CAMBRIDGE, Mass.--(BUSINESS WIRE)--Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced topline results from PHOENIX, a global, 48-week, randomized, placebo-controlled Phase 3 clinical trial of AMX0035 (sodium phenylbutyrate and taurursodiol [also known as ursodoxicoltaurine]; RELYVRIO® in the U.S., ALBRIOZA™ in Canada) in people living with amyotrophic lateral sclerosis (ALS).

马萨诸塞州剑桥市（商业新闻短讯）--Amylyx Pharmaceuticals，Inc.（纳斯达克：AMLX）（“Amylyx”或“公司”）今天宣布了PHOENIX的topline结果，这是一项为期48周的全球性随机安慰剂对照AMX0035（苯丁酸钠和牛磺索地尔[也称为熊去氧胆酸]；美国RELYVRIO®，加拿大ALBRIOZA™的3期临床试验）患有肌萎缩侧索硬化症（ALS）的人。

PHOENIX did not meet its primary endpoint of reaching statistical significance (p=0.667) as measured by change from baseline in the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) total score at Week 48, nor was there statistical significance seen in secondary endpoints. Amylyx plans to present the data from PHOENIX at an upcoming medical meeting and will publish the results in a medical journal later this year..

根据第48周修订的肌萎缩侧索硬化症功能评定量表（ALSFRS-R）总分与基线的变化，凤凰城没有达到达到统计学显着性（p=0.667）的主要终点，次要终点也没有统计学意义。Amylyx计划在即将举行的医学会议上展示来自凤凰城的数据，并将在今年晚些时候的医学期刊上公布结果。。

Amylyx will continue to engage with regulatory authorities and the broader ALS community, including ALS specialists and other multidisciplinary experts, people living with ALS, and advocates, to discuss the results from PHOENIX within the next eight weeks and make informed decisions. Amylyx intends to share plans for RELYVRIO/ALBRIOZA in ALS, which may include voluntarily withdrawing RELYVRIO/ALBRIOZA from the market.

Amylyx将继续与监管机构和更广泛的ALS社区接触，包括ALS专家和其他多学科专家、ALS患者和倡导者，在未来八周内讨论凤凰城的结果，并做出明智的决定。Amylyx打算在ALS分享RELYVRIO/ALBRIOZA的计划，其中可能包括自愿将RELYVRIO/ALBRIOZA退出市场。

At this time, RELYVRIO/ALBRIOZA and its related patient support program will continue to be available for people living with ALS. Amylyx has voluntarily decided to pause promotion of the medication during this time..

目前，RELYVRIO/ALBRIOZA及其相关的患者支持计划将继续为ALS患者提供服务。Amylyx自愿决定在此期间暂停药物的推广。。

“We are surprised and deeply disappointed by the PHOENIX results following the positive data from the CENTAUR trial. Our main priority at the moment is sharing the information with people living with ALS and their treating physicians; this is part of our continued commitment to them and our mission.

“在半人马座试验的积极数据之后，凤凰城的结果令我们感到惊讶和深感失望。目前我们的主要优先事项是与ALS患者及其治疗医生分享信息；这是我们对他们和我们使命的持续承诺的一部分。

Over the next eight weeks, our team will continue to engage with regulatory authorities and the ALS community to discuss the results from PHOENIX. We will be led in our decisions by two key principles: doing what is right for people living with ALS, informed by regulatory authorities and the ALS community, and by what the science tells us.

在接下来的八周内，我们的团队将继续与监管机构和ALS社区接触，讨论凤凰城的结果。我们的决策将遵循两个关键原则：在监管机构和ALS社区的知情下，做对ALS患者正确的事情，以及科学告诉我们的事情。

On behalf of the entire Amylyx team, we are grateful to the ALS community and for the dedication of trial participants, investigators, and study site teams. With data collected from 664 participants in PHOENIX, we are certain there will be important learnings that will help inform future ALS research.

我们代表整个Amylyx团队感谢ALS社区以及试验参与者，调查人员和研究现场团队的奉献精神。通过从凤凰城664名参与者那里收集的数据，我们确信会有重要的经验教训，这将有助于为未来的ALS研究提供信息。

We are steadfast in our commitment to the ALS community and our mission, including with AMX0035 where it has shown potential in neurodegenerative diseases such as Wolfram syndrome and progressive supranuclear palsy, and with AMX0114, our investigational antisense oligonucleotide targeting calpain-2, in ALS,” said Justin Klee and Joshua Cohen, Co-CEOs of Amylyx..

我们坚定地致力于ALS社区和我们的使命，包括AMX0035，它在Wolfram综合征和进行性核上性麻痹等神经退行性疾病中显示出潜力，以及AMX0114，我们针对ALS中钙蛋白酶-2的研究性反义寡核苷酸，”Amylyx的联合首席执行官贾斯汀·克莱和约书亚·科恩说。。

PHOENIX Study Results:

凤凰城研究结果：

The Phase 3 PHOENIX study enrolled 664 adults living with ALS. Participants were randomized three-to-two to receive either AMX0035 or placebo, with both treatment groups receiving standard-of-care. Continuation of a stable dosing regimen of riluzole and/or edaravone was permitted.

凤凰城的第三阶段研究招募了664名患有ALS的成年人。参与者被随机分为三到两组，接受AMX0035或安慰剂，两个治疗组均接受标准护理。允许继续使用利鲁唑和/或依达拉奉的稳定给药方案。

PHOENIX did not meet the primary endpoint: There was no significant difference observed between participants treated with AMX0035 and placebo in ALSFRS-R total score change from baseline at Week 48 (p=0.667). No significant difference was observed in the subset of participants who met the CENTAUR trial criteria.

PHOENIX没有达到主要终点：在第48周，用AMX0035和安慰剂治疗的参与者在ALSFRS-R总分与基线相比没有显着差异（p=0.667）。符合半人马座试验标准的参与者子集没有观察到显着差异。

There were also no significant differences observed across secondary endpoints..

次要终点之间也没有观察到显着差异。。

Consistent safety and tolerability profile: AMX0035 was well-tolerated in PHOENIX. There were no new safety signals, reinforcing the favorable and manageable safety profile observed with AMX0035 to date.

一致的安全性和耐受性概况：AMX0035在凤凰城的耐受性良好。迄今为止，没有新的安全信号，强化了AMX0035所观察到的有利且可管理的安全性。

European participants who completed the 48-week randomized phase had the option to enroll in an open label extension of the trial of up to two years in duration, which remains ongoing.

完成48周随机阶段的欧洲参与者可以选择参加为期两年的开放标签延长试验，该试验仍在进行中。

Science of AMX0035:

AMX0035科学：

AMX0035, a specially formulated oral fixed-dose combination of PB and TURSO, has been shown in numerous preclinical studies to have a robust, synergistic effect in targeting two different destructive neurodegenerative disease pathways by mitigating endoplasmic reticulum stress and the associated unfolded protein response and mitochondrial dysfunction thereby reducing neuronal cell death.

AMX0035是一种特殊配制的PB和TURSO口服固定剂量组合，已在许多临床前研究中显示，通过减轻内质网应激和相关的未折叠蛋白反应和线粒体功能障碍，在靶向两种不同的破坏性神经退行性疾病途径方面具有强大的协同作用，从而减少神经元细胞死亡。

Additionally, AMX0035 has been shown to also reduce markers associated with neurodegenerative diseases in clinical trials, including a reduction of tau, a key protein aggregate shared across several neurodegenerative diseases, and YKL-40, a marker of neuroinflammation..

此外，AMX0035在临床试验中也被证明可以减少与神经退行性疾病相关的标志物，包括减少tau（一种在几种神经退行性疾病中共享的关键蛋白聚集体）和YKL-40（一种神经炎症标志物）。。

Update on Ongoing AMX0035 Studies:

正在进行的AMX0035研究的最新情况：

The global, randomized, double-blind, placebo-controlled Phase 3 ORION clinical study of AMX0035 in PSP remains ongoing. The first participant was dosed in December 2023, and the Company is planning for an interim analysis. Topline results continue to be anticipated in 2025 or 2026.

AMX0035在PSP中的全球，随机，双盲，安慰剂对照的3期ORION临床研究仍在进行中。第一个参与者于2023年12月服用，该公司正在计划进行中期分析。预计2025年或2026年将继续取得最终成果。

Data from the ongoing 12-participant, single site, open-label Phase 2 HELIOS clinical study are demonstrating evidence of clinical activity of AMX0035 in Wolfram syndrome. This study is fully recruited, and the Company plans to present preliminary data in the second quarter of 2024.

来自正在进行的12名参与者，单点，开放标签的2期HELIOS临床研究的数据证明了AMX0035在Wolfram综合征中的临床活性。这项研究已全面招募，该公司计划在2024年第二季度提供初步数据。

Investor Conference Call Information

投资者电话会议信息

Amylyx’ management team will host a live conference call and webcast today, March 8, 2024, at 8:00 a.m. ET to discuss the results of the PHOENIX trial. To participate in the conference call, please dial +1 (877) 870-4263 (U.S.), +1 (855) 669-9657 (Canada), or +1 (412) 317-0790 (International) at least 10 minutes prior to the start time and ask to be joined into the Amylyx Pharmaceuticals call.

Amylyx的管理团队将于今天（2024年3月8日）上午8:00（美国东部时间）主持一次现场电话会议和网络直播，讨论菲尼克斯试验的结果。要参加电话会议，请在开始时间前至少10分钟拨打+1（877）870-4263（美国），+1（855）669-9657（加拿大）或+1（412）317-0790（国际），并要求加入Amylyx Pharmaceuticals呼叫。

All interested parties are invited to access a live broadcast of the call via a webcast, which will be available on the “Events and Presentations” page in the “Investors” section of the Company’s website at investors.amylyx.com/news-events/events. An archived webcast will be available on the Company's website approximately two hours after the conference call and will be available for replay for 90 days following the call..

邀请所有感兴趣的各方通过网络广播进行电话直播，该网络广播将在公司网站Investors.amylyx.com/news-Events/Events“Investors”部分的“Events and Presentations”页面上提供。电话会议后大约两小时，公司网站上将提供存档的网络广播，并可在通话后90天内进行重播。。

About the PHOENIX Trial

关于凤凰城审判

PHOENIX was a 48-week, randomized, placebo-controlled, global Phase 3 clinical trial further evaluating the safety and efficacy of AMX0035 (sodium phenylbutyrate and taurursodiol) for the treatment of ALS. The primary efficacy outcome of the trial was change from baseline in ALS Functional Rating Scale-Revised (ALSFRS-R) total score at 48 weeks.

PHOENIX是一项为期48周的随机安慰剂对照全球3期临床试验，进一步评估了AMX0035（苯丁酸钠和牛磺酸钠）治疗ALS的安全性和有效性。该试验的主要疗效结果是48周时ALS功能评定量表修订版（ALSFRS-R）总分与基线的变化。

Secondary endpoints include quality of life patient-reported outcome assessments, overall survival, and respiratory function as measured by slow vital capacity (SVC). Safety and tolerability were also assessed..

次要终点包括生活质量患者报告的结果评估，总生存率和呼吸功能（通过慢肺活量（SVC）测量）。还评估了安全性和耐受性。。

European participants who completed the 48-week trial had the option to enroll in an open-label extension (OLE) phase. During this phase, all participants receive AMX0035, and continued safety and efficacy measures will be assessed.

完成48周试验的欧洲参与者可以选择参加开放标签扩展（OLE）阶段。在此阶段，所有参与者均接受AMX0035，并将评估持续的安全性和有效性措施。

About the CENTAUR Trial

关于半人马座试验

CENTAUR was a multicenter Phase 2 clinical trial in 137 participants with ALS encompassing a 6-month randomized, placebo-controlled phase and an open-label long-term follow-up phase. The trial met its primary efficacy endpoint of reducing functional decline as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R)..

CENTAUR是一项多中心2期临床试验，共有137名ALS患者参加，包括6个月的随机，安慰剂对照阶段和开放标签的长期随访阶段。该试验达到了通过ALS功能评定量表修订版（ALSFRS-R）测量的减少功能衰退的主要疗效终点。。

Overall, reported rates of adverse events and discontinuations were similar between AMX0035 and placebo groups during the 24-week randomized phase; however, gastrointestinal events occurred with greater frequency (≥2%) in the AMX0035 group. Detailed data from CENTAUR is published in the New England Journal of Medicine (NEJM) and Muscle & Nerve..

总体而言，AMX0035组和安慰剂组在24周随机阶段报告的不良事件和停药率相似；然而，AMX0035组发生胃肠道事件的频率更高（≥2%）。半人马座的详细数据发表在《新英格兰医学杂志》（NEJM）和《肌肉与神经》上。。

The CENTAUR trial was funded, in part, by the ALS ACT grant and the ALS Ice Bucket Challenge, and was supported by The ALS Association, ALS Finding a Cure (a program of The Leandro P. Rizzuto Foundation), the Northeast ALS Consortium, and the Sean M. Healey & AMG Center for ALS at Mass General.

半人马座试验部分由ALS法案拨款和ALS冰桶挑战资助，并得到了ALS协会，ALS寻找治愈方法（Leandro P.Rizzuto基金会的一个项目），东北ALS财团以及Mass General的Sean M.Healey＆AMG ALS中心的支持。

About AMX0114

关于AMX0114

AMX0114 is an antisense oligonucleotide designed to target the gene encoding calpain-2, a key contributor to the axonal (Wallerian) degeneration pathway. Axonal degeneration has been recognized as an important early contributor to the clinical presentation and pathogenesis of ALS and other neurodegenerative diseases.

AMX0114是一种反义寡核苷酸，旨在靶向编码calpain-2的基因，calpain-2是轴突（Wallerian）变性途径的关键贡献者。轴突变性已被认为是ALS和其他神经退行性疾病的临床表现和发病机制的重要早期贡献者。

Calpain-2 has been implicated in the pathogenesis of ALS based on findings of elevated levels of calpain-2 and its cleavage products in postmortem ALS tissue, therapeutic benefit of calpain-2 modulation in animal models of ALS, and the role of calpain-2 in cleaving neurofilament, a broadly researched biomarker in ALS.

基于死后ALS组织中钙蛋白酶-2及其裂解产物水平升高的发现，钙蛋白酶-2调节在ALS动物模型中的治疗益处以及钙蛋白酶-2在切割神经丝中的作用，钙蛋白酶-2与ALS的发病机制有关，神经丝是ALS中广泛研究的生物标志物。

Preclinical studies completed to date have shown that AMX0114 achieves potent, dose-dependent, and durable knockdown of CAPN2 mRNA expression and calpain-2 protein levels in human motor neurons. Moreover, in preclinical efficacy studies, treatment with AMX0114 reduced extracellular neurofilament light chain levels following neurotoxic insult in iPSC-derived human motor neurons, and improved survival of iPSC-derived human motor neurons harboring ALS-linked, pathogenic TDP-43 mutations..

迄今为止完成的临床前研究表明，AMX0114在人类运动神经元中实现了CAPN2 mRNA表达和钙蛋白酶-2蛋白水平的有效，剂量依赖性和持久的敲低。此外，在临床前疗效研究中，AMX0114治疗降低了iPSC衍生的人类运动神经元神经毒性损伤后的细胞外神经丝轻链水平，并改善了携带ALS相关的致病性TDP-43突变的iPSC衍生的人类运动神经元的存活率。。

About ALS

关于ALS

Amyotrophic lateral sclerosis (ALS, also known as motor neuron disease) is a relentlessly progressive and fatal neurodegenerative disorder caused by motor neuron death in the brain and spinal cord. Motor neuron loss in ALS leads to deteriorating muscle function, the inability to move and speak, respiratory paralysis, and eventually, death.

肌萎缩侧索硬化症（ALS，也称为运动神经元疾病）是一种无情的进行性致命神经退行性疾病，由大脑和脊髓中的运动神经元死亡引起。ALS中运动神经元的丢失会导致肌肉功能恶化，无法移动和说话，呼吸麻痹，最终导致死亡。

More than 90% of people with ALS have sporadic disease, showing no clear family history. ALS affects around 30,000 people in the U.S., and more than 30,000 people are estimated to be living with ALS in Europe (European Union and United Kingdom). People living with ALS have a median survival of approximately two years from diagnosis..

超过90%的ALS患者患有散发性疾病，没有明确的家族史。ALS影响美国约30000人，估计欧洲（欧盟和英国）有30000多人患有ALS。ALS患者的中位生存期约为两年。。

About HELIOS

关于HELIOS

The HELIOS trial (NCT05676034) is a 12-participant, open-label proof of biology, Phase 2 trial designed to study the effect of AMX0035 on safety and tolerability, and various measures of endocrinological, neurological, and ophthalmologic function in adult participants living with Wolfram syndrome (WS)..

HELIOS试验（NCT05676034）是一项12名参与者的开放标签生物学证明2期试验，旨在研究AMX0035对Wolfram综合征（WS）成年参与者的安全性和耐受性以及内分泌，神经和眼科功能的各种测量。。

About Wolfram Syndrome

关于Wolfram综合征

Wolfram syndrome (WS) is an autosomal recessive neurodegenerative disease characterized by childhood-onset diabetes, optic nerve atrophy, and neurodegeneration. Common manifestations of WS include diabetes mellitus, optic nerve atrophy, central diabetes insipidus, sensorineural deafness, neurogenic bladder, and progressive neurologic difficulties.

Wolfram综合征（WS）是一种常染色体隐性神经退行性疾病，其特征是儿童期糖尿病，视神经萎缩和神经变性。WS的常见表现包括糖尿病，视神经萎缩，中枢性尿崩症，感音神经性耳聋，神经源性膀胱和进行性神经系统疾病。

Genetic and experimental evidence suggest that endoplasmic reticulum (ER) dysfunction is a critical pathogenic component of WS. The prognosis of WS is poor, and many people with the disease die prematurely with severe neurological disabilities..

遗传和实验证据表明，内质网（ER）功能障碍是WS的关键致病成分。WS的预后很差，许多患有该病的人过早死亡，并伴有严重的神经功能障碍。。

About the ORION Trial

关于猎户座试验

The Phase 3 ORION trial (NCT06122662) is a global, randomized, double-blind, placebo-controlled Phase 3 clinical trial designed to assess the efficacy, safety, and tolerability of AMX0035 compared to placebo in people living with progressive supranuclear palsy (PSP). The ORION Phase 3 trial was designed and planned in collaboration with key global academic leaders, people living with PSP and their caregivers, and industry advocacy organizations..

3期ORION试验（NCT06122662）是一项全球性，随机，双盲，安慰剂对照的3期临床试验，旨在评估AMX0035与安慰剂相比在进行性核上性麻痹（PSP）患者中的疗效，安全性和耐受性。猎户座3期试验是与全球主要学术领袖、PSP患者及其护理人员以及行业倡导组织合作设计和计划的。。

About PSP

关于PSP

Progressive supranuclear palsy (PSP) is a sporadic, rare and adult-onset neurodegenerative disorder that affects walking and balance, eye movement, swallowing, and speech. People living with PSP have a life expectancy of six to eight years after initial diagnosis, and its epidemiology is similar to that of amyotrophic lateral sclerosis (ALS).

进行性核上性麻痹（PSP）是一种散发性，罕见的成人发作的神经退行性疾病，会影响行走和平衡，眼球运动，吞咽和言语。患有PSP的人在初步诊断后的预期寿命为6至8年，其流行病学与肌萎缩侧索硬化症（ALS）相似。

PSP typically begins in late-middle age and rapidly progresses over time. The disease affects approximately seven in 100,000 people worldwide, and there are currently no disease-modifying therapies approved for the treatment of PSP..

PSP通常始于中年晚期，并随着时间的推移迅速发展。该疾病影响全球约100000人中的7人，目前还没有批准用于治疗PSP的疾病缓解疗法。。

PSP is characterized by abnormal tau inclusions and is consequently also known as a tauopathy. Similar to other neurodegenerative diseases, pathophysiologic changes underlying PSP are multifactorial with several genetic and environmental factors likely contributing to tau dysfunction and aggregation..

PSP的特征是异常的tau包涵体，因此也称为tau蛋白病。与其他神经退行性疾病类似，PSP的病理生理变化是多因素的，有几种遗传和环境因素可能导致tau功能障碍和聚集。。

Multiple pathways, including genetic mutations, endoplasmic reticulum (ER) stress and the activation of unfolded protein response, mitochondrial dysfunction, and neuroinflammation have been implicated as contributors to tau dysfunction and aggregation.

多种途径，包括基因突变，内质网（ER）应激和未折叠蛋白反应的激活，线粒体功能障碍和神经炎症，已被认为是tau功能障碍和聚集的原因。

About AMX0035 / RELYVRIO® / ALBRIOZA™

关于AMX0035/RELYVRIO®/ALBRIOZA™

AMX0035 is an oral, fixed-dose combination of sodium phenylbutyrate and taurursodiol (known as ursodoxicoltaurine outside of the U.S.). It is approved as RELYVRIO® to treat amyotrophic lateral sclerosis (ALS) in adults in the U.S. and approved with conditions as ALBRIOZA™ for the treatment of ALS in Canada.

AMX0035是苯丁酸钠和牛磺熊去氧醇（在美国以外称为熊去氧胆酸）的口服固定剂量组合。它被批准为RELYVRIO®用于治疗美国成年人的肌萎缩侧索硬化症（ALS），并在加拿大被批准为ALBRIOZA™用于治疗ALS。

AMX0035 is being studied for the potential treatment of other neurodegenerative diseases, and Amylyx is exploring its treatment in other populations and regions. The formulation of RELYVRIO, ALBRIOZA, and AMX0035 is identical..

AMX0035正在研究其他神经退行性疾病的潜在治疗方法，Amylyx正在其他人群和地区探索其治疗方法。RELYVRIO，ALBRIOZA和AMX0035的配方相同。。

RELYVRIO® (sodium phenylbutyrate and taurursodiol) Safety Information for United States

RELYVRIO®（苯丁酸钠和牛磺酸钠）美国安全信息

WARNINGS AND PRECAUTIONS

警告和注意事项

Risk in Patients with Enterohepatic Circulation Disorders, Pancreatic Disorders, or Intestinal Disorders

肠肝循环障碍、胰腺疾病或肠道疾病患者的风险

RELYVRIO contains taurursodiol, which is a bile acid. In patients with disorders that interfere with bile acid circulation, there may be an increased risk for worsening diarrhea, and patients should be monitored appropriately for this adverse reaction. Pancreatic insufficiency, intestinal malabsorption, or intestinal diseases that may alter the concentration of bile acids may also lead to decreased absorption of either of the components of RELYVRIO.

RELYVRIO含有牛磺酸，这是一种胆汁酸。对于患有干扰胆汁酸循环的疾病的患者，腹泻恶化的风险可能会增加，应适当监测患者的这种不良反应。胰腺功能不全，肠道吸收不良或可能改变胆汁酸浓度的肠道疾病也可能导致RELYVRIO任一成分的吸收减少。

Because different enterohepatic circulation, pancreatic, and intestinal disorders have varying degrees of severity, consider consulting with a specialist. Patients with disorders of enterohepatic circulation (e.g., biliary infection, active cholecystitis), severe pancreatic disorders (e.g., pancreatitis), and intestinal disorders that may alter concentrations of bile acids (e.g., ileal resection, regional ileitis) were excluded from the study; therefore, there is no clinical experience in these conditions..

由于不同的肝肠循环，胰腺和肠道疾病的严重程度不同，请考虑咨询专家。患有肠肝循环障碍（例如胆道感染，活动性胆囊炎），严重胰腺疾病（例如胰腺炎）和可能改变胆汁酸浓度的肠道疾病（例如回肠切除术，局部回肠炎）的患者被排除在研究之外；因此，在这些情况下没有临床经验。。

Use in Patients Sensitive to High Sodium Intake

用于对高钠摄入敏感的患者

RELYVRIO has a high salt content. Each initial daily dosage of 1 packet contains 464 mg of sodium; each maintenance dosage of 2 packets daily contains 928 mg of sodium. In patients sensitive to salt intake (e.g., those with heart failure, hypertension, or renal impairment), consider the amount of daily sodium intake in each dose of RELYVRIO and monitor appropriately..

RELYVRIO的含盐量很高。每包初始每日剂量含464毫克钠；每天2包的每次维持剂量含有928毫克钠。对于对盐摄入敏感的患者（例如心力衰竭，高血压或肾功能不全的患者），考虑每剂RELYVRIO的每日钠摄入量并进行适当监测。。

ADVERSE REACTIONS

不良反应

The most common adverse reactions (at least 15% and at least 5% greater than placebo) with RELYVRIO were diarrhea, abdominal pain, nausea, and upper respiratory tract infection. Gastrointestinal-related adverse reactions occurred throughout the study but were more frequent during the first 3 weeks of treatment..

RELYVRIO最常见的不良反应（比安慰剂至少高15%和至少5%）是腹泻，腹痛，恶心和上呼吸道感染。在整个研究过程中发生了与胃肠道相关的不良反应，但在治疗的前3周内更为频繁。。

Please click here for RELYVRIO Full U.S. Prescribing Information.

请单击此处获取RELYVRIO美国处方的完整信息。

About Amylyx Pharmaceuticals

关于Amylyx Pharmaceuticals

Amylyx Pharmaceuticals, Inc. is committed to supporting and creating more moments for the neurodegenerative disease community through the discovery and development of innovative new treatments. Amylyx is headquartered in Cambridge, Massachusetts and has operations in Canada, EMEA, and Japan. For more information, visit amylyx.com and follow us on LinkedIn and X, (formerly Twitter).

Amylyx Pharmaceuticals，Inc.致力于通过发现和开发创新的新疗法，为神经退行性疾病社区提供支持和创造更多时刻。Amylyx总部位于马萨诸塞州剑桥市，在加拿大、欧洲、中东和非洲以及日本都有业务。有关更多信息，请访问amylyx.com，并在LinkedIn和X（以前的Twitter）上关注我们。

For investors, please visit investors.amylyx.com..

对于投资者，请访问investors.amylyx.com。。

Forward-Looking Statements

前瞻性声明

Statements contained in this press release and related comments in our earnings conference call regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements.

本新闻稿中包含的声明以及我们的收益电话会议中有关非历史事实的相关评论均为1995年《私人证券诉讼改革法案》修订版所指的“前瞻性声明”。由于此类报表存在风险和不确定性，因此实际结果可能与此类前瞻性报表明示或暗示的结果存在重大差异。

Such statements include, but are not limited to, Amylyx’ expectations regarding: interactions with regulatory authorities; the continued availability of RELYVRIO/ALBRIOZA for people living with ALS while such interactions are ongoing; the pausing of promotion of RELYVRIO/ALBRIOZA; pathways for continued access for patients if RELYVRIO/ALBRIOZA are withdrawn from the market; the possibility for Amylyx to voluntarily withdraw RELYVRIO/ALBRIOZA from the market; the continued evaluation of AMX0035 in other neurodegenerative diseases, including the timing for expected data readouts in the ORION and HELIOS studies; and the evidence of biological activity of AMX0035 in Wolfram syndrome.

此类声明包括但不限于Amylyx对以下方面的期望：与监管机构的互动；在这种互动正在进行的情况下，RELYVRIO/ALBRIOZA继续为ALS患者提供；停止推广RELYVRIO/ALBRIOZA；如果RELYVRIO/ALBRIOZA退出市场，患者继续进入的途径；Amylyx自愿将RELYVRIO/ALBRIOZA退出市场的可能性；AMX0035在其他神经退行性疾病中的持续评估，包括ORION和HELIOS研究中预期数据读数的时间；以及AMX0035在Wolfram综合征中具有生物活性的证据。

Any forward-looking statements in this press release and related comments in the Company's conference call are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements.

本新闻稿中的任何前瞻性声明和公司电话会议中的相关评论均基于管理层目前对未来事件的预期，并受到许多风险和不确定性的影响，这些风险和不确定性可能导致实际结果与此类前瞻性声明中所述或暗示的结果产生重大不利影响。

Risks that contribute to the uncertain nature of the forward-looking statements include the risks and uncertainties set forth in Amylyx’ United States Securities and Exchange Commission (SEC) filings, including Amylyx’ Annual Report on Form 10-K for the year ended December 31, 2023, and subsequent filings with t.

导致前瞻性报表不确定性的风险包括Amylyx在美国证券交易委员会（SEC）的文件中规定的风险和不确定性，包括Amylyx在表格10-K中截至2023年12月31日的年度报告，以及随后向t。