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柏林治愈BC 007针对长期新冠肺炎:II期试验进展稳定,招募患者超过50%

Berlin Cures' BC 007 Targets Long COVID: Solid Phase II Trial Progress with Over 50% Patient Recruitment

CISION 等信源发布 2024-03-04 21:02

可切换为仅中文


Berlin Cures, a clinical-stage biotechnology firm, advances innovative treatment aimed at combating Long COVID, currently impacting over 100 million people globally.

Berlin Cures是一家临床阶段的生物技术公司,它推进了旨在对抗长期新型冠状病毒的创新治疗,目前全球有1亿多人受到影响。

Over 50% of patients in randomized placebo-controlled Phase-II-trial now recruited; no issues regarding safety observed.

现在招募了超过50%的随机安慰剂对照II期试验患者;没有观察到安全问题。

Berlin Cures innovative platform develops novel aptamer-based drugs to neutralize pathogenic functional autoantibodies, targeting diseases.

柏林治愈创新平台开发了基于适体的新型药物,以中和针对疾病的致病性功能性自身抗体。

BERLIN, March 4, 2024 /PRNewswire/ -- Berlin Cures, a clinical-stage biotechnology company, has reached a significant milestone in its Europe-wide clinical trial for Long COVID, effectively enrolling over 50% of the targeted 114 patients and expanding the study's inclusion criteria. The trial is investigating the efficacy of BC 007, the company's pioneering drug candidate designed to neutralize functional autoantibodies (fAABs), which play a key role in the persistence of Long COVID symptoms..

柏林,2024年3月4日/PRNewswire/--临床阶段生物技术公司柏林治愈公司(BERLIN Cures)在其针对长新型冠状病毒(Long-COVID)的全欧洲临床试验中取得了重要里程碑,有效招募了114名目标患者中的50%以上,并扩大了研究的纳入标准。该试验正在调查BC 007的疗效,该公司的开创性候选药物旨在中和功能性自身抗体(FAAb),这在长期COVID症状的持续存在中起着关键作用。。

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Berlin Cures' BC 007 Targets Long COVID: Solid Phase II Trial Progress with Over 50% Patient Recruitment

Berlin Cures的BC 007针对长期新型冠状病毒:固相II试验进展,患者招募率超过50%

Berlin Cures' BC 007 Targets Long COVID: Solid Phase II Trial Progress with Over 50% Patient Recruitment

Berlin Cures的BC 007针对长期新型冠状病毒:固相II试验进展,患者招募率超过50%

The study is actively progressing across 12 trial centers in Finland, Germany, Austria, Switzerland, and Spain, exemplifying the collaborative effort to address Long COVID, which has developed into a significant global health issue. Progress is strong and another seven centers are set to join soon. Anticipated results in autumn 2024 will pave the way for the next development stage, with Berlin Cures currently seeking additional funding to complete Phase II and initiate the crucial Phase III study necessary for regulatory approval..

这项研究正在芬兰、德国、奥地利、瑞士和西班牙的12个试验中心积极取得进展,这是解决长期新型冠状病毒(Long-COVID)的合作努力的例证,该病毒已发展成为一个重大的全球健康问题。进展强劲,另外七个中心将很快加入。2024年秋季的预期结果将为下一个发展阶段铺平道路,柏林治愈公司目前正在寻求额外资金来完成第二阶段,并启动监管部门批准所需的关键的第三阶段研究。。

'Long COVID is a global health crisis, negatively impacting over 100 million people worldwide, significantly reducing their quality of life and imposing substantial economic and social burdens. It puts immense pressure on our health systems and strains economic resources,' states Oliver von Stein, CEO of Berlin Cures.

“长冠状病毒是一种全球健康危机,对全球一亿多人产生负面影响,大大降低了他们的生活质量,并带来了巨大的经济和社会负担。柏林Cures首席执行官奥利弗·冯·斯坦(OliverVonStein)表示,这给我们的卫生系统带来了巨大压力,并使经济资源紧张。

'If we don't act now, we face spiraling healthcare costs, lost productivity, and widening social gaps. Our united front of clinical centers across Europe marks a pivotal move in confronting the pressing issue of Long COVID.'.

“如果我们现在不采取行动,我们将面临医疗费用不断攀升、生产力下降和社会差距扩大的局面。我们在欧洲各地的临床中心联合战线标志着在应对长期新型冠状病毒的紧迫问题方面迈出了关键的一步。”。

As a biotech company focused on neutralizing fAABs, Berlin Cures stands at the forefront of developing innovative treatments for a variety of autoimmune diseases, including Long COVID, heart failure, glaucoma, and many others. Its drug candidate, BC 007, represents a promising solution by targeting harmful fAABs implicated in a range of autoimmune conditions such as Long COVID.The ongoing Phase II clinical trial in Long COVID seeks to deliver conclusive and reliable results on the drug's effectiveness and safety for patients.

作为一家专注于中和FAAb的生物技术公司,Berlin Cures在开发各种自身免疫性疾病的创新治疗方法方面处于领先地位,包括长冠状病毒,心力衰竭,青光眼等。它的候选药物BC 007通过靶向涉及一系列自身免疫疾病(例如长COVID)的有害FAAb,代表了一种有前途的解决方案。正在进行的Long-COVID II期临床试验旨在为患者提供关于该药物有效性和安全性的结论性和可靠结果。

The company anticipates a positive outcome, which will pave the way to proceed with a larger Phase III study, crucial for BC 007's approval.BC 007 Could Potentially Cure Long COVID for Many Current estimates indicate that functional autoantibodies (fAABs) are detectable in blood tests in about 40% of all Long COVID patients.

该公司预计将取得积极成果,这将为进行更大规模的III期研究铺平道路,这对于BC 007的批准至关重要。BC 007可能治愈长型冠状病毒,因为许多目前的估计表明,在所有长型冠状病毒患者中,约40%的血液检测中可检测到功能性自身抗体(FAAb)。

Functional autoantibodies are a specific type of autoantibody that can develop as an immune response following infections, mistakenly target the body's tissues or cells. This interaction can lead to autoimmune diseases. Unlike normal antibodies that protect against infections, fAABs disrupt normal functions by binding to cell receptors or other proteins, often imitating or blocking natural signals needed for healthy cell functions.

功能性自身抗体是一种特定类型的自身抗体,可在感染后发展为免疫反应,错误地靶向身体的组织或细胞。这种相互作用可能导致自身免疫性疾病。与防止感染的正常抗体不同,FAAb通过与细胞受体或其他蛋白质结合来破坏正常功能,通常模仿或阻断健康细胞功能所需的自然信号。

This disruption can result in a variety of autoimmune diseases, depending on the target of the autoantibodies and the role of the targeted tissue in the body.'The presence of fAABs in such a large portion of patients highlights the potential of BC 007 to combat the underlying cause of Long COVID symptoms in a significant group of affected individuals.

根据自身抗体的靶点和靶组织在体内的作用,这种破坏可能导致多种自身免疫性疾病。”在如此大比例的患者中存在FAAb,突显了BC 007在很大一部分受影响个体中对抗长期新型冠状病毒症状的根本原因的潜力。

We are convinced of BC 007's therapeutic potential and are actively seeking support to prepare for a larger Phase III study,' adds Oliver von Stein. 'O.

奥利弗·冯·斯坦补充道:“我们确信BC 007的治疗潜力,并正在积极寻求支持,为更大规模的III期研究做准备。”O。