improve and expedite overall recovery..

GBS是一种神经肌肉急症和罕见的自身免疫疾病,目前尚无FDA批准的疗法,其特征是迅速进展且严重的虚弱,可能导致完全瘫痪,通常需要重症监护和机械通气。Tanruprubart是一种首创的单克隆抗体,旨在通过单次输注阻断经典补体级联反应的起始分子C1q,以阻止GBS急性期持续的神经炎症和神经损伤,从而改善并加速整体康复。

Oral Presentation

口头报告

“Comparative Effectiveness in IGOS: ANX005 Versus Intravenous Immunoglobulin or Plasma Exchange for Guillain-Barré Syndrome”

“IGOS中的比较有效性:ANX005与静脉注射免疫球蛋白或血浆置换治疗吉兰-巴雷综合征”

IGOS Presenter: Eveline Wiegers, M.D., Ph.D.

IGOS 主讲人:Eveline Wiegers,医学博士,哲学博士。

Date/Time: Monday, May 19, from 3:55 pm to 4:10 pm British Summer Time (BST)

日期/时间:星期一,5月19日,英国夏令时间(BST)下午3点55分至4点10分

Poster Presentations

海报展示

“Linking Early Complement Inhibition to Long-Term Outcomes in GBS: Objective Measures Support Tanruprubart (ANX005) Efficacy”

“将早期补体抑制与GBS的长期结果联系起来:客观指标支持Tanruprubart(ANX005)的疗效”

Presenter: Glenn Morrison, Ph.D.

主持人:格伦·莫里森,博士

Date/Time: Sunday May 18, from 2:30 pm to 3:20 pm BST

日期/时间:星期日,5月18日,英国夏令时间下午2点30分至3点20分

“Tanruprubart (ANX005) Improves Health-related Quality of Life in Patients with Guillain-Barré Syndrome Compared to Placebo”

“Tanruprubart (ANX005) 相较于安慰剂改善了吉兰-巴雷综合征患者与健康相关的生活质量”

Presenter: Glenn Morrison, Ph.D.

主持人:格伦·莫里森,博士

Date/Time: Monday, May 19, from 2:10 pm to 3:10 pm BST. Poster also selected as a flash oral presentation from 5:30 pm to 5:35 pm BST.

日期/时间:5月19日星期一,英国夏令时间下午2:10至3:10。海报还被选为英国夏令时间下午5:30至5:35的快速口头报告。

“Efficacy of Tanruprubart (ANX005) for Treatment of Guillain-Barré Syndrome in a Broad Spectrum of Patients”

“Tanruprubart(ANX005)治疗广泛类型吉兰-巴雷综合征患者的疗效”

Presenter: Henk-André Kroon, M.D.

主持人:Henk-André Kroon,医学博士

Date/Time: Monday May 19, from 2:10 pm to 3:10 pm BST

日期/时间:5月19日星期一,英国夏令时间下午2点10分至3点10分

About Tanruprubart (formerly ANX005)

关于Tanruprubart(前称ANX005)

Annexon’s lead investigational therapy, tanruprubart, is a first-of-its kind selective, targeted and rapid-acting agent designed to reduce inflammation and nerve damage by stopping C1q activity in the peripheral and central nervous systems. In GBS, tanruprubart is designed to seek out C1q and prevent its binding to targets on peripheral nerves.

Annexion公司的主要研究性疗法tanruprubart是一种首创的选择性、靶向性和速效剂,旨在通过抑制外周和中枢神经系统中的C1q活性来减轻炎症和神经损伤。在GBS中,tanruprubart旨在寻找C1q并阻止其与外周神经上的靶标结合。

Tanruprubart is administered intravenously and has been observed to act almost immediately in blocking C1q function. The aim of an effective treatment in GBS is to rapidly stop the autoimmune damage on nerve cells, allowing patients to regain muscle strength sooner and to regain independence and return to pre-illness activities.

坦鲁普鲁巴特通过静脉注射给药,已被观察到几乎立即起效,阻断C1q功能。在吉兰-巴雷综合征(GBS)中,有效治疗的目标是迅速阻止对神经细胞的自身免疫损伤,使患者更快恢复肌肉力量、重获独立性并回到患病前的活动状态。

Tanruprubart has received both Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration as well as orphan drug designation from the European Medicines Agency for the treatment of GBS..

Tanruprubart 已获得美国食品和药物管理局的快速通道和孤儿药资格认定,以及欧洲药品管理局授予的用于治疗 GBS 的孤儿药资格认定。

About Guillain-Barré Syndrome (GBS)

关于吉兰-巴雷综合征 (GBS)

GBS is a rare neuromuscular emergency resulting from an acute autoantibody and classical complement-mediated attack on peripheral nerves that generally occurs post-infection in otherwise healthy persons. It is an acute, rapidly progressive disease with a narrow timeframe for therapeutic intervention.

GBS 是一种罕见的神经肌肉急症,由急性自身抗体和经典补体介导的对外周神经的攻击引起,通常发生在其他方面健康的个体感染后。它是一种急性、快速进展的疾病,治疗干预的时间窗口很窄。

GBS results in the hospitalization of more than 22,000 people annually in the U.S. and Europe. The peripheral nerve damage progresses rapidly, causing acute neuromuscular paralysis that can lead to significant morbidity, disability and mortality. Currently, there are no approved treatments for GBS in the U.S.

GBS每年在美国和欧洲导致超过22,000人住院。周围神经损伤进展迅速,引发急性神经肌肉麻痹,可能导致严重的发病率、残疾甚至死亡。目前,美国尚无获批的GBS治疗方法。

The long-term disease burden associated with GBS has led to a multi-billion-dollar annual economic cost to the U.S. healthcare system alone. More information about the impact of GBS is available at .

与GBS相关的长期疾病负担仅在美国医疗系统中就造成了每年数十亿美元的经济成本。更多关于GBS影响的信息可在以下网址获取:。

MoveGBSForward.com

MoveGBSForward.com

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About Annexon

关于 Annexon

Annexon Biosciences (Nasdaq: ANNX) is developing therapeutics that stop classical complement-driven neuroinflammation as first-in-kind treatments for millions of people living with serious neuroinflammatory diseases of the body, brain and eye. Our novel scientific approach focuses on C1q, the initiating molecule of classical complement’s potent inflammatory pathway that when misdirected can lead to tissue damage and loss.

安尼逊生物科学公司(纳斯达克股票代码:ANNX)正在开发能够阻止经典补体驱动的神经炎症的治疗方法,作为针对数百万患有严重神经炎症疾病(涉及身体、大脑和眼睛)的患者的首创疗法。我们的新型科学方法专注于C1q,这是经典补体强效炎症通路的起始分子,当其误导向时可能导致组织损伤和丧失。

By targeting C1q, our immunotherapies are designed to stop this neuroinflammatory cascade in disease before it starts. Our pipeline spans three diverse therapeutic areas – autoimmune, neurodegenerative and ophthalmic diseases – and includes targeted investigational drug candidates designed to address the unmet needs of over 8 million people worldwide.

通过靶向C1q,我们的免疫疗法旨在阻止这种神经炎症级联反应在疾病发作前开始。我们的研发管线涵盖三个不同的治疗领域——自身免疫性疾病、神经退行性疾病和眼科疾病——并包括针对性的在研药物候选方案,旨在满足全球超过800万人尚未满足的需求。

Annexon’s mission is to deliver game-changing therapies to patients so that they can live their best lives. To learn more visit .

安尼逊的使命是为患者提供改变生活的疗法,让他们能够过上最好的生活。欲了解更多信息,请访问。

annexonbio.com

安内克森生物公司官网

.

Forward Looking Statements

前瞻性声明

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “suggest,” “target,” “on track,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology.

本新闻稿包含根据修订后的《1933年证券法》第27A条和修订后的《1934年证券交易法》第21E条所定义的前瞻性陈述。在某些情况下,您可以通过术语识别前瞻性陈述,例如“目标”、“预期”、“假设”、“相信”、“考虑”、“继续”、“可能”、“设计”、“由于”、“估计”、“期望”、“目的”、“意图”、“可能”、“目标”、“计划”、“定位”、“潜力”、“预测”、“寻求”、“应该”、“建议”、“针对”、“按计划进行”、“将”、“会”以及其他类似的表达,这些表达是对未来事件和未来趋势的预测或指示,或是这些术语的否定或其他类似术语。

All statements other than statements of historical facts contained in this press release are forward-looking statements. These forward-looking statements include, but are not limited to, the ability of tanruprubart (formerly ANX005) to stop C1q activity in the peripheral and central nervous systems; the clinical and regulatory status of ANX005; and the potential therapeutic benefit of ANX005; the potential benefits from treatment with anti-C1q therapy; and continuing advancement of the company’s portfolio.

本新闻稿中包含的所有陈述,除历史事实陈述外,均为前瞻性陈述。这些前瞻性陈述包括但不限于:tanruprubart(前称ANX005)在周围和中枢神经系统中阻止C1q活性的能力;ANX005的临床和监管状态;ANX005的潜在治疗益处;抗C1q疗法治疗的潜在益处;以及公司产品组合的持续推进。

Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: the company’s history of net operating losses; the company’s ability to obtain necessary capital to fund its clinical programs; the early stages of clinical development of the company’s product candidates; the effects of public health crises on the company’s clinical programs and business operations; the com.

前瞻性陈述并非对未来业绩的保证,并且受风险和不确定性的影响,可能导致实际结果和事件与预期有重大差异,包括但不限于以下相关风险和不确定性:公司净经营亏损的历史;公司获得必要资金以资助其临床项目的能力;公司产品候选者临床开发的早期阶段;公共卫生危机对公司临床项目和业务运营的影响;以及公司竞争环境。

Investor Contact:

投资者联系方式:

Joyce Allaire

乔伊斯·阿莱尔

LifeSci Advisors, LLC

生命科学顾问有限公司

jallaire@lifesciadvisors.com

杰拉尔@生命科学顾问.com

Media Contact:

媒体联系人:

Sheryl Seapy

谢丽尔·西皮

Real Chemistry

真实化学

949-903-4750

949-903-4750

sseapy@realchemistry.com

sseapy@realchemistry.com