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勃林格殷格翰启动潜在同类首创口服化合物治疗地图样萎缩的II期研究

Boehringer Ingelheim Starts Phase II Study of its Potential First-in-Class Oral Compound as a Treatment for Geographic Atrophy​

Drugs 等信源发布 2025-05-07 05:35

可切换为仅中文


Ingelheim, Germany, May 6, 2025 -- Boehringer Ingelheim today announces the start of the JADE Phase II clinical study (NCT06769048), investigating the efficacy and safety of BI 1584862 as a potential first-in-class treatment for geographic atrophy (GA

德国英格尔海姆,2025年5月6日——勃林格殷格翰今日宣布启动JADE二期临床研究 (NCT06769048),研究BI 1584862作为地理萎缩(GA)潜在的首创新疗法的疗效和安全性。

Geographic atrophy (GA) is an eye disease that can lead to irreversible vision loss.

地理萎缩(GA)是一种可导致不可逆视力丧失的眼病。

It affects more than five million people worldwide, of which more than 40% are considered blind, severely impacting their independence, mental health and quality of life.

它影响着全球超过五百万人,其中超过40%被认为失明,严重损害了他们的独立性、心理健康和生活质量。

GA is an advanced and severe form of age-related macular degeneration (AMD), a chronic and progressive retinal disease.

GA 是年龄相关性黄斑变性 (AMD) 的一种高级且严重的形式,是一种慢性且进展性的视网膜疾病。

There is a high unmet need for treatments that stop or slow disease progression and help people maintain their way of life.

对于能够阻止或减缓疾病进展并帮助人们维持生活方式的治疗方案,存在高度未满足的需求。

BI 1584862, a phospholipid modulator developed by Boehringer Ingelheim, is an investigational compound with the potential to be a first-in-class oral treatment for GA, being explored to preserve patient vision.

BI 1584862 是由勃林格殷格翰开发的一种磷脂调节剂,作为一种研究性化合物,有潜力成为首个用于治疗地理性萎缩(GA)的口服药物,目前正被探索用于保护患者视力。

It is Boehringer Ingelheim’s second eye health asset in GA moving to Phase II, following the advancement of the investigational compound BI 771716.

这是勃林格殷格翰在 GA 领域进入第二阶段的第二个眼科健康资产,此前研究化合物 BI 771716 已取得进展。

BI 771716 ( NCT06722157) is a highly specific antibody fragment designed to optimize penetration through the retinal layers to target the GA pathology. BI 771716 was developed by Boehringer Ingelheim using CDR-Life's proprietary technology. Based on its molecular properties, BI 771716 has the potential to achieve unprecedented efficacy..

BI 771716 ( NCT06722157)是一种高度特异性的抗体片段,旨在优化通过视网膜层的渗透,以靶向GA病理。BI 771716由勃林格殷格翰使用CDR-Life的专有技术开发。基于其分子特性,BI 771716有潜力实现前所未有的疗效。

“Vision loss associated with geographic atrophy profoundly affects the lives of those impacted, particularly older adults, making daily activities more difficult.

“与地理萎缩相关的视力丧失深刻影响着受影响者的生活,特别是老年人,使日常活动更加困难。

The loss of independence has a significant burden for patients, caregivers and society overall.

独立能力的丧失给患者、护理人员以及整个社会带来了沉重的负担。

I’m excited to see that Boehringer Ingelheim is exploring treatment options aimed at reducing the treatment and visit burden for patients and their caregivers,”

“我很高兴看到勃林格殷格翰正在探索旨在减轻患者及其护理人员治疗和就诊负担的治疗方案。”

said Karl Csaky, M.D., Ph.D., Principal Investigator of the Phase II trial and Chief Executive and Medical Officer, Retina Foundation of the Southwest. “An oral treatment could alleviate the burden of existing treatment regimens and offer the opportunity to address both eyes simultaneously in patients with bilaterial disease.”.

西南视网膜基金会二期临床试验的首席研究员、医学博士卡尔·查基(Karl Csaky)表示:“一种口服治疗可以减轻现有治疗方案的负担,并为双侧眼病患者提供同时治疗双眼的机会。”

“At Boehringer Ingelheim, we recognize the need for treatments that address the diverse needs of GA patients and of the medical community. Our commitment is reflected in our Phase II clinical trials investigating two distinct compounds, BI 1584862 and BI 771716, each targeting different pathways. This approach highlights our dedication to providing tailored solutions that support the individual needs of people living with the condition,” said Patrick .

“在勃林格殷格翰,我们认识到需要针对GA患者和医学界的多样化需求提供治疗方案。我们的承诺体现在二期临床试验中研究的两种不同化合物BI 1584862和BI 771716上,每种化合物针对不同的通路。这种方法突显了我们致力于提供量身定制的解决方案,以支持患有该疾病的人们的个性化需求,”帕特里克表示。

Bussfeld

布斯菲尔德

, M.D., Ph.D., Global Head of Medicine, Eye Health at Boehringer Ingelheim. “By exploring multiple avenues, we are seeking to offer more individualized treatment options and, ultimately, improve the quality of life for people living with geographic atrophy.'

医学博士,Boehringer Ingelheim 全球医药部门眼健康负责人。“通过探索多种途径,我们力求提供更加个性化的治疗选择,并最终改善地理性萎缩患者的生活质量。”

The announcement of the start of the two Phase II clinical trials in GA coincides with the Association for Research in Vision and Ophthalmology (ARVO) Annual meeting, where Boehringer Ingelheim is presenting 19 abstracts spanning its diverse Eye Health portfolio that is dedicated to addressing areas of unmet need across retinal conditions.

两项二期临床试验在GA的启动公告恰逢视觉与眼科研究协会 (ARVO) 年会,勃林格殷格翰在会上展示了涵盖其多样化眼健康产品组合的19篇摘要,该组合致力于解决视网膜疾病领域中未满足的需求。

BI 1584862 is an investigational phospholipid modulator compound intended to limit the further growth of GA by targeting inflammation and preserving vascular function. The compound was discovered and developed by Boehringer Ingelheim and is part of its research and development portfolio in retinal conditions..

BI 1584862 是一种研究性磷脂调节化合物,旨在通过靶向炎症和保护血管功能来限制GA的进一步增长。该化合物由勃林格殷格翰发现并开发,是其在视网膜疾病研究与开发组合的一部分。

BI 771716, developed by Boehringer Ingelheim using CDR-Life’s proprietary technology, is a highly specific antibody fragment, possibly enabling an optimized penetration through all retinal layers to the most critical target site driving GA disease pathology. CDR-Life and Boehringer Ingelheim initiated their collaboration and licensing agreement in May 2020.

BI 771716是由勃林格殷格翰使用CDR-Life的专有技术开发的高特异性抗体片段,可能能够优化穿透所有视网膜层,到达驱动GA疾病病理的最关键靶点。CDR-Life和勃林格殷格翰于2020年5月启动了他们的合作和许可协议。

BI 771716 is part of Boehringer Ingelheim’s research and development portfolio in retinal conditions.  .

BI 771716 是勃林格殷格翰在视网膜疾病领域的研发组合的一部分。

Age-related macular degeneration (AMD) is an age-related disease of the central portion of the retina (the macula) which is responsible for high visual acuity that allows for color vision, reading and facial recognition.

年龄相关性黄斑变性 (AMD) 是一种与年龄相关的视网膜中央部分(黄斑)疾病,黄斑负责实现高视觉清晰度,允许进行彩色视觉、阅读和面部识别。

Geographic atrophy (GA) is an advanced and severe form of AMD that progresses slowly but can lead to permanent vision loss.

地理性萎缩(GA)是一种进展缓慢但可能导致永久性视力丧失的晚期严重形式的AMD。

More than 5 million people worldwide suffer from GA, of which more than 40% are legally blind.

全球有超过500万人患有GA,其中超过40%的人被认定为法定盲人。

From age 50 years, the prevalence of GA quadruples every 10 years.

从50岁开始,GA的患病率每10年增加四倍。

Consequently, rising incidences are expected in aging populations.

因此,预计在老龄化人口中发病率会上升。

People with GA experience moderate to severe central vision loss, which can impact daily life activities such as driving, shopping alone, reading, finding street signs and a wide range of social and manual activities that require fine motor control.

患有GA的人会出现中度到重度的中央视力丧失,这可能影响日常活动,如驾驶、独自购物、阅读、寻找路标以及需要精细运动控制的各种社交和手动活动。

These limitations can lead to a loss of independence and social isolation, which in turn can have an impact on mental health, leading to depression, fear and anxiety.

这些限制可能导致独立性丧失和社会孤立,从而反过来对心理健康产生影响,导致抑郁、恐惧和焦虑。

Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry’s top investors in Research and Development, the company focuses on developing innovative therapies in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain.

勃林格殷格翰是一家活跃于人类和动物健康的生物制药公司。作为行业内在研发领域投入最多的公司之一,该公司专注于在未满足医疗需求的高需求领域开发创新疗法。自1885年成立以来,勃林格始终保持独立,并以长远的眼光看待发展,将可持续性贯穿于整个价值链。

More than 54,500 employees serve over 130 markets to build a healthier, more sustainable, and equitable tomorrow. Learn more at www.boehringer-ingelheim.com.

超过54,500名员工服务于130多个市场,共同致力于打造一个更健康、更可持续和更公平的未来。更多信息请访问www.boehringer-ingelheim.com。