BERLIN, GERMANY / ACCESSWIRE / April 23, 2024 / Berlin Cures, a pioneering clinical-stage biotechnology company, today announced the successful completion of patient screening for its pan-European Phase II trial of BC 007 (Rovunaptabin), a novel therapeutic candidate for the treatment of Long COVID.

德国柏林/ACCESSWIRE/2024年4月23日/柏林Cures，一家开创性的临床阶段生物技术公司，今天宣布成功完成其BC 007（Rovunaptabin）泛欧II期试验的患者筛查，这是一种新型治疗候选药物治疗长COVID。

The study has now recruited its target number of participants, marking a significant step forward in the company's pursuit to help millions of people suffering from Long COVID. The trial is progressing rapidly into its next clinical stages and remains firmly on schedule, with first results anticipated by autumn 2024..

该研究现已招募了目标人数的参与者，这标志着该公司在帮助数百万长期新型冠状病毒感染者方面迈出了重要的一步。该试验正在迅速进入下一个临床阶段，并严格按计划进行，预计将于2024年秋季取得初步结果。。

More than 114 patients across 14 trial centers in Finland, Germany, Austria, Switzerland, and Spain have now been enrolled. With the completion of the screening process, patients are asked to refrain from submitting further applications, as all available places in the study have been filled.

芬兰、德国、奥地利、瑞士和西班牙14个试验中心的114多名患者现已入选。随着筛查过程的完成，患者被要求不再提交进一步的申请，因为研究中所有可用的名额都已填满。

Oliver von Stein, CEO of Berlin Cures , expressed his satisfaction with the trial's progress: 'The completion of recruitment in such a short period of time demonstrates the great need for an effective therapy for Long COVID. This achievement reflects our commitment to rigorous scientific processes and our dedication to developing a treatment that can significantly improve patient outcomes.

Berlin Cures首席执行官奥利弗·冯·斯坦（Oliver von Stein）对试验的进展表示满意：“在如此短的时间内完成招募工作，表明迫切需要对长期新型冠状病毒进行有效治疗。这一成就反映了我们对严格科学过程的承诺，以及我们致力于开发可以显着改善患者预后的治疗方法。

We look forward to the forthcoming results, which we believe will bring us closer to a major breakthrough in the fight against Long COVID.'.

我们期待即将取得的结果，我们相信这将使我们在抗击长冠状病毒方面取得重大突破。”。

Berlin Cures is at the forefront of developing innovative aptamer-based drugs to neutralize pathogenic functional autoantibodies (fAABs) that contribute to a variety of autoimmune diseases, including Long COVID, heart failure, glaucoma, ME/CFS and many more. The drug candidate BC 007 targets these harmful fAABs, which are believed to play a critical role in the symptoms associated with Long COVID..

Berlin Cures在开发基于适体的创新药物以中和致病性功能性自身抗体（FAAb）方面处于领先地位，这些抗体会导致多种自身免疫性疾病，包括长冠状病毒，心力衰竭，青光眼，ME/CFS等。候选药物BC 007针对这些有害的FAAb，据信这些FAAb在与长COVID相关的症状中起关键作用。。

With the trial fully recruited, Berlin Cures is actively preparing for the subsequent Phase III study, which will be essential for gaining regulatory approval and bringing BC 007 to market. The company is currently actively seeking funding partners to initiate Phase III as soon as possible following the successful completion of Phase II..

随着试验的全面招募，Berlin Cures正在积极准备随后的III期研究，这对于获得监管部门的批准并将BC 007推向市场至关重要。公司目前正在积极寻找资金合作伙伴，以便在第二阶段成功完成后尽快启动第三阶段。。

About Berlin Cures:

关于柏林治疗：

The Berlin Cures team has dedicated over two decades to the research of functional autoantibodies (fAABs) and has successfully identified a molecule capable of effectively neutralizing these. Promising preclinical results have been observed for BC 007. In a recently completed Phase IIa trial with patients with chronic heart failure, BC 007 demonstrated long-term autoantibody neutralization after a single dose resulting in significant improvement in cardiac function, with no spontaneous disappearance of autoantibodies in untreated patients.

柏林Cures团队致力于功能性自身抗体（FAAb）的研究超过二十年，并成功鉴定出能够有效中和这些抗体的分子。BC 007已经观察到有希望的临床前结果。在最近完成的一项针对慢性心力衰竭患者的IIa期临床试验中，BC 007在单次剂量后表现出长期的自身抗体中和作用，导致心脏功能显着改善，未经治疗的患者自身抗体没有自发消失。

Its potential as an effective therapy for Long COVID was realized when tests on sera from Long COVID patients proved positive for fAABs, supported by clinical observations in four case studies. By addressing the underlying cause of fAAB-associated diseases with this unique biotechnology, Berlin Cures emerges as one of the pioneering entities committed to addressing this critical issue at its core..

当对来自长COVID患者的血清进行的测试证明FAAb呈阳性时，它作为长COVID的有效疗法的潜力得以实现，这得到了四个案例研究的临床观察的支持。通过利用这种独特的生物技术解决与fAAB相关的疾病的根本原因，Berlin Cures成为致力于解决这一关键问题的先驱实体之一。。

Since June 2023, Berlin Cures has been absolving a Phase II clinical trial with BC 007 in the indication Long COVID, an acute and escalating global health problem, to obtain meaningful and robust results on efficacy and tolerability of BC 007 with patients suffering from Long COVID.

自2023年6月以来，Berlin Cures一直在免除BC 007在长期新型冠状病毒（一种急性且不断升级的全球健康问题）适应症中的II期临床试验，以获得BC 007对患有长期新型冠状病毒的患者的疗效和耐受性的有意义且有力的结果。