BERLIN--(BUSINESS WIRE)--Berlin Cures, a biotechnology company specialized in neutralizing functional autoantibodies (fAABs), is expanding its Phase II clinical trial into a pan-European, multi-center collaboration in the fight against Long COVID. A total of 12 sites in Germany, Austria, Switzerland, Finland and Spain are working to advance clinical research into this escalating global health problem. Additional trial sites in Switzerland, Spain and Germany are expected to soon follow. First results of the Phase II trial are expected in 2024. In the event of positive results, Berlin Cures is aiming for a larger Phase III study, which is a prerequisite for the approval of BC 007.
“We are delighted to have so many clinical institutions across Europe working with us towards transforming our platform technology into a therapeutic solution for millions of patients,” says Oliver von Stein, CEO of Berlin Cures. “As we intensify our efforts on a multinational scale, we’re aiming to provide a solution for Long COVID as well as to redefine the approach to multiple other fAAB-associated diseases such as heart failure or glaucoma. This pan-European collaboration symbolizes a united front against an urgent health crisis and underscores our dedication to innovation and impactful science.”
The expansion of the study to five countries across Europe marks an important step in the multinational approach of Berlin Cures’ Phase II trial BLOC. The study will provide meaningful and robust results on the efficacy and tolerability of the company’s lead drug candidate BC 007 in Long COVID patients.
As a platform technology, BC 007 has the potential to cure different autoimmune diseases by targeting fAABs as their root cause. The compound functions similarly to an antibody, binding and neutralizing harmful fAABs. In Long COVID, a considerable proportion of the diseases are due to the presence of fAABs. Berlin Cures aims to pioneer the development of a treatment based on BC 007 that addresses the core of fAAB-associated diseases, such as Long COVID, heart failure and glaucoma.
Overview of trial site locations:
Germany: 2x Berlin (recruiting), Cologne (recruiting), Münster (recruiting), Erlangen (active, starts recruiting soon)
Austria: 2x Vienna (recruiting)
Switzerland: Zurich (active, starts recruiting soon), Basel to follow soon
Spain: Valencia (recruiting), Pamplona (recruiting) Madrid (active, starts recruiting soon); Malaga and Seville to follow soon
Finland: Helsinki (active, starts recruiting soon)
All recruiting trial sites and participation criteria can be found on this page on clinicaltrials.gov.
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 trial, where it demonstrated long-term autoantibody neutralization after a single dose and significant improvement in cardiac function, with no spontaneous disappearance of autoantibodies in untreated patients. Its potential against Long COVID is indicated by lab data generated using sera from Long COVID patients, and four case studies. By tackling the root 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.