If biotech Berlin Cures’ larger Phase III study of its Long COVID drug candidate goes ahead, the findings will support the treatment’s potential future regulatory approval.
Credit: Ralf Liebhold / Shutterstock.com
Biotech Berlin Cures, a company focusing on neutralising functional autoantibodies (fAABs), is expanding its Phase II clinical trial on Long COVID (post-COVID syndrome). into a pan-European, multi-center collaboration.
The study will provide “meaningful and robust results on the efficacy and tolerability” of its lead drug candidate BC 007 in individuals with Long COVID.
A total of 12 sites in Germany, Austria, Switzerland, Finland, and Spain are working to advance clinical research into Long COVID. Additional trial sites in Switzerland, Spain and Germany are expected to soon follow, according to Berlin Cures.
Long COVID drug candidate BC 007
As a platform technology, BC 007 has the potential to cure different autoimmune diseases by targeting fAABs as their root cause, Berlin Cures stated. The compound has a similar function to an antibody, binding and neutralising harmful fAABs.
The biotech highlighted that in preclinical studies, the drug candidate demonstrated long-term autoantibody neutralisation after a single dose and significant improvement in cardiac function. Studies evaluated individuals who were healthy and fAAB-positive in a Phase I study and in heart failure patients in a Phase IIa trial.
Phase II clinical trial site locations:
Germany: 2x Berlin (recruiting), Cologne (recruiting), Münster (recruiting), Erlangen (active, recruitment begins soon)
Austria: 2x Vienna (recruiting)
Switzerland: Zurich (active, recruitment beginning 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)
First results of the Phase II clinical trial are expected in 2024.
In its investigation of the virus’ long-term impact on some individuals, if the BLOC Phase II trial garners positive results on efficiency, tolerability and the like, a larger Phase III study is expected to go ahead, supporting potential future approval of BC 007.
“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,” stated Oliver von Stein, CEO of Berlin Cures.
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