During the first 16 weeks of the Extension phase of the RewinD-LB clinical study neflamapimod slowed clinical progression compared to controls, as assessed by Clinical Dementia Rating Sum of Boxes (CDR-SB) and Clinical Global Impression of Change (CGIC)

在RewinD-LB临床研究的扩展阶段的前16周内，与对照组相比，neflamapimod减缓了临床进展，这是通过临床痴呆评定量表总分（CDR-SB）和临床全局印象变化量表（CGIC）评估得出的。

Neflamapimod was associated with a reduced incidence of falls in the Extension phase of the study and new data to be presented at AD/PD™ 2025

Neflamapimod 在研究的延长期阶段显示出跌倒发生率降低，并且新的数据将在 2025 年的 AD/PD™ 会议上展示。

demonstrates

演示

improvements on endpoints measuring cognitive fluctuations and working memory

在测量认知波动和工作记忆的终点指标上的改进

The results demonstrate proof-of-concept for neflamapimod as a treatment for dementia with Lewy bodies (DLB)

这些结果证明了neflamapimod作为路易体痴呆（DLB）治疗的概念验证。

BOSTON, April 02, 2025 (GLOBE NEWSWIRE) -- CervoMed Inc. (NASDAQ: CRVO), a clinical stage company focused on developing treatments for age-related neurologic disorders (CervoMed or the Company), today announced that investigators plan to present results, including new results, from the Extension phase of the Phase 2b RewinD-LB study that show neflamapimod demonstrated a clinically meaningful effect on slowing clinical progression in patients with DLB in an oral presentation during the 19.

波士顿，2025年4月2日（环球新闻社）——CervoMed公司（纳斯达克股票代码：CRVO），一家专注于开发治疗与年龄相关的神经系统疾病疗法的临床阶段公司，今天宣布研究人员计划在第19届会议上以口头报告的形式展示2b期RewinD-LB研究扩展阶段的结果，包括新的结果，这些结果显示neflamapimod在减缓DLB患者的临床进展方面表现出具有临床意义的效果。

th

第

International Conference on Alzheimer’s and Parkinson’s Disease and Related Neurologic Disorders (AP/PD™) on Saturday, April 5, 2025.

2025年4月5日，星期六，举行阿尔茨海默病和帕金森病及相关神经系统疾病国际会议（AP/PD™）。

“The RewinD-LB Extension phase results for neflamapimod are highly encouraging. We are seeing a clear and meaningful effect on clinical worsening over time in patients with DLB, as assessed by CDR-SB and CGIC, which is further supported by positive data across several additional clinical endpoints,” stated Stephen Gomperts, MD, PhD, Associate Professor of Neurology at Harvard Medical School, Director, Lewy Body Dementia Unit at the Massachusetts General Hospital and site Principal Investigator for the RewinD-LB study.

“Neflamapimod的RewinD-LB扩展阶段结果非常令人鼓舞。我们在DLB患者中观察到随着时间推移，临床恶化情况有明确且有意义的改善，这通过CDR-SB和CGIC评估得出，并且还得到了多个其他临床终点的积极数据支持，”哈佛医学院神经病学副教授、麻萨诸塞州总医院路易体痴呆科主任、RewinD-LB研究站点主要研究员Stephen Gomperts医学博士表示。

“Importantly, these results validate and replicate prior clinical trial results and are consistent with the scientific hypothesis that neflamapimod can provide clinical benefit by arresting the loss of cholinergic neuron function in the basal forebrain.”.

“重要的是，这些结果验证并复制了先前的临床试验结果，并且与以下科学假设一致：neflamapimod可以通过阻止基底前脑中胆碱能神经元功能的丧失来提供临床益处。”

“The presentation of the Extension phase data at AD/PD™ 2025 is an opportunity to share our findings and engage deeply with the DLB medical community as we plan for pivotal development and work to bring neflamapimod to patients as rapidly as possible,” said John Alam, MD, Co-Principal Investigator of the RewinD-LB study and CEO of CervoMed.

“在2025年阿尔茨海默病和帕金森病国际会议（AD/PD™ 2025）上展示扩展阶段的数据，是我们分享研究成果并与DLB医学界深入交流的机会，同时我们正在规划关键性开发，并努力尽快将neflamapimod带给患者，”RewinD-LB研究的共同首席研究员兼CervoMed首席执行官John Alam博士说道。

“The positive findings across the primary outcome measure and multiple additional clinically important endpoints evaluated in the first 16 weeks of the Extension phase strengthen our belief that neflamapimod has the potential to be a transformative therapy for patients with DLB.”.

“在扩展阶段的前16周内，针对主要结局指标和多个其他具有临床意义的终点的积极发现，进一步增强了我们对neflamapimod有望成为DLB患者变革性疗法的信心。”

16-Week Results from the Extension Phase of the Phase 2b RewinD-LB Study

第2b期RewinD-LB研究扩展阶段的16周结果

1

1

Overview

概述

Of the 159 participants randomized in the initial 16-week double-blind, placebo-controlled phase (Initial phase) of the study, 152 completed the Initial phase and 149 entered the extension phase (Extension

在研究的初始16周双盲、安慰剂对照阶段（初始阶段）中，159名参与者被随机分配，其中152名完成了初始阶段，149名进入了延长期阶段（延长期）。

phase), during which all participants received neflamapimod. As previously announced, during the Extension phase, 55 participants continued to receive the same batch of capsules (Old Capsules) utilized in the Initial phase of the study, while 94 participants received a new batch of capsules (New Capsules) for at least 8 weeks during the Extension phase, approximately half of which received only the New Capsules.

阶段），在此期间所有参与者都接受了neflamapimod。如之前宣布的，在延长期阶段，55名参与者继续接受研究初始阶段使用的同一批胶囊（旧胶囊），而94名参与者在延长期阶段至少8周内接受了新一批胶囊（新胶囊），其中约一半仅接受了新胶囊。

In the Initial phase of the study, there were no discernible differences in clinical outcome between the neflamapimod (administered in Old Capsules) and placebo, which was hypothesized to be the result of sub-therapeutic plasma drug concentrations observed with the Old Capsules..

在研究的初始阶段，奈非马匹莫德（使用旧胶囊给药）和安慰剂在临床结果上没有明显的差异，这被认为是由旧胶囊导致的血浆药物浓度低于治疗水平的结果。

The New Capsules achieved target plasma drug concentrations, which has allowed CervoMed and clinical investigators to compare clinical outcomes between participants receiving the New Capsules (representing an active drug arm) and the Old Capsules (representing a control arm), as well as analyses that compared New Capsules administered during the Extension phase to placebo during the Initial phase of the study.

新胶囊达到了目标血浆药物浓度，这使得CervoMed和临床研究人员能够比较接受新胶囊（代表活性药物组）和旧胶囊（代表对照组）的参与者之间的临床结果，以及在扩展阶段施用的新胶囊与研究初始阶段的安慰剂进行比较的分析。

For the comparison to placebo, the Old Capsules served as an important negative control. Participants and site personnel were blinded as to whether New or Old Capsules were being dispensed during the first 16 weeks of the Extension..

对于与安慰剂的比较，旧胶囊作为重要的阴性对照。在扩展期的前16周内，参与者和现场工作人员并不知道分发的是新胶囊还是旧胶囊。

Positive effects seen with the New Capsules of neflamapimod compared to controls on multiple clinical endpoints:

与对照组相比，新胶囊形式的Neflamapimod在多个临床终点上显示出积极效果：

Improvement on primary outcome measures, change in CDR-SB, with the New Capsules both vs. Old Capsules (p<0.001) during first 16 weeks of the Extension phase and vs. placebo (p=0.003) utilizing all data in the study through to week 32 (includes Initial phase and first 16 weeks of the Extension phase)..

在延长期的前16周内，新胶囊相较于旧胶囊（p<0.001）以及相较于安慰剂（p=0.003）在主要结局指标CDR-SB的变化上表现出改善，利用研究中直至第32周的所有数据（包括初始阶段和延长期的前16周）。

1

1

The magnitude of the effect on the CDR-SB was for all participants a mean improvement of 0.73 points with the New Capsules compared to the Old Capsules, and a mean 0.81 points in participants whose screening plasma ptau181 was less than 2.2 pg/mL (indicating absence of Alzheimer’s disease (AD) co-pathology); both exceeding the 0.5-point treatment group difference considered to be clinically meaningful (Tarawneh and Pankratz, .

新胶囊相较于旧胶囊，对所有参与者在 CDR-SB 上的效果平均提高了 0.73 分，而在筛选时血浆 ptau181 水平低于 2.2 pg/mL 的参与者（表明没有阿尔茨海默病 (AD) 共病病理）中平均提高了 0.81 分；两者均超过了被认为具有临床意义的 0.5 分治疗组差异（Tarawneh 和 Pankratz，）。

Alzheimers Res Ther

阿尔茨海默病研究与治疗

2024;16:3).

2024年；16:3）。

The percentage of participants who had clinically meaningfully worsening (i.e. increased greater than or equal to 1.5 points on the CDR-SB) during the first 16 weeks of the Extension phase was 40% lower on a relative basis (26.8% vs. 45.1%) in New Capsule recipients compared to Old Capsule recipients; and 62% lower (17.7% vs.

在扩展阶段的前16周内，新胶囊受试者中在临床上有意义恶化（即CDR-SB评分增加大于或等于1.5分）的比例相对降低了40%（26.8% vs. 45.1%），而与旧胶囊受试者相比，这一比例降低了62%（17.7% vs.

45.8%) in participants whose screening plasma ptau181 was less than 2.2 pg/mL..

45.8%)，其筛查血浆 ptau181 小于 2.2 pg/mL 的参与者中。

Improvement on Alzheimer’s Disease Cooperative Study (ADCS)-CGIC in participants administered New Capsules both in comparison to Old Capsules (p=0.035) during the Extension phase and in a within-participant comparison to placebo treatment during the Initial phase (p=0.039). The improvement compared to placebo in the within-participant analysis was not seen with the Old Capsules..

在延长期中，与旧胶囊相比，新胶囊在阿尔茨海默病合作研究（ADCS）-CGIC上表现出改善（p=0.035）；在初始期中，与安慰剂治疗相比，新胶囊在同一参与者内分析中也显示出改善（p=0.039）。而在同一参与者分析中，与安慰剂相比的改善并未在旧胶囊中观察到。

Based on evaluation of 95% confidence intervals, improvement with New Capsules

基于对 95% 置信区间的评估，新胶囊有所改进

versus

对比

Old Capsules seen on Dementia Cognitive Fluctuation Scale and International Shopping List Test-Recognition (measuring working memory); and positive trends were seen on 12-item Neuropsychiatric Inventory (NPI-12), Timed Up and Go (TUG) and Unified Parkinson’s Disease Rating Scale Part III (Motor). These new analyses support the positive findings previously reported for the CDR-SB and the ADCS-CGIC..

在痴呆认知波动量表和国际购物清单测试-识别（测量工作记忆）中观察到旧胶囊的影响；在12项神经精神量表（NPI-12）、计时起立行走测试（TUG）和统一帕金森病评定量表第三部分（运动）中也显示出积极趋势。这些新的分析结果支持了之前报告的CDR-SB和ADCS-CGIC的积极发现。

Old and New Capsules have similar overall safety and tolerability profile:

新旧胶囊的总体安全性和耐受性特征相似：

Both Old and New Capsules demonstrated comparable tolerability profiles and no new safety signals were identified during the Extension phase.

新旧胶囊均显示出相似的耐受性特征，在延长期未发现新的安全信号。

Lower incidence of falls with the New Capsules (4% vs.15.2% with Old Capsules during the Extension phase, p=0.025, and 19.7% with placebo in the Initial phase, p=0.007) in participants with screening ptau181 < 2.2 pg/mL.

在筛查 ptau181 < 2.2 pg/mL 的参与者中，新胶囊的跌倒发生率较低（在延长期，新胶囊为 4%，旧胶囊为 15.2%，p=0.025；在初始期，安慰剂为 19.7%，p=0.007）。

About the RewinD-LB Phase 2b Study in Dementia with Lewy Bodies and Next Steps

关于路易体痴呆的RewinD-LB第二b阶段研究及后续步骤

The RewinD-LB clinical study is a randomized, 16-week, double-blind, placebo-controlled clinical study evaluating oral neflamapimod (40mg TID), with a 32-week neflamapimod only treatment Extension phase, in 159 patients with DLB. Patients with AD co-pathology, as assessed by plasma ptau181 levels, were excluded from the study.

RewinD-LB 临床研究是一项随机、16 周、双盲、安慰剂对照的临床试验，评估口服 neflamapimod（40mg TID）在 159 名 DLB 患者中的效果，并包含一个 32 周仅使用 neflamapimod 的扩展治疗阶段。通过血浆 ptau181 水平评估，伴有 AD 共病的患者被排除在研究之外。

Compared to patients with “pure” DLB – who may comprise up to 50% of the total diagnosed DLB patient population at any given time – DLB patients with AD co-pathology have significant, irreversible neuronal loss in the hippocampus that limits response to treatment. The primary outcome measure in the study is change in the CDR-SB, and secondary endpoints include Alzheimer's Disease Cooperative Study - CGIC, the TUG test, and a cognitive test battery.

与“纯”DLB患者（在任何给定时间可能占总诊断为DLB患者群体的50%）相比，具有AD共病病理的DLB患者海马体存在显著且不可逆的神经元损失，这限制了治疗的反应。研究的主要结局指标是CDR-SB的变化，次要终点包括阿尔茨海默病合作研究-CGIC、TUG测试和认知测试组合。

The RewinD-LB study is funded primarily by a $21.3 million grant from the National Institutes of Health’s National Institute on Aging, which is expected to be disbursed over the course of the study as costs are incurred. The study includes 43 sites across in the United States, the United Kingdom, and the Netherlands).

RewinD-LB 研究主要由美国国立卫生研究院下属的国家老龄化研究所提供的 2130 万美元资助，预计将在研究过程中根据费用支出逐步发放。该研究涵盖美国、英国和荷兰的 43 个地点。

Participants completing the 16-week Initial phase of the study were able to continue in the study while receiving neflamapimod treatment for an additional 32-week Extension phase, within which the same efficacy assessments were conducted during the first 16 weeks as were obtained during the Initial phase..

完成为期16周的初始阶段研究的参与者能够继续参与研究，并在额外的32周延长期中接受neflamapimod治疗，期间在前16周进行与初始阶段相同的疗效评估。

CervoMed expects to complete the full 32-weeks of the Extension phase of the RewinD-LB study and engage with regulatory authorities to discuss finalizing Phase 3 plans for neflamapimod after these additional data become available later in 2025.

CervoMed 预计将完成 RewinD-LB 研究扩展阶段的全部 32 周，并在 2025 年晚些时候这些额外数据出炉后，与监管机构讨论 neflamapimod 的第三阶段最终计划。

About CervoMed

关于CervoMed

CervoMed is a clinical-stage company focused on developing treatments for age-related neurologic disorders. The Company is currently developing neflamapimod, an investigational, orally administered small molecule brain penetrant that inhibits p38 mitogen-activated protein kinase alpha. Neflamapimod has the potential to treat synaptic dysfunction, the reversible aspect of the underlying neurodegenerative processes that causes clinical disease expression in DLB and certain other major neurological disorders.

CervoMed是一家临床阶段的公司，专注于开发治疗与年龄相关的神经系统疾病的方法。该公司目前正在开发neflamapimod，一种研究性、口服的小分子脑渗透剂，可抑制p38丝裂原活化蛋白激酶α。Neflamapimod有潜力治疗突触功能障碍，这是导致DLB及其他某些主要神经系统疾病临床表现的潜在神经退行性过程中的可逆部分。

Neflamapimod is currently being evaluated in a Phase 2b study in patients with DLB..

Neflamapimod目前正在一项针对DLB患者的2b期研究中进行评估。

Forward-Looking Statements

前瞻性声明

This press release includes express and implied forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, regarding the intentions, plans, beliefs, expectations or forecasts for the future of the Company, including, but not limited to, the Company’s financial position and cash runway, the therapeutic potential of neflamapimod, the anticipated timing and achievement of clinical and development milestones, including the completion the RewinD-LB Phase 2b clinical study and the Company’s announcement of additional data therefrom, any other expected or implied benefits or results, including that any initial clinical results observed with respect to neflamapimod in the AscenD-LB study or RewinD-LB study will be replicated in later trials, and the timing of the initiation of any potential future trials or interactions with regulatory authorities, including the Company’s need to acquire sufficient funding for any Phase 3 trial of neflamapimod in DLB.

本新闻稿包含根据经修订的1995年《私人证券诉讼改革法案》所定义的明示和暗示前瞻性陈述，涉及公司未来的意图、计划、信念、预期或预测，包括但不限于公司的财务状况和现金跑道、neflamapimod的治疗潜力、预期的临床和开发里程碑的时间及达成情况（包括完成RewinD-LB二期b临床研究及公司宣布相关额外数据）、任何其他预期或暗示的利益或结果（包括在AscenD-LB研究或RewinD-LB研究中观察到的有关neflamapimod的任何初步临床结果将在后续试验中得到复制），以及任何潜在未来试验或与监管机构互动的启动时间（包括公司为neflamapimod在DLB领域的任何三期试验获取足够资金的需求）。

Terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “aims,” “seeks,” “intends,” “may,” “might,” “could,” “might,” “will,” “should,” “approximately,” “potential,” “target,” “project,” “contemplate,” “predict,” “forecast,” “continue,” or other words that convey uncertainty of future events or outcomes (including the negative of these terms) may identify these forward-looking statements.

诸如“相信”、“估计”、“预期”、“计划”、“目标”、“寻求”、“意图”、“可能”、“也许”、“能够”、“将会”、“应该”、“大约”、“潜在”、“针对”、“项目”、“考虑”、“预测”、“展望”、“继续”等词语，或传达未来事件或结果不确定性的其他词语（包括这些词语的否定形式），可能用于识别这些前瞻性陈述。

Although there is believed to be reasonable basis for each forward-looking statement contained herein, forward-looking statements by their nature involve risks and uncertainties, known and unknown, many of which are beyond the Company’s control and, as a result, actual results could differ materially from those expressed or implied in any forward-looking statement.

虽然相信本文所含的每项前瞻性陈述均有合理的依据，但前瞻性陈述本身涉及已知和未知的风险与不确定性，其中许多是公司无法控制的，因此，实际结果可能与任何前瞻性陈述中明示或暗示的结果有重大差异。

Particul.

颗粒。

Contacts:

联系人：

Investors

投资者

PJ Kelleher

PJ Kelleher

LifeSci Advisors

生命科学顾问

Investors@cervomed.com

投资者@cervomed.com

617-430-7579

617-430-7579

Media

媒体

Argot Partners

黑话伙伴

cervomed@argotpartners.com

cervomed@argotpartners.com

212-600-1902

212-600-1902

1

1

Though all analyses reported are exploratory in nature, along with 95% confidence intervals which are reported for all endpoints, p-values are reported for the CDR-SB and CGIC to provide a measure of the probability that any differences identified between the treatment groups are due to chance.

尽管所有报告的分析都具有探索性，但所有终点均报告了95%置信区间，并且CDR-SB和CGIC报告了p值，以提供一种衡量概率的指标，即治疗组之间发现的任何差异是由于偶然因素造成的可能性。