Recruitment completed: Berlin Cures achieves key milestone in BC 007 Phase II Trial for treatment of Long COVID

Berlin, Germany, 23 April 2024

Berlin Cures, a pioneering clinical-stage biotechnology company, today announced the successful completion of patient recruitment for its pan-European Phase II trial of BC 007 (Rovunaptabin), a novel therapeutic candidate for the treatment of Long 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.

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

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

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.

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.

About Berlin Cures:
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. 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.

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.

FGS Global

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