– Company appoints David Grainger, Ph.D., Chairman of Development

公司任命大卫·格兰杰博士为发展主席

and

和

Meg Fitzgerald

梅格·菲茨杰拉德

, J.D., Chief Legal Officer –

，法学博士，首席法律官 –

– Expansion advances clinical development of Rivus's portfolio of

– 扩展推进了Rivus产品组合的临床开发

novel therapies for obesity and its continuum of cardiometabolic diseases –

肥胖及其连续的心脏代谢疾病的新型疗法 –

CHARLOTTESVILLE, Va. and

夏洛茨维尔，弗吉尼亚州和

SOUTH SAN FRANCISCO, Calif.

加利福尼亚州南旧金山

,

，

April 10, 2025

2025年4月10日

/PRNewswire/ -- Rivus Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company dedicated to treating cardiometabolic diseases driven by obesity, today announced the expansion of its leadership team with the appointments of

/PRNewswire/ -- Rivus Pharmaceuticals, Inc.是一家致力于治疗由肥胖引发的心脏代谢疾病的临床阶段生物制药公司，今天宣布扩大其领导团队，并任命了

David Grainger

大卫·格兰杰

, Ph.D., as Chairman of Development and

，博士，担任发展与

Meg Fitzgerald

梅格·菲茨杰拉德

, J.D., as Chief Legal Officer. Additionally, the company is opening a

，法学博士，担任首席法律顾问。此外，该公司还开设了

South San Francisco

南旧金山

office where Rivus will continue to expand and scale in

办公室，里维斯将继续在其中扩展和发展规模

California

加利福尼亚州

.

。

'We are thrilled to strengthen our management team with the addition of David, who has extensive expertise in drug discovery and development, and Meg, who has more than 20 years of legal experience in the biopharmaceutical industry,' said

“我们非常高兴能够加强我们的管理团队，新增大卫和梅格两位成员。大卫在药物发现和开发方面拥有丰富的专业知识，梅格则在生物制药行业拥有超过20年的法律经验。”

Jayson Dallas

杰森·达拉斯

, M.D., Chief Executive Officer. 'Together with our Bay Area team's move into dedicated office space in the biotech hub of

，医学博士，首席执行官。“我们湾区团队搬迁至生物技术中心的专用办公空间，标志着公司发展的重要一步。

South San Francisco

南旧金山

, we are well positioned to drive forward the clinical development of our promising pipeline of controlled metabolic accelerators (CMAs) to treat obesity and obesity-related metabolic disorders.'

“我们有能力推动我们有前景的控制代谢加速器（CMAs）管线的临床开发，以治疗肥胖和与肥胖相关的代谢紊乱。”

The appointments of Dr. Grainger and Ms. Fitzgerald will accelerate Rivus's growth as it builds on positive Phase 2a data reinforcing the potential of the new class of medicines the company has pioneered. Dr. Grainger will oversee the strategy, design and implementation of the clinical development for Rivus' pipeline of CMA drug candidates, including the company's lead investigational candidate, HU6.

格兰杰博士和菲茨杰拉德女士的任命将加速Rivus的增长，因为该公司在积极的2a期数据基础上继续发展，进一步巩固了其开创的一类新药物的潜力。格兰杰博士将负责监督Rivus的CMA候选药物管线的临床开发战略、设计和实施，包括该公司的主要研究候选药物HU6。

Ms. Fitzgerald will provide strategic legal guidance aligned with the company's goals and ensure compliance with regulatory bodies, overseeing intellectual property, and managing legal risks..

菲茨杰拉德女士将提供与公司目标一致的战略法律指导，确保遵守监管机构的规定，监督知识产权，并管理法律风险。

'In my 30 plus years in the biopharma industry, I have dedicated my career to advancing medicines that will bring true innovation to patients,' said Dr. Grainger. 'This is exactly why I have joined Rivus. I strongly believe that CMAs have the unique potential to transform the way we approach obesity and related cardiometabolic diseases and address widely acknowledged challenges with current therapeutic options.

“在我从事生物制药行业30多年的职业生涯中，我始终致力于推进能够为患者带来真正创新的药物，”格兰杰博士说道。“这正是我加入Rivus的原因。我坚信，CMAs有独特的潜力能够改变我们应对肥胖和相关心代谢疾病的方式，并解决当前治疗方案中公认的挑战。”

I have partnered with the Rivus team in an advisory capacity for several years and look forward to working more closely with them as we approach the imminent readout of our Phase .

我以顾问的身份与Rivus团队合作了多年，随着我们即将迎来第一阶段的成果，我期待与他们更加紧密地合作。

2b

2b

M-ACCEL study in MASH and advance HU6 into the next pivotal phase of development.'

M-ACCEL在MASH中的研究，并将HU6推进到下一个关键开发阶段。

Dr. Grainger has served as an advisor to Rivus's Board of Directors since 2019. He is a co-founder and partner at Medicxi, one of

自2019年以来，格兰杰博士一直担任Rivus董事会的顾问。他是Medicxi的联合创始人和合伙人之一。

Europe's

欧洲的

largest life sciences venture capital groups, where he served as Chief Scientific Advisor and Venture Advisor and was a director of more than a dozen biotech companies in the UK and U.S. He previously served as Chief Innovation Officer at Centessa Pharmaceuticals, where he oversaw research across Centessa's pipeline of 16 programs ranging from discovery to Phase 3 clinical trials.

最大的生命科学风险投资集团，他曾担任首席科学顾问和风险顾问，并在英国和美国的十几家生物技术公司担任董事。他之前还曾担任 Centessa Pharmaceuticals 的首席创新官，负责监督 Centessa 旗下涵盖从发现到三期临床试验的 16 个项目的研究工作。

He has founded more than 30 biotech companies, including Functional Therapeutics, (acquired by Boehringer Ingelheim), XO1 (acquired by Janssen Pharmaceuticals) and the out-sourced drug developers Total Scientific and RxCelerate. Dr. Grainger started his career as a Principal Investigator in the Department of Medicine at .

他创立了30多家生物技术公司，包括Functional Therapeutics（被勃林格殷格翰收购）、XO1（被杨森制药收购）以及外包药物开发公司Total Scientific和RxCelerate。Grainger博士在医学系开始了他的职业生涯。

Cambridge University

剑桥大学

in the

在

United Kingdom

英国

, where he led an internationally recognized research group and published more than 80 first author papers in leading journals. Dr. Grainger holds over 150 patents and patent applications and earned an M.A. and Ph.D. in Natural Sciences from the

，他在那里领导了一个国际公认的研究小组，并在顶级期刊上发表了80多篇第一作者论文。格兰杰博士持有150多项专利和专利申请，并获得了自然科学的硕士学位和博士学位从

University of Cambridge

剑桥大学

.

。

'Rivus is at a pivotal point in its journey, and I am excited to join the

“Rivus正处于其发展历程中的关键节点，我非常高兴能够加入

San Francisco

旧金山

-based team as we continue to expand our local Bay Area footprint,' said Ms. Fitzgerald. 'I am energized by the team's upcoming milestones on the horizon, including the anticipated Phase

“基于团队，我们将继续扩大我们在旧金山湾区的本地影响力，”菲茨杰拉德女士说道。“我对团队即将到来的里程碑充满期待，其中包括预期的阶段

2b

2b

M-ACCEL readout, and look forward to helping drive the continued growth of the company as we work to fully realize the potential of our transformative pipeline of CMAs.'

M-ACCEL读数，并期待在我们努力充分实现CMA转型渠道潜力的过程中，帮助推动公司的持续增长。

Prior to joining Rivus, Ms. Fitzgerald was Chief Legal and Compliance Officer at Codexis, Inc., Chief Compliance Officer and General Counsel at Allakos, Inc. and held the role of Privacy Officer and Associate General Counsel at Aimmune Therapeutics, Inc. Previously, she served as Vice President of Corporate Law at ZS Pharma, Inc., where she played a key role in negotiations that resulted in the .

在加入Rivus之前，菲茨杰拉德女士曾担任Codexis, Inc.的首席法律和合规官，Allakos, Inc.的首席合规官和总法律顾问，并在Aimmune Therapeutics, Inc.担任隐私官和副总法律顾问。此前，她还曾在ZS Pharma, Inc.担任公司法副总裁，在促成相关谈判中发挥了关键作用。

$2.7 billion

27亿美元

sale of ZS Pharma to AstraZeneca. Earlier in her career, Ms. Fitzgerald held increasingly senior leadership roles at Genentech, Inc., ultimately serving as Associate General Counsel and Director of Transactional Law. She served as an associate attorney at Pillsbury Winthrop Shaw Pittman and earned a B.A.

ZS制药公司出售给阿斯利康。菲茨杰拉德女士在职业生涯早期曾在基因泰克公司担任过越来越高级的领导职务，最终担任副总法律顾问兼交易法总监。她曾是皮尔斯伯里温思罗普肖皮特曼律师事务所的助理律师，并获得了学士学位。

and an M.A. from .

并获得来自 的硕士学位。

Stanford University

斯坦福大学

and a J.D. from the

以及法学博士（J.D.）学位来自

University of California, Berkeley

加利福尼亚大学伯克利分校

.

。

About Controlled Metabolic Accelerators (CMAs)

关于受控代谢加速器（CMAs）

Rivus is advancing a new class of investigational therapies called Controlled Metabolic Accelerators (CMAs) that have the potential to improve metabolic health for people with obesity and associated metabolic diseases. Rivus' CMAs are oral small molecules in development to increase resting metabolic rate, which results in increased consumption of energy, primarily from fat.

Rivus正在推进一类名为可控代谢加速剂（CMAs）的新型研究性疗法，这类疗法有潜力改善肥胖及相关的代谢疾病患者的代谢健康。Rivus的CMAs是正在开发中的口服小分子，可提高静息代谢率，从而增加能量消耗，主要来源于脂肪。

The loss in fat mass may address multiple cardiometabolic conditions driven by adiposity. CMAs increase metabolism in a manner that is consistent and imperceptible to the patient by leveraging the natural metabolic process of mitochondrial uncoupling. In preclinical studies, mitochondrial uncoupling was shown to account for a significant portion (20% to 50%) of daily energy expenditure.

脂肪量的减少可能解决由肥胖引起的多种心脏代谢状况。CMAs通过利用线粒体解偶联的自然代谢过程，以一种一致且患者无法察觉的方式提高代谢。在临床前研究中，线粒体解偶联被证明占每日能量消耗的显著部分（20%至50%）。

Caloric-restriction strategies, on the other hand, reduce energy input and result in loss of muscle mass as well as fat. Initial data in humans has demonstrated that CMAs provided fat-selective weight loss, improved insulin sensitivity, and significantly reduced oxidative stress and inflammation..

另一方面，热量限制策略减少能量摄入，导致肌肉质量和脂肪的减少。人类的初步数据表明，CMAs 提供了脂肪选择性的减重效果，改善了胰岛素敏感性，并显著降低了氧化应激和炎症。

About HU6

关于HU6

HU6, a novel, oral, once-daily investigational therapy, is Rivus' lead CMA. It is a purposely designed investigational oral small molecule that is intended to be a foundational monotherapy for cardiac, liver, diabetes and obesity indications. HU6 has been demonstrated to promote sustained body fat loss by imperceptibly increasing resting metabolism, which results in fat burn, while preserving muscle mass.

HU6 是 Rivus 公司领先的一种新型、口服、每日一次的 CMA 疗法。它是一种经过特意设计的研究性口服小分子药物，旨在作为心脏、肝脏、糖尿病和肥胖症适应症的基础单药疗法。HU6 已被证明可以通过不易察觉地增加静息代谢来促进持续的体脂减少，从而实现脂肪燃烧，同时保留肌肉质量。

The current clinical development of HU6 is focused on metabolic diseases with the most morbidity and greatest treatment needs: obesity-related heart failure with preserved ejection fraction (HFpEF) and metabolic dysfunction-associated steatohepatitis (MASH)/metabolic dysfunction-associated steatotic liver disease (MASLD).

HU6目前的临床开发重点是发病率最高且治疗需求最大的代谢性疾病：射血分数保留的肥胖相关心力衰竭（HFpEF）以及代谢功能障碍相关的脂肪性肝炎（MASH）/代谢功能障碍相关的脂肪肝病（MASLD）。

To date, more than 400 patients have been treated with HU6 as part of the clinical development program..

截至目前，作为临床开发计划的一部分，已有400多名患者接受了HU6的治疗。

Results of a Phase 2 metabolic study in patients with a high body mass index (BMI) and MASLD showed that once-daily HU6 significantly reduced liver fat content and body weight with no loss of lean muscle mass and improved key markers of systemic inflammation and metabolism.

高体重指数（BMI）和MASLD患者参与的2期代谢研究结果显示，每日一次的HU6显著减少了肝脏脂肪含量和体重，且没有瘦肌肉质量的损失，并改善了系统性炎症和代谢的关键指标。

1

1

HU6 was well tolerated in this trial; side effects were mainly mild or moderate in severity. Results from the Phase 2a HuMAIN study

HU6 在这项试验中耐受性良好；副作用主要为轻度或中度。2a 期 HuMAIN 研究的结果

(ClinicalTrials.gov: NCT05284617

（ClinicalTrials.gov：NCT05284617）

) of HU6 in patients with obesity-related HFpEF showed the trial met its primary endpoint, demonstrating that treatment with HU6 resulted in statistically significant weight loss. The rationale for the use of HU6 in HFpEF and the design of the HuMAIN trial were published in the

）HU6在肥胖相关HFpEF患者中的试验显示，该试验达到了主要终点，证明使用HU6治疗可带来统计学上显著的体重减轻。HU6在HFpEF中应用的理由以及HuMAIN试验的设计已发表在

European Journal of Heart Failure

欧洲心脏衰竭杂志

in

在

June 2024

2024年6月

.

。

2

2

About Rivus Pharmaceuticals

关于Rivus Pharmaceuticals

Rivus Pharmaceuticals, Inc., a leader in mitochondrial biology, is dedicated to improving metabolic health by advancing a new class of investigational therapies called Controlled Metabolic Accelerators (CMAs). Rivus' lead CMA is the investigational small molecule HU6 in clinical development to treat obesity-related heart failure with preserved ejection fraction (HFpEF), metabolic dysfunction associated steatohepatitis (MASH)/metabolic dysfunction-associated steatotic liver disease (MASLD) and Type 2 diabetes.

Rivus制药公司是线粒体生物学领域的领导者，致力于通过推进一类名为可控代谢加速剂（CMA）的新型研究性疗法来改善代谢健康。Rivus的主要CMA是处于临床开发阶段的研究性小分子HU6，用于治疗与肥胖相关的心力衰竭伴射血分数保留（HFpEF）、代谢功能障碍相关脂肪性肝炎（MASH）/代谢功能障碍相关脂肪肝病（MASLD）以及2型糖尿病。

In addition to HU6, Rivus is developing a pipeline of oral small molecule CMAs. For more information, please visit .

除了HU6，Rivus还在开发一系列口服小分子CMA。欲了解更多信息，请访问 。

www.rivuspharma.com

www.rivuspharma.com

.

。

Contact:

联系：

Meredith Mallen

梅雷迪斯·马伦

Real Chemistry

真实化学

mmallen@realchemistry.com

mmallen@realchemistry.com

(516) 987-2313

(516) 987-2313

References

参考文献

Noureddin M, Khan S, Portell F, et al. Safety and efficacy of once-daily HU6 versus placebo in people with non-alcoholic fatty liver disease and high BMI: a randomised, double-blind, placebo-controlled phase 2a trial.

Noureddin M，Khan S，Portell F，等。每日一次HU6对比安慰剂在非酒精性脂肪肝病和高BMI人群中的安全性和有效性：一项随机、双盲、安慰剂对照的2a期试验。

Lancet Gastroenterol Hepatol

柳叶刀胃肠病学和肝病学

. 2023;8(12):1094-1105.

. 2023；8（12）：1094-1105。

Kitzman DW, Lewis GD, Pandey A, et al. A novel controlled metabolic accelerator for the treatment of obesity-related heart failure with preserved ejection fraction: Rationale and design of the Phase 2a HuMAIN trial.

Kitzman DW，Lewis GD，Pandey A，等。一种新型可控代谢加速器用于治疗射血分数保留的肥胖相关心力衰竭：2a期HuMAIN试验的理由与设计。

Eur J Heart Fail

欧洲心脏杂志-心力衰竭

.

。

June 26, 2024

2024年6月26日

.

。

SOURCE Rivus Pharmaceuticals

来源：里维斯制药公司

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