CAMBRIDGE, Mass., May 7, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ('NeuroSense'), a company developing novel treatments for severe neurodegenerative diseases, announces new analyses from its Phase 2b PARADIGM clinical trial, demonstrated a statistically significant slowing of disease progression in high-risk ALS patients treated with PrimeC by 43% (p=0.02) as compared to placebo in the pre-specified per protocol (PP) population analysis after 6 months of treatment.

马萨诸塞州剑桥市，2024年5月7日/PRNewswire/--NeuroSense Therapeutics Ltd.（纳斯达克：NRSN）（“NeuroSense”）是一家开发严重神经退行性疾病新型治疗方法的公司，它宣布了其2b期PARADIGM临床试验的新分析，表明在治疗6个月后，与安慰剂相比，用PrimeC治疗的高危ALS患者的疾病进展在统计学上显着减慢了43%（p=0.02）。

The slowing of disease progression demonstrated by PrimeC versus placebo translates to a 5.04 points difference in the ALSFRS-R in favor of PrimeC (Confidence Interval: 0.862, 9.214; n=38)..

PrimeC与安慰剂相比，疾病进展的减缓意味着ALSFRS-R的差异为5.04点，有利于PrimeC（置信区间：0.862、9.214；n=38）。。

High-risk patients, defined by the European Network for the Cure of ALS (ENCALS) Risk Factor as those with a higher risk for rapid disease progression, comprise approximately 50% of the total ALS population.

欧洲ALS治愈网络（ENCALS）风险因素将高风险患者定义为疾病快速进展风险较高的患者，约占ALS总人口的50%。

'The impressive results of these new analyses raise further enthusiasm for the potential impact of PrimeC on people with ALS. With the magnitude of its effect and consistency across subgroups, PrimeC, if approved following a Phase 3 trial, could significantly improve the standard of care for people with ALS,' commented Jeremy M.

“这些新分析的令人印象深刻的结果进一步激发了人们对PrimeC对ALS患者潜在影响的热情。Jeremy M.评论道，PrimeC在第三阶段试验后获得批准，其效果和亚组间的一致性都很强，可以显着提高ALS患者的护理标准。

Shefner M.D., Ph.D., Professor of Neurology at the Barrow Neurological Institute, Phoenix, Ariz., and a NeuroSense advisor..

谢夫纳（Shefner M.D.），博士，亚利桑那州凤凰城巴罗神经研究所神经病学教授。，还有一位神经官能症顾问。。

In addition to the subgroup of high-risk patients, patients treated with PrimeC who had symptoms for up to 12 months prior to the baseline visit (newly diagnosed patients), showed a 52% slowing of disease progression (p=0.008) versus placebo in the PP population analysis. This translates to a 7.76-point difference in the ALSFRS-R in favor of PrimeC (Confidence Interval: 2.27, 13.25; n=22).

除了高危患者亚组外，在基线访视前有症状长达12个月的PrimeC治疗患者（新诊断患者）与安慰剂相比，疾病进展减慢了52%（p=0.008）在PP人群分析中。这意味着ALSFRS-R的7.76点差异有利于PrimeC（置信区间：2.27、13.25；n=22）。

These subgroup analyses provide data suggesting consistent, statistically significant effect of PrimeC on the range of participants within the PARADIGM study..

这些亚组分析提供的数据表明，PrimeC对PARADIGM研究中参与者的范围具有一致的统计学显着影响。。

In the Intent-to-treat (ITT) population, high-risk ALS patients treated with PrimeC experienced a 31% (p=0.13) reduction in disease progression, which translates to a 3.2 points difference in the ALSFRS-R in favor of PrimeC (Confidence Interval: -1.03, 7.43; n=41). In addition, in the group of participants who had symptoms for up to 12 months prior to l the baseline visit (newly diagnosed patients) experienced a 36% reduction (p=0.14), which translates to a 4.56-point difference in the ALSFRS-R in favor of PrimeC (Confidence Interval: -1.6, 10.72; n=25)..

在意向治疗（ITT）人群中，接受PrimeC治疗的高危ALS患者的疾病进展减少了31%（p=0.13），这意味着ALSFRS-R的差异为3.2分，有利于PrimeC（置信区间：-1.03，7.43；n=41）。此外，在基线访视（新诊断患者）之前出现症状长达12个月的参与者组中，基线访视（新诊断患者）减少了36%（p=0.14），这意味着ALSFRS-R的4.56点差异有利于PrimeC（置信区间：-1.6，10.72；n=25）。。

Additional results of the subgroup analysis of the effect of PrimeC versus placebo on ALSFRS-R showed:

PrimeC与安慰剂对ALSFRS-R影响的亚组分析的其他结果显示：

Participants with a disease duration of up to 18 months (PP analysis), PrimeC demonstrated a 38% change (p=0.054)

疾病持续时间长达18个月的参与者（PP分析），PrimeC表现出38%的变化（p=0.054）

Participants with a disease duration of up to 24 months (PP analysis), PrimeC demonstrated 37% reduction in symptom scores (p=0.047)

疾病持续时间长达24个月的参与者（PP分析），PrimeC的症状评分降低了37%（p=0.047）

The Company plans to utilize these subgroup analyses to help inform the design of the upcoming pivotal trial, which the Company believes will increase its probability of success and its cost-effectiveness.

该公司计划利用这些亚组分析来帮助为即将到来的关键试验的设计提供信息，该公司认为这将增加其成功的可能性和成本效益。

Alon Ben-Noon, NeuroSense's CEO commented, 'We believe this is one of the most compelling results seen to-date in an advanced, double-blind clinical trial in ALS, demonstrating slowing the progression of ALS in patients in earlier stages with an aggressive disease.  Seeing PrimeC's significant impact in the general PARADIGM population in all various clinical aspects, and even more in multiple sub-groups on the gold-standard ALSFRS-R, is truly gratifying, and we are looking forward to analyzing and reporting on the 12-month study survival data in the next few weeks.'.

NeuroSense首席执行官阿隆·本·诺恩（Alon Ben Noon）评论道：“我们认为这是迄今为止在ALS的高级双盲临床试验中看到的最令人信服的结果之一，证明了在侵袭性疾病的早期阶段减缓了ALS患者的进展。看到PrimeC在所有临床方面对一般范式人群产生的重大影响，甚至在金标准ALSFRS-R的多个亚组中产生的影响，确实令人满意，我们期待着在未来几周内分析和报告12个月的研究生存数据。”。

About ALS

关于ALS

Amyotrophic lateral sclerosis ('ALS') is an incurable neurodegenerative disease that causes complete paralysis and death within 2-5 years from diagnosis. Every year, more than 5,000 people are diagnosed with ALS in the U.S. alone, with an annual disease burden of $1 billion. The number of people living with ALS is expected to grow by 24% by 2040 in the U.S.

肌萎缩侧索硬化症（ALS）是一种无法治愈的神经退行性疾病，在诊断后2-5年内导致完全瘫痪和死亡。仅在美国，每年就有5000多人被诊断出患有ALS，每年的疾病负担为10亿美元。预计到2040年，美国ALS患者人数将增长24%。

and EU..

和欧盟。。

About ALSFRS-R

关于ALSFRS-R

Disease progression is measured by the ALS Functional Rating Scale-Revised (ALSFRS-R), which is the most widely used ALS tracking tool accepted by the FDA, utilized by neurologists treating ALS patients, in clinical trials, and by other regulators to determine disease progression. It tracks 12 changes in a person's physical abilities over time including functions such as: speech, walking, climbing stairs, dressing/hygiene, handwriting, turning in bed, cutting food, salivation, swallowing, and breathing.

疾病进展通过修订的ALS功能评定量表（ALSFRS-R）进行测量，该量表是FDA接受的最广泛使用的ALS跟踪工具，用于治疗ALS患者的神经科医生，临床试验和其他监管机构确定疾病进展。它跟踪一个人身体能力随时间的12个变化，包括功能，如：言语、行走、爬楼梯、穿衣/卫生、书写、床上翻身、切食物、流涎、吞咽和呼吸。

A single point change on the ALSFRS-R has a significant impact on ALS patients, such as the transition from independent feeding to requiring assistance or independent breathing to needing to use a machine ventilator..

ALSFRS-R的单点变化对ALS患者有重大影响，例如从独立喂养过渡到需要帮助或独立呼吸，再到需要使用呼吸机。。

About PARADIGM

关于PARADIGM

PARADIGM is a prospective, multinational, randomized, double-blind, placebo-controlled Phase 2b (NCT05357950) clinical trial of PrimeC in ALS. The trial included 68 participants living with ALS in Canada, Italy, and Israel. 96% of the trial participants who completed the 6-month double-blind portion of the trial chose to receive treatment with PrimeC through a 12-month open label extension.

PARADIGM是PrimeC在ALS中的一项前瞻性，多国，随机，双盲，安慰剂对照2b期（NCT05357950）临床试验。该试验包括加拿大，意大利和以色列的68名ALS患者。完成6个月双盲部分试验的96%的试验参与者选择通过12个月的开放标签延长接受PrimeC治疗。

Furthermore, to date all participants that completed the 18-month trial treatment duration, requested to continue PrimeC, which is provided to them in an Investigator Initiated Trial, not limited with time..

此外，迄今为止，所有完成18个月试验治疗期的参与者都要求继续PrimeC，这是在研究者发起的试验中提供给他们的，不受时间限制。。

As previously reported, top-line data from the 6-month double-blind segment of the trial showed clinically meaningful signs of efficacy with a 29% difference in ALSFRS-R (p=0.12) and a 13% difference in SVC (p=0.5), both in favor of PrimeC vs placebo in analysis of the intent to treat (ITT) population.

如先前报道，来自6个月双盲试验的顶线数据显示临床上有意义的疗效迹象，ALSFRS-R差异29%（p=0.12），SVC差异13%（p=0.5），在意向治疗（ITT）人群分析中均支持PrimeC与安慰剂。

These data include all 68 people living with ALS enrolled in Canada, Italy, and Israel, with the exclusion of one patient who was misdiagnosed. In the PP top-line analysis from PARADIGM, a statistically significant slowing of disease progression was observed with a 37.4% (p=0.03) difference in ALSFRS-R in favor of PrimeC vs placebo.

这些数据包括在加拿大，意大利和以色列登记的所有68名ALS患者，其中不包括一名被误诊的患者。在PARADIGM的PP顶层分析中，观察到疾病进展的统计学显着减慢，ALSFRS-R的差异为37.4%（p=0.03），有利于PrimeC与安慰剂。

Most patients enrolled in both the active and placebo arms of the trial were concurrently treated with Riluzole, the ALS standard of care medication, indicating PrimeC slowed disease progression well beyond the level afforded by the FDA approved ALS drug.   .

参加试验的活性组和安慰剂组的大多数患者同时接受了利鲁唑（ALS标准护理药物）的治疗，这表明PrimeC减缓了疾病进展，远远超过了FDA批准的ALS药物所提供的水平。。

About PrimeC

PrimeC关于PrimeC

PrimeC, NeuroSense's lead drug candidate, is a novel extended-release oral formulation composed of a unique fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib. PrimeC is designed to synergistically target several key mechanisms of ALS that contribute to motor neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid ('RNA') regulation to potentially inhibit the progression of ALS.

PrimeC是NeuroSense的主要候选药物，是一种新型缓释口服制剂，由两种FDA批准的药物环丙沙星和塞来昔布的独特固定剂量组合组成。PrimeC旨在协同靶向ALS的几种关键机制，这些机制有助于运动神经元变性，炎症，铁积累和核糖核酸（“RNA”）调节受损，从而可能抑制ALS的进展。

NeuroSense completed a Phase 2a clinical trial which met its safety and efficacy endpoints including reducing functional and respiratory deterioration and statistically significant changes in ALS-related biological markers indicating PrimeC's biological activity. PrimeC was granted Orphan Drug Designation by the U.S.

NeuroSense完成了一项2a期临床试验，该试验符合其安全性和有效性终点，包括减少功能和呼吸恶化，以及表明PrimeC生物活性的ALS相关生物标志物的统计学显着变化。PrimeC被美国授予孤儿药称号。

Food and Drug Administration and the European Medicines Agency..

美国食品和药物管理局和欧洲药品管理局。。

About NeuroSense

关于NeuroSense

NeuroSense Therapeutics, Ltd. is a clinical-stage biotechnology company focused on discovering and developing treatments for patients suffering from debilitating neurodegenerative diseases. NeuroSense believes that these diseases, which include amyotrophic lateral sclerosis (ALS), Alzheimer's disease and Parkinson's disease, among others, represent one of the most significant unmet medical needs of our time, with limited effective therapeutic options available for patients to date.

NeuroSense Therapeutics，Ltd.是一家临床阶段生物技术公司，专注于为患有衰弱性神经退行性疾病的患者发现和开发治疗方法。NeuroSense认为，这些疾病，包括肌萎缩侧索硬化症（ALS），阿尔茨海默氏病和帕金森氏病等，代表了我们这个时代最重要的未满足的医疗需求之一，迄今为止，患者可用的有效治疗选择有限。

Due to the complexity of neurodegenerative diseases and based on strong scientific research on a large panel of related biomarkers, NeuroSense's strategy is to develop combined therapies targeting multiple pathways associated with these diseases..

由于神经退行性疾病的复杂性，并且基于对大量相关生物标志物的强大科学研究，NeuroSense的策略是开发针对与这些疾病相关的多种途径的联合疗法。。