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BERLIN, November 23, 2023–(BUSINESS WIRE)–Berlin Cures, a biotechnology company specializing in the neutralization of functional autoantibodies (fAABs), is expanding its Phase II clinical trial as part of a pan-European multicenter collaboration in the fight against long COVID. A total of 12 sites in Germany, Austria, Switzerland, Finland and Spain are being run to advance clinical studies on this developing global health problem. They are expected to soon join more testing sites in Switzerland, Spain, and Germany. First-line results from the Phase II trial are expected in 2024. In case of positive effects, Berlin Cures is a larger Phase III study, which is a prerequisite for the approval of BC 007.
“We are very pleased that so many clinical facilities across Europe are joining us in our platform for generating curative solutions for millions of patients,” says Oliver von Stein, CEO of Berlin Cures. “As we scale our efforts into a multinational scale, our goal is to provide a solution to long COVID and redefine the strategy for other FAAB-related illnesses, such as heart failure or glaucoma. This pan-European collaboration symbolises a united front opposed to a pressing health crisis and underlines our commitment to innovation and impactful science.
The expansion of the study to five countries in Europe marks a milestone in the multinational strategy of the Phase II BLOC trial at Berlin Cures. The study will provide significant and physically potent efficacy and tolerability effects for the company’s lead drug candidate, BC 007, in patients with long COVID.
As a generation platform, BC 007 has the potential to cure other autoimmune ailments by targeting fAABs as a root cause. The compound acts on an antibody, binding to and neutralizing destructive fAABs. In the case of Long COVID, a large proportion of the ailments are due to the presence of fAAB. Berlin Cures aims to pioneer the progression of a remedy based on BC 007 that addresses the core of ailments associated with fAAB, such as Long COVID, heart failure, and glaucoma.
Test Sites Overview:Germany: 2x Berlin (recruitment), Cologne (recruitment), Münster (recruitment), Erlangen (active, start recruiting soon)Austria: 2x Vienna (recruitment)Switzerland: Zurich (active, start recruiting soon), Basel will stay soon Spain: Valencia (recruitment), Pamplona (recruitment) Madrid (active, start recruiting soon); Malaga and Sevilla will soon be left with Finland: Helsinki (active, start recruiting soon)
All recruitment trial sites and participation criteria can be found on this page at Clinicaltrials. gov.
About Berlin:
The Berlin Cures team has spent more than two decades researching functional autoantibodies (fAABs) and has managed to identify a molecule that can neutralize them. Promising preclinical effects have been observed for BC 007. Se has been shown to be effective in healthy fAAB-positive patients. Phase I test volunteers and in patients with central failure in a Phase IIa trial, where it demonstrated long-term neutralization of autoantibodies after a single dose and significant efficacy. Improvement of cardiac function, without spontaneous disappearance of autoantibodies in untreated patients. As opposed to Long COVID, it is indicated through laboratory knowledge generated from sera of patients with Long COVID and through 4 case studies. By addressing the root cause of fAAB-associated diseases through this unique biotechnology, Berlin Cures appears to be one of the pioneering entities committed to combating this critical challenge at its core.
Since June 2023, Berlin Cures has initiated a Phase II clinical trial with BC 007 in the indication of long COVID, an acute and developing global fitness problem, with significant and physically powerful effects on the efficacy and tolerability of BC 007 in patients with long COVID. .
See the businesswire. com edition: https://www. businesswire. com/news/home/20231122420822/en/
Contacts
FGS GlobalE-Mail: berlincures-eu@fgsglobal. com Tel: 41 678 46 03