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An Independent Data and Safety Monitoring Board (DSMB) Recently Evaluated the Interim Patient Safety Database for Oral Simufilam in On-going Phase 3 Trials.

一个独立的数据和安全监测委员会（DSMB）最近在正在进行的3期临床试验中评估了口服西mufilam的临时患者安全数据库。

The DSMB Recommended Both Phase 3 Trials Continue as Planned, Without Modification.

DSMB建议两项3期试验均按计划继续进行，无需修改。

Final Clinical Safety Data for Simufilam Are Expected at the Conclusion of the Phase 3 Program.

预计在第三阶段计划结束时，西莫菲兰的最终临床安全性数据。

AUSTIN, Texas, Sept. 24, 2024 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a biotechnology company focused on Alzheimer’s disease, today announced the completion of a third interim safety review of simufilam in on-going Phase 3 clinical trials in patients with Alzheimer’s disease. A routine, scheduled meeting of a Data and Safety Monitoring Board (DSMB) resulted in a recommendation that both of Cassava Sciences’ on-going Phase 3 studies continue as planned, without modification..

2024年9月24日，德克萨斯州奥斯汀（环球通讯社）--专注于阿尔茨海默病的生物技术公司木薯科学公司（Nasdaq:SAVA）今天宣布，在阿尔茨海默病患者正在进行的第三阶段临床试验中，完成了西莫非仑的第三次中期安全性审查。数据和安全监测委员会（DSMB）的例行会议产生了一项建议，即木薯科学正在进行的第三阶段研究均按计划继续进行，不进行任何修改。。

“We are pleased to have satisfactorily completed this safety review, the last before the expected top-line read out for our first Phase 3 study.” said Jim Kupiec, Chief Medical Officer. “We look forward to announcing top-line efficacy, safety and biomarker data for our 12-month Phase 3 study before the end of 2024.”.

首席医疗官吉姆·库皮埃克（JimKupiec）说：“我们很高兴圆满完成了这项安全审查，这是我们第一阶段3研究预期的顶线之前的最后一次。”。“我们期待在2024年底之前公布我们为期12个月的3期研究的一线疗效，安全性和生物标志物数据。”。

The DSMB is composed of independent clinical research experts who periodically review interim patient safety data for Cassava Sciences’ on-going Phase 3 trials of simufilam in Alzheimer’s disease. This DSMB only reviews patient safety. It does not assess drug efficacy.

。本DSMB仅审查患者安全。它不评估药物疗效。

On-going Phase 3 Studies with Simufilam

正在与Simufilam进行第三阶段研究

Cassava Sciences’ simufilam is a novel, small molecule drug candidate for the proposed treatment of Alzheimer’s disease dementia. The drug is in late-stage clinical evaluation in a pair of pivotal Phase 3 trials. These Phase 3 trials are fully enrolled. Over 1,900 patients with mild-to-moderate Alzheimer’s disease who also met other study eligibility criteria were randomized into the trials..

木薯科学公司的simufilam是一种新型的小分子候选药物，用于治疗阿尔茨海默病痴呆症。在一对关键的3期临床试验中，该药物处于晚期临床评估阶段。这些3期试验已全部登记。1900多名轻度至中度阿尔茨海默病患者也符合其他研究资格标准，被随机分配到试验中。。

The first Phase 3 trial (NCT04994483) has a 52-week treatment period; 804 Alzheimer’s patients were randomized into this trial. Top-line results for the 52-week Phase 3 trial are currently expected by year-end 2024.

第一阶段3试验（NCT04994483）的治疗期为52周；804名阿尔茨海默病患者被随机分配到这项试验中。目前，预计到2024年底，为期52周的第三阶段试验的最终结果。

The second Phase 3 trial (NCT05026177) has a 76-week treatment period; 1,125 Alzheimer’s patients were randomized into this trial. Top-line results for the 76-week Phase 3 trial are currently expected approximately mid-year 2025.

第二阶段3试验（NCT05026177）的治疗期为76周；1125名阿尔茨海默病患者被随机分配到这项试验中。目前预计，为期76周的第三阶段试验的最终结果将在2025年年中左右。

Patients with mild-to-moderate Alzheimer’s disease dementia who met study eligibility criteria were recruited into the Phase 3 program from clinical sites in the U.S., Puerto Rico, Canada, Australia and South Korea. Cassava Sciences is conducting its on-going Phase 3 program in collaboration with Premier Research International, a global contract research organization (CRO)..

。木薯科学正在与全球合同研究组织（CRO）Premier Research International合作进行其正在进行的第三阶段计划。。

Today’s news follows interim safety MRI data announced in October 2023, which suggests simufilam is not associated with treatment-emergent amyloid-related imaging abnormalities (ARIA). In addition, September 2023 and March 2024 meetings of the DSMB recommended that both Phase 3 trials continue as planned, without modification.

今天的新闻是在2023年10月宣布的临时安全性MRI数据之后发布的，该数据表明西穆菲兰与治疗出现的淀粉样蛋白相关成像异常（ARIA）无关。此外，2023年9月和2024年3月的DSMB会议建议，这两个3期试验均按计划继续进行，不做任何修改。

Final safety data are expected at the conclusion of the Phase 3 program..

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About Cassava Sciences, Inc.

关于木薯科学公司。

Cassava Sciences is a clinical-stage biotechnology company based in Austin, Texas. Our mission is to detect and treat neurodegenerative diseases, such as Alzheimer’s disease.

木薯科学是一家临床阶段生物技术公司，总部位于德克萨斯州奥斯汀。我们的任务是检测和治疗神经退行性疾病，如阿尔茨海默病。

Simufilam is Cassava Sciences’ small molecule oral drug candidate currently in Phase 3 clinical trials for the treatment of Alzheimer's disease. Simufilam targets a specific site on filamin A, a scaffolding protein that is critical to certain receptor interactions in the brain. Cassava Sciences believes that simufilam interrupts amyloid-β42 binding to receptors in the brain and may affect the Alzheimer's disease process.

Simufilam是木薯科学公司的小分子口服候选药物，目前正在进行治疗阿尔茨海默病的3期临床试验。Simufilam靶向filamin a上的特定位点，filamin a是一种支架蛋白，对大脑中的某些受体相互作用至关重要。木薯科学认为，西木菲兰会中断淀粉样蛋白-β42与大脑受体的结合，并可能影响阿尔茨海默氏病的进程。

Cassava Sciences owns exclusive, worldwide rights to its investigational product candidates and related technologies, without royalty obligations to any third party..

木薯科学拥有其候选研究产品和相关技术的全球独家权利，不向任何第三方承担版税义务。。

For more information, please visit: https://www.CassavaSciences.com

For more information, please visit: https://www.CassavaSciences.com

For More Information Contact: Eric Schoen, Chief Financial Officer(512) 501-2450ESchoen@CassavaSciences.com

欲了解更多信息，请联系：首席财务官Eric Schoen（512）501-2450ESchoen@CassavaSciences.com

Cautionary Note Regarding Forward-Looking Statements and Other Notices: This news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “anticipate,” “believe,” “could,” “expect,” “forecast,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” and other words and terms of similar meaning.

关于前瞻性声明和其他通知的注意事项：本新闻稿包含前瞻性声明，包括根据1995年《私人证券诉讼改革法》的安全港条款所作的声明。这些陈述可以用“预期”、“相信”、“可能”、“预期”、“预测”、“打算”、“可能”、“计划”、“可能”、“潜在”、“将”等词语以及其他含义类似的词语来识别。

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Such statements are based largely on our current expectations and projections about future events. Such statements speak only as of the date of this news release and are subject to a number of risks, uncertainties and assumptions, including, but not limited to, those risks relating to the ability to conduct, complete or announce top-line results of our clinical studies, including efficacy, safety and biomarker data, on expected timelines; the ability to demonstrate the specificity, safety, efficacy or potential health benefits of our product candidates in people with Alzheimer’s disease dementia; the interim safety status or profile of simufilam to date in our Phase 3 clinical studies; our current expectations regarding timing of clinical data for our Phase 3 studies; any expected clinical results of Phase 3 studies; the treatment of people with Alzheimer’s disease dementia; verbal comments made by our employees regarding simufilam, safety, drug effects, and the treatment of Alzheimer’s disease with simufilam; potential benefits, if any, of our product candidates and including those described in the section entitled “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023 and Quarterly Report on Form 10-Q for the period ended June 30, 2024, and future reports to be filed with the SEC.

这些声明主要基于我们目前对未来事件的期望和预测。此类声明仅在本新闻发布之日发表，并受到许多风险，不确定性和假设的影响，包括但不限于与在预期时间表内进行，完成或宣布我们临床研究的一线结果（包括疗效，安全性和生物标志物数据）相关的风险；能够证明我们的候选产品对阿尔茨海默病痴呆患者的特异性，安全性，有效性或潜在的健康益处；迄今为止，在我们的3期临床研究中，西穆菲兰的临时安全状态或概况；我们目前对3期研究临床数据时间的期望；3期研究的任何预期临床结果；阿尔茨海默病痴呆患者的治疗；我们的员工对西莫非仑，安全性，药物作用以及用西莫非仑治疗阿尔茨海默病的口头评论；我们的候选产品的潜在利益（如有），包括截至2023年12月31日的10-K表年度报告中题为“风险因素”的部分所述的利益，以及截至2024年6月30日的10-Q表季度报告中所述的利益，以及未来提交给SEC的报告。

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The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from expectations in any forward-looking statement. In light of these risks, uncertainties and assumptions, the forward-looking statements and events discussed in this news release are inherently uncertain and may not occur, and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements.

上述列出了许多（但不是全部）因素，这些因素可能导致实际结果与任何前瞻性声明中的预期不同。鉴于这些风险、不确定性和假设，本新闻稿中讨论的前瞻性声明和事件本质上是不确定的，可能不会发生，实际结果可能与前瞻性声明中预期或暗示的结果存在重大不利差异。

Accordingly, you should not rely upon forward-looking statements as predictions of future events. Except as required by law, we disclaim any intention or responsibility for updating or revising any forward-looking statements contained in this news release. For further information regarding these and other risks related to our business, investors should consult our filings with the SEC, which are available on the SEC's website at www.sec.gov..

因此，您不应将前瞻性陈述视为对未来事件的预测。除法律要求外，我们不打算或不负责更新或修改本新闻稿中包含的任何前瞻性声明。有关这些风险和与我们业务相关的其他风险的更多信息，投资者应咨询我们向SEC提交的文件，这些文件可在SEC网站www.SEC.gov上查阅。。

All our pharmaceutical assets under development are all investigational product candidates. These have not been approved for use in any medical indication by any regulatory authority in any jurisdiction and their safety, efficacy or other desirable attributes, if any, have not been established in any patient population.

我们正在开发的所有制药资产都是候选研究产品。这些药物尚未被任何司法管辖区的任何监管机构批准用于任何医疗适应症，其安全性，有效性或其他理想属性（如果有的话）尚未在任何患者群体中建立。

Consequently, none of our product candidates are approved or available for sale anywhere in the world, and you should not assume that they may ever be approved or available for sale at any time..

因此，我们的候选产品均未在世界任何地方获得批准或可供销售，您不应认为它们可能会在任何时候获得批准或可供销售。。

Our clinical results from earlier-stage clinical trials may not be indicative of future results from later-stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements or any scientific data we present or publish.

我们早期临床试验的临床结果可能无法表明后期或大规模临床试验的未来结果，也无法确保监管部门的批准。您不应过度依赖这些声明或我们提供或发布的任何科学数据。

We are in the business of new drug discovery and development. Our research and development activities are long, complex, costly and involve a high degree of risk. Holders of our common stock should carefully read our current Annual Report on Form 10-K and Quarterly Reports on Form 10-Q in their entirety, including the risk factors therein.

我们从事新药发现和开发业务。。我们的普通股持有人应仔细阅读我们目前的10-K表年度报告和10-Q表季度报告的全部内容，包括其中的风险因素。

Because risk is fundamental to the process of drug discovery and development, you are cautioned to not invest in our publicly traded securities unless you are prepared to sustain a total loss of the money you have invested..

由于风险是药物发现和开发过程的基础，因此提醒您不要投资我们的公开交易证券，除非您准备承受所投资资金的全部损失。。

Source: Cassava Sciences, Inc.

资料来源：木薯科学公司。