Chronic spinal cord injury cohort results expected in mid-2024

慢性脊髓损伤队列结果预计在2024年中期

Subacute spinal cord injury cohort results expected in late 2024/early 2025

亚急性脊髓损伤队列结果预计在2024年底/2025年初

Vancouver, British Columbia--(Newsfile Corp. - September 25, 2023) - NervGen Pharma Corp. (TSXV: NGEN) (OTCQX: NGENF), a clinical stage biotech company dedicated to developing innovative solutions for the treatment of nervous system damage, today announced the first subject has been dosed in the Company's landmark Phase 1b/2a proof-of-concept placebo-controlled clinical trial for its proprietary lead compound, NVG-291, in individuals with spinal cord injury (SCI)..

温哥华，不列颠哥伦比亚省-（Newsfile Corp.-2023年9月25日）-NervGen Pharma Corp.（TSXV:NGEN）（OTCQX:NGENF），一家临床阶段生物技术公司，致力于开发治疗神经系统损害的创新解决方案，今天宣布，第一个受试者已在该公司具有里程碑意义的1b/2a期概念验证安慰剂对照临床试验中用于其专有先导化合物NVG-291，用于脊髓损伤（SCI）患者。。

'This is a significant milestone for NervGen and also an exciting day for individuals with spinal cord injury as we progress this first-in-kind product candidate into clinical studies,' said Mike Kelly, NervGen's President & CEO. 'This unique trial design will allow us to evaluate NVG-291's efficacy independently for each cohort of subjects - subacute and chronic.

NervGen总裁兼首席执行官Mike Kelly说：“这是NervGen的一个重要里程碑，也是脊髓损伤患者激动人心的一天，因为我们将这一第一批同类产品候选产品推向临床研究。”这种独特的试验设计将使我们能够独立评估NVG-291对每个受试者队列的疗效-亚急性和慢性。

We believe the results of this research study will be a key enabling step that may bring us closer to the first approved therapy for spinal cord injury, and we look forward to the prospect of delivering positive results next summer.'.

我们相信这项研究的结果将是一个关键的有利步骤，可能使我们更接近首次批准的脊髓损伤治疗方法，我们期待着明年夏天取得积极成果的前景。

Given there are approximately 300,000 people with SCI living in the United States alone, the limited number of clinical trials in this area and the tremendous anticipation for this trial within the SCI community, recruitment for the chronic cohort (1-10 years post injury) is anticipated to happen relatively quickly with results expected by mid-2024.

鉴于仅在美国就有大约30万SCI患者，该领域的临床试验数量有限以及SCI社区对该试验的巨大期望，慢性队列（受伤后1-10年）的招募预计将相对较快地发生，预计到2024年中期结果将会出现。

Results from the subacute cohort (10-49 days post-injury) are expected in late 2024/early 2025. The trial is being conducted at Shirley Ryan AbilityLab in Chicago, a global leader in physical medicine and rehabilitation for adults and children with the most severe and complex conditions..

亚急性队列（伤后10-49天）的结果预计在2024年底/2025年初。该试验正在芝加哥的Shirley Ryan AbilityLab进行，该公司是成人和儿童身体医学和康复的全球领导者，病情最严重和最复杂。。

'Our team at Shirley Ryan AbilityLab is excited to have begun investigational treatment in this important clinical research trial in individuals with spinal cord injury,' stated Monica A. Perez, PT, PhD, Scientific Chair of the Arms + Hands Lab at Shirley Ryan AbilityLab; Professor of Physical Medicine & Rehabilitation at Northwestern University; Research Scientist at the Edward Hines Jr.

“我们在Shirley Ryan AbilityLab的团队很高兴在这项针对脊髓损伤患者的重要临床研究试验中开始进行研究性治疗，”Shirley Ryan AbilityLab的Arms+Hands Lab科学主席Monica A.Perez博士说；西北大学物理医学与康复教授；Edward Hines Jr.的研究科学家。

VA Hospital; and the principal investigator of this trial. 'We look forward to fully recruiting this study and executing upon this innovative trial, which has the potential to change how we design and implement SCI clinical studies in the future.'.

VA医院；和这个试验的学术带头人我们期待全面招募这项研究并实施这项创新性试验，这有可能改变我们未来设计和实施SCI临床研究的方式。

About the NVG-291 Phase 1b/2a Trial

关于NVG-291 1b/2a期试验

The placebo-controlled proof-of-concept trial (NCT05965700) will evaluate the efficacy of NVG-291 in two separate cohorts of individuals with cervical spinal cord injury: chronic (1-10 years post-injury) and subacute (10-49 days post-injury), given demonstrated efficacy in preclinical models of both chronic and acute spinal cord injury.

安慰剂对照的概念验证试验（NCT05965700）将评估NVG-291在两个独立的颈脊髓损伤患者队列中的疗效：慢性（损伤后1-10年）和亚急性（10-49天）损伤后），在慢性和急性脊髓损伤的临床前模型中证明有效。

The trial is designed to evaluate efficacy of a fixed dose of NVG-291 using multiple clinical outcome measures as well as objective electrophysiological and MRI imaging measures and blood biomarkers that together will provide comprehensive information about the extent of recovery of function, with a focus on improvements in motor function.

该试验旨在使用多种临床结果测量以及客观的电生理和MRI成像测量以及血液生物标志物来评估固定剂量的NVG-291的功效，这些测量和血液生物标志物将一起提供关于功能恢复程度的全面信息，重点在于改善运动功能。

Specifically, the primary objective is to assess the change in corticospinal connectivity of defined upper and lower extremity muscle groups following treatment based on changes in motor evoked potential amplitudes. Secondary objectives are to evaluate changes in a number of clinical outcome assessments focusing on motor function, upper extremity dexterity and grasping and mobility, as well as changes in additional electrophysiological measurements.

具体而言，主要目的是根据运动诱发电位幅度的变化评估治疗后确定的上肢和下肢肌肉群的皮质脊髓连接的变化。次要目标是评估一些临床结果评估的变化，重点是运动功能，上肢灵活性和抓握和活动性，以及额外电生理测量的变化。

Each cohort will be evaluated independently as the data becomes available. The trial is being partially funded by a grant from Wings for Life, which is to be provided in several milestone-based payments and will offset a portion of the direct costs of this clinical trial..

当数据可用时，将独立评估每个队列。该试验的部分资金来自Wings for Life的赠款，该赠款将以几个里程碑式的付款方式提供，并将抵消该临床试验的一部分直接费用。。

About Shirley Ryan AbilityLab

关于雪莉-瑞安AbilityLab

Shirley Ryan AbilityLab, formerly the Rehabilitation Institute of Chicago (RIC), is the global leader in physical medicine and rehabilitation for adults and children with the most severe, complex conditions - from traumatic brain and spinal cord injury to stroke, amputation and cancer-related impairment.

Shirley Ryan AbilityLab，前身为芝加哥康复研究所（RIC），是成人和儿童物理医学和康复的全球领导者，患有最严重，最复杂的疾病-从创伤性脑和脊髓损伤到中风，截肢和癌症相关障碍。

The organization expands and accelerates leadership in the field that began at RIC in 1953. The quality of its care has led to the designation of 'No. 1 Rehabilitation Hospital in America' by U.S. News & World Report every year since 1991. Upon opening in 2017, the $550 million, 1.2-million-square-foot Shirley Ryan AbilityLab became the first-ever 'translational' research hospital in which clinicians, scientists, innovators and technologists work together in the same space, surrounding patients, discovering new approaches and applying (or 'translating') research real time.

该组织扩大并加速了1953年在RIC开始的该领域的领导力。其护理质量导致了“否”的指定。自1991年以来，美国新闻与世界报道每年都有1家美国康复医院。2017年开课后，价值5.5亿美元，120万平方英尺的雪莉·瑞安·阿比利蒂拉布成为有史以来第一家“转化”研究医院，临床医生，科学家，创新者和技术人员在同一空间，周围患者，发现新方法并实时应用（或“翻译”）研究。

This unique model enables patients to have 24/7 access to the brightest minds, the latest research and the best opportunity for recovery. Shirley Ryan AbilityLab is a 501 (c)(3) non-profit organization. For more information, go to www.sralab.org..

这种独特的模式使患者能够全天候地获得最聪明的头脑，最新的研究和最佳的康复机会。Shirley Ryan AbilityLab是一家501（c）（3）非营利组织。欲了解更多信息，请访问www.sralab.org。。

About Wings for Life Accelerated Translational Program

关于生命加速翻译计划的翅膀

Even with very promising discoveries, the translation from scientific discovery to applied therapeutics is a long and difficult road due to regulatory burdens, complexities of clinical trial design, patient recruitment and retention barriers, and the high cost of cutting-edge research. The Wings for Life Accelerated Translational Program (ATP) has been specifically designed to be able to accommodate obstacles to efficient clinical translation..

即使有非常有希望的发现，由于监管负担，临床试验设计的复杂性，患者招募和保留障碍以及尖端研究的高成本，从科学发现到应用治疗的翻译也是一条漫长而艰难的道路。生命之翼加速翻译程序（ATP）专门设计用于能够适应有效临床翻译的障碍。。

The ATP strives to assist applicants to find the best way forward in clinical translation of high caliber, promising therapies. The ATP is supported by a network of clinicians, scientists, and other professionals with expertise in all aspects of clinical trials. Select members of the ATP Support Network will be called upon, as required, to assist in ensuring that treatments with auspicious potential are translated in the most scientifically rigorous and efficient way possible..

ATP努力帮助申请人在高质量，有前景的疗法的临床翻译中找到最佳的方法。ATP由在临床试验各个方面具有专业知识的临床医生，科学家和其他专业人员组成的网络支持。根据需要，将呼吁选定的ATP支持网络成员，以协助确保以吉祥潜力的治疗方法以尽可能科学严谨和有效的方式进行翻译。。

About NVG-291

关于NVG-291

NervGen holds exclusive worldwide rights to NVG-291, a first-in-class therapeutic peptide targeting mechanisms that interfere with nervous system repair. NVG-291 is derived from the intracellular wedge domain of the receptor type protein tyrosine phosphatase sigma (PTPσ). NVG-291-R, a rodent analog of NVG-291, has been shown to promote nervous system repair and functional recovery in animal models of spinal cord injury (acute and chronic intervention), peripheral nerve injury, multiple sclerosis and stroke, through enhanced plasticity, axonal regeneration, and remyelination..

NervGen拥有NVG-291的独家全球权利，NVG-291是一种一流的治疗性肽靶向机制，可干扰神经系统修复。NVG-291衍生自受体型蛋白酪氨酸磷酸酶sigma（PTPσ）的细胞内楔形结构域。NVG-291-R是NVG-291的啮齿动物类似物，已被证明可通过脊髓损伤（急性和慢性干预），周围神经损伤，多发性硬化和中风的动物模型促进神经系统修复和功能恢复。增强可塑性，轴突再生和髓鞘再生。。

About NervGen

关于NervGen

NervGen (TSXV: NGEN) (OTCQX: NGENF) is a clinical stage biotech company dedicated to developing innovative treatments that enable the nervous system to repair itself following damage, whether due to injury or disease. NervGen's lead drug candidate, NVG-291, is being evaluated in a Phase 1b/2a clinical trial.

NervGen（TSXV:NGEN）（OTCQX:NGENF）是一家临床阶段生物技术公司，致力于开发创新疗法，使神经系统能够在受伤或疾病后自我修复。NervGen的主要候选药物NVG-291正在1b/2a期临床试验中进行评估。

The Company's initial target indication is spinal cord injury. For more information, go to www.nervgen.com and follow NervGen on Twitter, LinkedIn, and Facebook for the latest news on the Company..

该公司最初的目标指征是脊髓损伤。欲了解更多信息，请访问www.nervgen.com并关注Twitter，LinkedIn和Facebook上的nervgen，了解公司的最新消息。。

Contacts

联络

Huitt Tracey, Corporate Communications

Huitt Tracey，公司通讯

htracey@nervgen.com

htracey@nervgen.com

604.537.2094

604.537.2094

Nancy Thompson, Vorticom Public Relations

Nancy Thompson，Vorticom公共关系

nancyt@vorticom.com

nancyt@vorticom.com

212.532.2208

212.532.2208

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

TSX Venture Exchange及其监管服务提供商（如TSX Venture Exchange的政策中定义的那样）均不对本版本的充分性或准确性承担责任。

Cautionary Note Regarding Forward-Looking Statements

关于前瞻性陈述的警示

This news release may contain 'forward-looking information' and 'forward-looking statements' within the meaning of applicable Canadian and United States securities legislation. Such forward-looking statements and information herein include, but are not limited to, the Company's current and future plans, expectations and intentions, results, levels of activity, performance, goals or achievements, or any other future events or developments constitute forward-looking statements, and the words 'may', 'will', 'would', 'should', 'could', 'expect', 'plan', 'intend', 'trend', 'indication', 'anticipate', 'believe', 'estimate', 'predict', 'likely' or 'potential', or the negative or other variations of these words or other comparable words or phrases, are intended to identify forward-looking statements.

本新闻稿可能包含适用的加拿大和美国证券立法含义内的“前瞻性信息”和“前瞻性声明”。此类前瞻性陈述和信息包括但不限于公司当前和未来的计划，期望和意图，结果，活动水平，绩效，目标或成就，或任何其他未来事件或发展构成前瞻性陈述，以及“可能”，“将会”，“将会”，“应该”，“可能”，“期望”，“计划”，“意图”，“趋势”，“指示”，“预期”，“相信”，“估计”，“预测”，“可能”或“潜力”，或这些单词或其他可比较单词或短语的负面或其他变体，旨在识别前瞻性陈述。

Forward-looking statements include, without limitation, statements relating to: the objectives, timing, rate of subject recruitment and study design of the clinical development of NVG-291 including the planned single site Phase 1b/2a clinical trial in SCI with Shirley Ryan AbilityLab; our belief that the results of the Phase 1b/2a clinical trial will enable us to evaluate NVG-291's efficacy independently for each cohort of subjects and advance our clinical pathway to approval; the innovative aspect of the trial having the potential to change the design of SCI clinical trials in the future; the receipt of the milestone-based grant payments and the potential assistance from ATP; the belief that targeting mechanisms that interfere with nervous system repair is a promising target for reducing the clinical effects of nervous system damage through multiple mechanisms; and the creation of innovative treatments of nervous system damage due to trauma or disease..

前瞻性陈述包括但不限于以下陈述：NVG-291临床开发的目标，时间，受试者招募率和研究设计，包括计划在Shirley-Ryan SCI进行的单点1b/2a期临床试验AbilityLab；我们相信1b/2a期临床试验的结果将使我们能够独立评估NVG-291对每个受试者队列的疗效，并推动我们的临床路径获得批准；该试验的创新方面有可能改变未来SCI临床试验的设计；收到基于里程碑的赠款付款和ATP的潜在援助；认为干扰神经系统修复的靶向机制是通过多种机制降低神经系统损伤的临床效果的有希望的目标；以及创造创伤或疾病引起的神经系统损伤的创新治疗方法。。

Forward-looking statements are based on estimates and assumptions made by the Company in light of management's experience and perception of historical trends, current conditions and expected future developments, as well as other factors that we believe are appropriate and reasonable in the circumstances.

前瞻性陈述基于公司根据管理层对历史趋势，现状和预期未来发展的经验和看法所作的估计和假设，以及我们认为在这种情况下适当和合理的其他因素。

In making forward-looking statements, the Company has relied on various assumptions, including, but not limited to: the Company's ability to manage the effects of the COVID-19 pandemic; the accuracy of the Company's financial projections; the Company obtaining positive results in its clinical and other trials; the Company obtaining necessary regulatory approvals; and general business, market and economic conditions..

在做出前瞻性陈述时，公司依赖各种假设，包括但不限于：公司管理COVID-19大流行影响的能力；公司财务预测的准确性；公司在临床和其他试验中取得积极成果；公司获得必要的监管批准；和一般业务，市场和经济条件。。

Many factors could cause our actual results, level of activity, performance or achievements or future events or developments to differ materially from those expressed or implied by the forward-looking statements, including without limitation, a lack of revenue, insufficient funding, the impact of the COVID-19 pandemic, reliance upon key personnel, the uncertainty of the clinical development process, competition, and other factors set forth in the 'Risk Factors' section of the Company's Annual Information Form, Short Form Base Shelf Prospectus, financial statements and Management Discussion and Analysis which can be found on SEDARplus.ca.

许多因素可能导致我们的实际结果，活动水平，绩效或成就或未来事件或发展与前瞻性声明所表达或暗示的结果大不相同，包括但不限于收入不足，资金不足，影响新型冠状病毒肺炎流行，依赖关键人员，本公司年度信息表“风险因素”部分，简表基本货架说明书，财务报表和管理层讨论与分析中规定的临床开发过程，竞争等因素的不确定性可在SEDARplus.ca上找到。

All clinical development plans are subject to additional funding..

所有的临床开发计划都需要额外的资金。。

Readers should not place undue reliance on forward-looking statements made in this news release. Furthermore, unless otherwise stated, the forward-looking statements contained in this news release are made as of the date of this news release, and we have no intention and undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.

读者不应该过分依赖本新闻稿中的前瞻性陈述。此外，除非另有说明，否则本新闻稿中包含的前瞻性声明是截至本新闻稿发布之日作出的，除适用法律要求外，我们无意并且不承担更新或修改任何前瞻性声明的义务，无论是由于新信息，未来事件或其他原因。

The forward-looking statements contained in this news release are expressly qualified by this cautionary statement..

本新闻稿中包含的前瞻性声明受到本警示性声明的明确限制。。

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/181784

要查看此新闻稿的源版本，请访问https://www.newsfilecorp.com/release/181784