Berlin Cures takes next step in battle against Long COVID

Collaboration with Uniklinikum Erlangen as 5th German research center

Berlin, Germany, 10 October 2023

Berlin Cures, a biotechnology firm specializing in the neutralization of functional autoantibodies (fAABs), is extending its collaboration with Uniklinikum Erlangen in the fight against Long COVID. As of 1 October 2023, Uniklinikum Erlangen, a recognized Long COVID research center, is participating in Berlin Cures' approval-relevant Phase II clinical trial (trial name: BLOC; placebo-controlled, 3 arms with 114 patients total), making it the fifth actively recruiting trial center in Germany, with more anticipated to follow.

This partnership represents a significant step forward in the development of BC 007, Berlin Cures’ leading drug candidate for treating Long COVID and other autoimmune diseases. The compound specifically targets and neutralizes harmful fAABs, representing a potential therapeutic strategy for various diseases associated with functional autoantibodies. As an accredited research center for Long COVID, Uniklinikum Erlangen will help Berlin Cures compile significant data on the efficacy and safety of BC 007 for patients with Long COVID. A successful completion will create a pathway to a comprehensive Phase III trial, essential for BC 007’s approval. Berlin Cures anticipates initial results from the Phase II trial in 2024.

Uniklinikum Erlangen's involvement in the Phase II trial BLOC is only one part of the collaboration. In addition, as of 1 October 2023 Berlin Cures is providing Uniklinikum Erlangen’s with BC 007 to conduct its own Phase II clinical trial, named reCOVer, with 30 patients. This initiative follows on from Uniklinikum Erlangen’s earlier Long COVID trials, in which BC 007 was used to neutralize fAABs. The independent study, backed by the German Federal Ministry of Education and Research (BMBF), will allow Uniklinikum Erlangen to continue its research into the molecular mechanisms underlying Long COVID to further advance the understanding of this complex disease.

Oliver von Stein, CEO of Berlin Cures, expressed, "We are delighted to have Uniklinikum Erlangen, and its esteemed researchers and medical professionals, join us in our Phase II clinical trial BLOC. With their extensive experience and a substantial pool of potential study participants we can accelerate the discovery of a definitive treatment for Long COVID.”

PD Dr. Dr. Bettina Hohberger of Uniklinikum Erlangen and lead investigator of the reCOVer study stated, "After witnessing the initial positive outcomes with the BC 007 aptamer in 2021, we are excited to conduct the BMBF-supported investigator-initiated study, reCOVer. This study aims to produce preliminary data on the action mechanism of functional autoantibodies and includes our independent Phase II clinical trial with BC 007 in Erlangen. Additionally, we are thrilled to be part of Berlin Cures' Phase II clinical trial, BLOC.”

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. It was found effective in fAAB-positive healthy volunteers during the Phase I study and in heart failure patients in a Phase IIa study. Its potential against Long COVID is indicated by lab data generated using sera from Long COVID patients, and four case studies. By potentially tackling the root cause of fAAB-associated diseases, this platform biotechnology signifies a pioneering approach in therapeutics. 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 conducting a Phase II clinical study of BC 007 for Long COVID, an acute and rapidly escalating global health issue. The study aims to provide meaningful and robust results regarding the efficacy and tolerability of BC 007 in patients suffering from Long COVID.

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