NEEDHAM, Mass.

马萨诸塞州尼德姆

,

，

April 24, 2025

2025年4月24日

/PRNewswire/ -- Stealth BioTherapeutics Inc. (the 'Company' or 'Stealth'), a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel therapies for diseases involving mitochondrial dysfunction, today announced several upcoming presentations at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting, which is being held .

/PRNewswire/ -- 专注于发现、开发和商业化涉及线粒体功能障碍疾病的新疗法的临床阶段生物技术公司Stealth BioTherapeutics Inc.（“公司”或“Stealth”）今天宣布，将在视觉与眼科研究协会（ARVO）年会上进行多项即将展示的报告，该会议正在举行。

May 4-8, 2025

2025年5月4日至8日

, in

，在

Salt Lake City

盐湖城

. These include new data on bevemipretide, the Company's next-generation ocular topical investigational medicine, including protective effects observed in models of dry age-related macular degeneration (AMD) and glaucoma, and preclinical toxicology and exposure data informing the Company's planned Phase 1 study. .

这些数据包括下一代眼部局部用研究药物 bevemipretide 的新数据，该药物在干性年龄相关性黄斑变性 (AMD) 和青光眼模型中观察到的保护作用，以及为公司计划的 1 期研究提供参考的临床前毒理学和暴露数据。

'We are pleased to present compelling new data further supporting the development of bevemipretide eye drops in serious ophthalmic disorders, beginning with dry AMD,' said

“我们很高兴提供强有力的新数据，进一步支持贝韦米肽滴眼液在严重眼科疾病中的开发，首先是干性AMD，”

Reenie McCarthy

里尼·麦卡锡

, CEO of Stealth BioTherapeutics. 'Our goal is to intervene earlier in disease pathology, when bioenergetic mitochondrial deficits implicated in the progressive degeneration and loss of photoreceptors, eventually leading to vision loss, may still be reversible. As the first mitochondria-targeted topical treatment under investigation for its potential to restore mitochondrial structure and function – and ultimately preserve visual function – bevemipretide may offer a more patient-friendly approach to earlier disease intervention.' .

Stealth BioTherapeutics首席执行官表示：“我们的目标是在疾病病理更早的阶段进行干预，此时与光感受器进行性退化和丧失相关的线粒体生物能量缺陷可能仍然可逆。作为首个在研的线粒体靶向局部治疗药物，bevemipretide有潜力恢复线粒体结构和功能，并最终保护视觉功能，这可能为早期疾病干预提供一种更方便患者的途径。”

Stealth's ARVO presentations are as follows:

Stealth的ARVO演讲如下：

Oral

口服

: 'Ocular topical bevemipretide: targeting retinal tissue and preventing RPE cell and photoreceptor loss in a dry age-related macular degeneration (AMD) model'

‘眼部局部用药贝韦米肽：靶向视网膜组织并在干性年龄相关性黄斑变性（AMD）模型中预防视网膜色素上皮细胞和光感受器损失’

In a dry AMD preclinical model, bevemipretide prevented loss of retinal pigment epithelium (RPE) cells and photoreceptors within the retina and reduction of the outer nuclear layer and total retinal thickness, as compared to vehicle.

在干燥型AMD临床前模型中，与对照组相比，贝韦米肽防止了视网膜色素上皮（RPE）细胞和视网膜内光感受器的丢失，并减少了外核层和视网膜总厚度的降低。

Presentation Number: 927

展示编号：927

Presenter:

主持人：

Michael DiMatteo

迈克尔·迪马特奥

, Ph.D., Vice President, Medical Affairs, Ophthalmology, Stealth BioTherapeutics

医学事务副总裁，眼科，Stealth BioTherapeutics

Presentation Time:

演示时间：

Sunday, May 4

5月4日，星期日

at

在

3:45pm - 4:00pm MT

下午3点45分 - 下午4点00分（山地时间）

Location: Ballroom F

地点：舞会厅 F

Session: 'AMD: New drugs, delivery systems, and mechanisms of action I'

会议：‘AMD：新药物、递送系统和作用机制 I’

Poster

海报

: 'Topical bevemipretide (SBT-272) eye drops in development for dry AMD: Phase 1 trial design informed by 13-week GLP study results'

用于干性AMD的局部用药贝韦米肽（SBT-272）滴眼液正在开发中：1期试验设计基于13周GLP研究结果。

Preclinical study results show sustained dose-dependent concentrations in target retinal tissues following topical administration. Safety findings were deemed non-adverse and largely reversible following a four-week recovery period.

临床前研究结果显示，局部给药后目标视网膜组织中持续存在剂量依赖性浓度。安全性观察结果被认为是非不良的，并且在四周恢复期后大部分可逆。

Posterboard Number: B0245

海报板编号：B0245

Presenter:

主持人：

Anthony Abbruscato

安东尼·阿布鲁斯卡托

, Pharm.D., Senior Vice President of Clinical Development, Stealth BioTherapeutics

，药学博士，临床开发高级副总裁，Stealth BioTherapeutics

Presentation Time:

演示时间：

Monday, May 5

5月5日，星期一

at 3:00pm - 4:45pm MT

下午3:00 - 4:45（山地时间）

Location: Poster Hall

地点：海报大厅

Session: 'AMD pathology and preclinical studies'

会议：‘AMD病理学和临床前研究’

Poster

海报

: 'Neuroprotective Effects of Topical Bevemipretide (SBT-272) in a Rodent Model of Glaucoma'

: '局部应用贝韦米肽（SBT-272）在青光眼啮齿动物模型中的神经保护作用'

In a glaucoma preclinical model, bevemipretide prevented degradation of mitochondrial structure and retinal ganglion cell (RGC) axon transport and protected visual function as assessed by optokinetic nystagmus (OKN) reflex.

在青光眼临床前模型中，bevemipretide阻止了线粒体结构和视网膜神经节细胞（RGC）轴突运输的降解，并通过视动性眼球震颤（OKN）反射评估保护了视觉功能。

Posterboard Number: A0445

海报板编号：A0445

Presenter:

主持人：

Nolan R. McGrady

诺兰·R·麦格雷迪

, Ph.D., Associate Basic Scientist,

，博士，副基础科学家，

Vanderbilt University

范德比尔特大学

Medical Center

医疗中心

Presentation Time:

演示时间：

Tuesday, May 6

5月6日，星期二

at

在

1:15pm - 3:00pm MT

下午1:15 - 下午3:00（山地时间）

Location: Poster Hall

地点：海报大厅

Session: 'Glaucoma: Neuroprotection and neurorepair'

会议主题：“青光眼：神经保护与神经修复”

About Dry AMD

关于干性AMD

AMD is the leading cause of blindness, estimated to affect approximately 20 million older Americans.

年龄相关性黄斑变性是致盲的主要原因，预计会影响大约2000万美国老年人。

1

1

Most patients (85% to 90%) suffer from dry AMD, a progressive and irreversible retinal disease leading to loss of vision due to damage and death of photoreceptors.

大多数患者（85%到90%）患有干性AMD，这是一种进行性和不可逆的视网膜疾病，由于光感受器受损和死亡而导致视力丧失。

2

2

Photoreceptors are retinal neurons that depend heavily on mitochondrial bioenergetics to convert light into electrical signals required for normal visual function. Mitochondrial dysfunction, often associated with aging, smoking, obesity, and cardiovascular health, precedes clinical symptoms and increases with AMD disease progression..

感光细胞是视网膜神经元，依赖线粒体生物能量学将光转化为正常视觉功能所需的电信号。线粒体功能障碍常与衰老、吸烟、肥胖和心血管健康相关，在临床症状出现之前就已存在，并随着年龄相关性黄斑变性（AMD）的进展而加重。

3,4,5

3，4，5

Photoreceptor loss, an FDA-approvable endpoint for dry AMD, can be quantified by measuring the thickness between the ellipsoid zone (EZ), a mitochondrial rich layer of the photoreceptors, and retinal pigment epithelium (RPE). Loss of photoreceptors has been shown to precede and predict the loss of visual function in dry AMD. .

光感受器丧失是干性AMD的FDA可批准终点，可以通过测量椭球体带（EZ）（光感受器中富含线粒体的层）与视网膜色素上皮（RPE）之间的厚度来量化。光感受器的丧失已被证明在干性AMD中先于并预测视觉功能的丧失。

About Stealth BioTherapeutics

关于Stealth BioTherapeutics

Our mission is to develop novel therapies to improve the lives of patients living with diseases of mitochondrial dysfunction. Our lead product candidate, elamipretide, is under review for Barth syndrome and in late-stage development for primary mitochondrial myopathy and dry age-related macular degeneration, where we observed a highly protective effect on photoreceptor loss in Phase 2.

我们的使命是开发新型疗法，以改善线粒体功能障碍疾病患者的生活。我们的主要候选产品elamipretide正在接受巴特综合征的审查，并在原发性线粒体肌病和干性年龄相关性黄斑变性的晚期开发阶段，在二期临床中我们观察到其对光感受器损失具有高度保护作用。

We are evaluating a topical ophthalmic formulation of our second-generation clinical-stage candidate, bevemipretide (SBT-272), for dry age-related macular degeneration. We have a deep pipeline of novel compounds under evaluation for rare neurological, cardiac and myopathic diseases. .

我们正在评估第二代临床阶段候选药物贝维普肽（SBT-272）的眼用局部制剂，用于治疗干性年龄相关性黄斑变性。我们拥有一个深厚的新型化合物管线，正针对罕见的神经、心脏和肌病疾病进行评估。

Investor Contact

投资者联系人

Austin Murtagh

奥斯汀·默塔格

Precision AQ

精密AQ

Austin.Murtagh@precisionaq.com

Austin.Murtagh@precisionaq.com

Media Contact

媒体联系人

Anna Stallmann

安娜·施塔尔曼

Anna Stallmann Communications

安娜·施塔尔曼通讯

Anna@annacomms.com

安娜@annacomms.com

1

1

David B. Rein

大卫·B·莱因

et al., 'Prevalence of Age-Related Macular Degeneration in the US in 2019,'

等人，《2019年美国年龄相关性黄斑变性的患病率》，

JAMA Ophthalmology

JAMA眼科

140, no. 12 (

140，第12号（

November 3, 2022

2022年11月3日

): 1202,

): 1202,

https://doi.org/10.1001/jamaophthalmol.2022.4401

https://doi.org/10.1001/jamaophthalmol.2022.4401

.

。

2

2

Neil M. Schultz

尼尔·M·舒尔茨

et al., 'Global Burden of Dry Age-Related Macular Degeneration: A Targeted Literature Review,'

等人，《全球干性年龄相关性黄斑变性的负担：一项针对性的文献综述》，

Clinical Therapeutics

临床治疗学

43, no. 10 (

43，第10号（

October 2021

2021年10月

): 1792–1818,

）：1792–1818，

https://www.clinicaltherapeutics.com/article/S0149-2918(21)00310-6/

https://www.clinicaltherapeutics.com/article/S0149-2918(21)00310-6/

.

。

3

3

Janos Feher

扬诺什·费赫尔

et al., 'Mitochondrial Alterations of Retinal Pigment Epithelium in Age-related Macular Degeneration,'

等人，《年龄相关性黄斑变性中视网膜色素上皮的线粒体改变》，

Neurobiology of Aging

衰老的神经生物学

27, no. 7 (

27，第7号（

June 24, 2005

2005年6月24日

): 983–93,

): 983–93,

https://doi.org/10.1016/j.neurobiolaging.2005.05.012

https://doi.org/10.1016/j.neurobiolaging.2005.05.012

.

。

4

4

Pabalu P. Karunadharma et al., 'Mitochondrial DNA Damage as a Potential Mechanism for Age-Related Macular Degeneration,'

Pabalu P. Karunadharma 等人，《线粒体DNA损伤作为年龄相关性黄斑变性的潜在机制》

Investigative Ophthalmology & Visual Science

眼科与视觉科学调查

51, no. 11 (

51，第11号（

May 26, 2010

2010年5月26日

): 5470,

): 5470,

https://doi.org/10.1167/iovs.10-5429

https://doi.org/10.1167/iovs.10-5429

.

。

5

5

Marcia R. Terluk

玛西亚·R·特鲁克

et al., 'Investigating Mitochondria as a Target for Treating Age-Related Macular Degeneration,'

等人，《将线粒体作为治疗年龄相关性黄斑变性的靶点进行研究》，

Journal of Neuroscience

神经科学期刊

35, no. 18 (

35，第18号（

May 6, 2015

2015年5月6日

): 7304–11,

): 7304–11，

https://doi.org/10.1523/jneurosci.0190-15.2015

https://doi.org/10.1523/jneurosci.0190-15.2015

.

。

SOURCE Stealth BioTherapeutics Inc.

来源：Stealth BioTherapeutics Inc.

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