Results of the Phase I study with BC 007.
Zug, Switzerland, and Berlin, Germany, 10 June 2020
A Three-Part, Randomized Study to Investigate the Safety, Tolerability, Pharmacokinetics and Mode of Action of BC 007, Neutraliser of Pathogenic Autoantibodies Against G Protein-Coupled Receptors in Healthy, Young and Elderly Subjects.
Niels-Peter Becker, Annekathrin Haberland, Katrin Wenzel, Peter Göttel, Gerd Wallukat, Hanna Davideit, Sarah Schulze-Rothe, Anne-Sophie Hönicke, Ingolf Schimke, Sabine Bartel, Matthias Grossmann, Angela Sinn, Laura Iavarone, Jan H. Boergermann, Kiley Prilliman, Georg Golor, Johannes Müller & Susanne Becker
BC 007 is a substance with a novel and innovative mode of action for the first-time causal treatment of chronic heart failure, associated with the occurrence of autoantibodies against the β1-adrenoceptor, and other diseases of mostly the heart and vascular system, being accompanied by the occurrence of functionally active agonistic autoantibodies against G protein-coupled receptors (fGPCR-AAb). The proposed mechanism of action of BC 007 is the neutralisation of these pathogenic autoantibodies which stimulate the respective receptor. To evaluate the safety, tolerability, pharmacokinetics and mode of action of BC 007, single intravenous infusions of increasing concentration were given to healthy young males and healthy elderly autoantibody-negative and autoantibody-positive participants of both sexes.