VANCOUVER, British Columbia & DALLAS--(BUSINESS WIRE)--Alpha Cognition (CSE: ACOG) (OTCQB: ACOGF) (Alpha Cognition “ACI”, or the “Company”), a biopharmaceutical company developing novel therapeutics for debilitating neurodegenerative disorders, announces that the U.S. Food and Drug Administration (FDA) has granted approval for ZUNVEYL® (benzgalantamine) previously known as ALPHA-1062, for the treatment of mild-to-moderate Alzheimer's disease.

温哥华，不列颠哥伦比亚省和达拉斯市——（商业新闻短讯）——Alpha Cognition（CSE:ACOG）（OTCQB:ACOGF），一家开发用于衰弱神经退行性疾病的新型治疗剂的生物制药公司，宣布美国食品和药物管理局（FDA）已批准ZUNVEYL®（苯加兰他敏），以前称为Alpha-1062，用于治疗轻度至中度阿尔茨海默病。

Alzheimer’s disease (AD) is a progressive brain disorder that slowly destroys memory, thinking skills, and eventually the ability to do simple tasks, like carry on a conversation. AD is the most common form of dementia affecting nearly 7 million people, and is the leading cause of nursing home admissions and deaths, with 70% of all nursing home residents suffering with AD.

阿尔茨海默氏病（AD）是一种进行性脑部疾病，会慢慢破坏记忆力、思维能力，并最终破坏完成简单任务（如进行对话）的能力。

A novel oral therapy, ZUNVEYL has a dual mechanism of action designed to eliminate drug absorption in the GI tract, potentially addressing certain tolerability issues with leading AD medications, combined with the efficacy and long-term benefit profile of galantamine. Tolerability affects therapy adherence, with data showing that 55% of AD patients discontinue their medication after one year, mainly due to GI side effects and insomnia.

ZUNVEYL是一种新型口服疗法，具有双重作用机制，旨在消除胃肠道中的药物吸收，可能解决主要AD药物的某些耐受性问题，并结合加兰他敏的疗效和长期益处。耐受性影响治疗依从性，数据显示55%的AD患者在一年后停止服药，主要是由于胃肠道副作用和失眠。

Medication discontinuation can cause risk to patients themselves, and dissatisfaction and burden among nursing home staff, physicians, and caregivers..

停药可能会给患者本身带来风险，也会给疗养院工作人员、医生和护理人员带来不满和负担。。

ZUNVEYL, a prodrug of AD treatment galantamine and an acetylcholinesterase inhibitor (AChEI), is postulated to exert its therapeutic effect by preventing the breakdown of acetylcholine, the important brain neurotransmitter involved in memory, motivation, and attention functions. It is also an allosteric potentiator of α-7 nicotinic acetylcholine and α4β2 receptors.

ZUNVEYL是AD治疗加兰他敏和乙酰胆碱酯酶抑制剂（AChEI）的前药，被认为可以通过阻止乙酰胆碱的分解来发挥其治疗效果，乙酰胆碱是参与记忆，动机和注意力功能的重要脑神经递质。它也是α-7烟碱型乙酰胆碱和α4β2受体的变构增强剂。

This action facilitates the release of acetylcholine from the presynaptic neurons, giving clinical significance to its dual mode of action. ZUNVEYL targets AD symptoms, to provide patients with long-lasting benefits to cognitive and global function and the ability to perform daily activities that are impaired by AD.

这种作用有助于从突触前神经元释放乙酰胆碱，使其双重作用模式具有临床意义。ZUNVEYL针对AD症状，为患者提供认知和全球功能的长期益处，以及进行AD损害的日常活动的能力。

Galantamine, FDA-approved since 2001, has extensive and positive data related to long-term outcomes, demonstrating activity among multiple brain receptors, anti-inflammatory effects, and is associated with improved memory, attention, and a significantly lower risk of death. It also has the strongest effect on cognitive decline in the AChEI class of medications and demonstrated significant risk reduction of developing severe dementia.

自2001年以来，FDA批准的加兰他敏具有与长期结果相关的广泛而积极的数据，证明了多种大脑受体的活性，抗炎作用，并且与改善记忆力，注意力和显着降低死亡风险有关。它对AChEI类药物的认知能力下降也有最强的影响，并显示出显着降低患严重痴呆症的风险。

Due to its prodrug properties, ZUNVEYL is effectively converted into the active moiety of galantamine after it passes through the GI tract, therefore achieving the same therapeutic effects of galantamine. It was also uniquely designed to eliminate drug absorption in the GI tract, potentially addressing certain tolerability issues and has a CNS safety profile that includes no incidence of insomnia.

由于其前药特性，ZUNVEYL在通过胃肠道后有效地转化为加兰他敏的活性部分，因此实现了与加兰他敏相同的治疗效果。它还被独特地设计用于消除胃肠道中的药物吸收，可能解决某些耐受性问题，并且具有中枢神经系统安全性，不包括失眠的发生率。

Information about ZUNVEYL’s pivotal clinical studies are included further in this press release, and in the ZUNVEYL prescribing information..

关于ZUNVEYL关键临床研究的信息进一步包含在本新闻稿和ZUNVEYL处方信息中。。

“I am very excited about the approval of ZUNVEYL, which we believe offers better tolerability for patients with Alzheimer's disease. We have always believed in the efficacy of galantamine but have been limited in its use due to tolerability issues. To now have an agent with the efficacy of galantamine, but that also offers the hope of better tolerability, will provide physicians a great option to treat patients,” said Elaine Peskind, MD, the Friends of Alzheimer’s Research Professor of Psychiatry at the University of Washington School of Medicine.

华盛顿大学医学院阿尔茨海默病研究精神病学之友医学博士Elaine Peskind说：“我对ZUNVEYL的批准感到非常兴奋，我们认为ZUNVEYL可以为阿尔茨海默病患者提供更好的耐受性。我们一直相信加兰他敏的疗效，但由于耐受性问题，它的使用受到限制。现在有一种具有加兰他敏疗效的药物，但也提供了更好耐受性的希望，这将为医生治疗患者提供一个很好的选择。”。

“This advancement marks a meaningful step forward in improving the quality of life for those living with Alzheimer's and their families. As a geriatric psychiatrist specializing in Alzheimer’s disease, I am eager to incorporate this new treatment into our practice and see the positive difference it will make.”.

“这一进步标志着在改善阿尔茨海默氏病患者及其家人的生活质量方面迈出了有意义的一步。作为一名专门研究阿尔茨海默氏病的老年精神病医生，我渴望将这种新疗法纳入我们的实践中，并看到它将产生积极的影响。”。

“The approval of ZUNVEYL is a pivotal moment in the fight against Alzheimer's disease as it is only the second oral AD treatment to be approved in more than a decade. ZUNVEYL was designed to addresses a critical need for a tolerable and effective treatment that can potentially enhance patients' daily lives with improved long-term outcomes,” stated Alpha Cognition Chief Executive Officer Michael McFadden.

阿尔法认知首席执行官迈克尔·麦克法登（MichaelMcFadden）表示：“ZUNVEYL的批准是对抗阿尔茨海默氏病的关键时刻，因为这只是十多年来第二次获得批准的口服AD治疗。ZUNVEYL的目的是满足对耐受性和有效治疗的迫切需求，这种治疗可以潜在地改善患者的日常生活，改善长期预后。”。

“We are delighted, as this represents a major breakthrough in Alzheimer's treatment, providing hope to millions of patients, families, and caregivers affected by this devastating disease.”.

“我们很高兴，因为这代表了阿尔茨海默病治疗的重大突破，为数百万受这种毁灭性疾病影响的患者、家属和护理人员带来了希望。”。

About the Pivotal ZUNVEYL Clinical Studies

关于关键的ZUNVEYL临床研究

ZUNVEYL’s approval was based on chemistry, manufacturing, and controls information and data demonstrating the bioequivalence and tolerability of ZUNVEYL compared to galantamine immediate-release tablets and galantamine extended-release capsules. Importantly, there were minimal adverse events reported in these trials..

ZUNVEYL的批准基于化学，制造和控制信息和数据，证明了与加兰他敏速释片和加兰他敏缓释胶囊相比，ZUNVEYL的生物等效性和耐受性。重要的是，这些试验报告的不良事件很少。。

Efficacy, Tolerability, Safety: The efficacy of ZUNVEYL is based upon 3 bioavailability studies in healthy adults comparing galantamine immediate-release tablets and galantamine extended-release capsules to ZUNVEYL. GI adverse events documented across all studies for ZUNVEYL were less than 2% and no insomnia was observed..

功效，耐受性，安全性：ZUNVEYL的功效基于健康成年人的3项生物利用度研究，比较加兰他敏速释片和加兰他敏缓释胶囊与ZUNVEYL。ZUNVEYL所有研究中记录的胃肠道不良事件均不到2%，未观察到失眠。。

Dual Mechanism of Action: While precise mechanism of action is not known, it is believed that ZUNVEYL works through two distinct pathways to enhance neurotransmitter activity and protect neuronal health, leading to improved cognitive and functional outcomes.

双重作用机制：虽然确切的作用机制尚不清楚，但据信ZUNVEYL通过两种不同的途径增强神经递质活性并保护神经元健康，从而改善认知和功能结果。

Long-Term Benefits: Clinical trials for galantamine (ZUNVEYL’s active moiety) have demonstrated sustained improvements in cognitive function and quality of life over extended periods of treatment.

长期益处：加兰他敏（ZUNVEYL的活性部分）的临床试验表明，在长期治疗期间，认知功能和生活质量持续改善。

Availability

可用性

ZUNVEYL will be available by prescription in pharmacies nationwide in Q1 2025. Alpha Cognition is committed to ensuring broad access to this innovative treatment and will work closely with healthcare providers, insurers, and patient advocacy groups to support its distribution.

ZUNVEYL将于2025年第一季度在全国药店按处方提供。Alpha认知致力于确保广泛获得这种创新治疗，并将与医疗保健提供者，保险公司和患者倡导团体密切合作，以支持其分发。

'We are excited to launch ZUNVEYL and bring this much-needed treatment option to patients suffering from Alzheimer's disease,' said Lauren D’Angelo, Alpha Cognition’s Chief Operating Officer. 'Over the coming months, our team will work diligently to prepare for this launch, ensuring that healthcare providers have the information and patients have the resources and support they need.

阿尔法认知公司首席运营官劳伦·德安杰洛（LaurenD'Angelo）说，我们很高兴推出ZUNVEYL，为患有阿尔茨海默病的患者带来这种急需的治疗选择在接下来的几个月里，我们的团队将努力为此次发布做好准备，确保医疗保健提供者拥有所需的信息，患者拥有所需的资源和支持。

ZUNVEYL offers dual-action benefits with the established efficacy of galantamine and no insomnia. It was uniquely designed to bypass the gut with the potential of minimizing GI side effects. We believe that ZUNVEYL’s unique combination of these attributes will make a meaningful difference in the lives of those affected by this debilitating disease.

ZUNVEYL具有加兰他敏的既定功效和无失眠的双重作用。它被独特地设计用于绕过肠道，有可能最大程度地减少胃肠道副作用。我们相信，ZUNVEYL这些特性的独特组合将对受这种衰弱疾病影响的人的生活产生有意义的影响。

We look forward to collaborating with our partners to ensure a successful rollout and broad accessibility.'.

我们期待着与我们的合作伙伴合作，以确保成功推出和广泛的可访问性。”。

About Alpha Cognition Inc.

关于Alpha认知公司。

Alpha Cognition Inc. is a clinical stage, biopharmaceutical company dedicated to developing treatments for patients suffering from neurodegenerative diseases, such as Alzheimer’s disease and Cognitive Impairment with mild Traumatic Brain Injury (“mTBI”), for which there are currently no approved treatment options..

Alpha Cognition是一家临床阶段的生物制药公司，致力于为患有神经退行性疾病的患者开发治疗方法，例如阿尔茨海默病和轻度创伤性脑损伤的认知障碍（“mTBI”），目前尚无批准的治疗方案。。

ZUNVEYL, previously ALPHA-1062, is a novel patented oral Alzheimer’s disease therapy with a dual mechanism of action designed to eliminate drug absorption in the GI tract, potentially addressing certain tolerability issues with leading AD medications, combined with the efficacy and long-term benefit profile of galantamine.

ZUNVEYL以前是ALPHA-1062，是一种新型专利口服阿尔茨海默病疗法，具有双重作用机制，旨在消除胃肠道中的药物吸收，可能解决主要AD药物的某些耐受性问题，并结合加兰他敏的疗效和长期益处。