Drug developer Berlin Cures has launched a phase IIa trial for its β1-adrenoceptor autoantibody (β1-AAb) neutralizing ssDNA product BC 007. β1-AAbs have been identified as a relevant pathogenic cause of heart failure. BC 007 is now being tested as the first causative drug for patients with β1-AAb associated heart failure. Berlin Cures works with the cardiovascular CRO SCIRENT to test the new substance BC 007 in patients with chronic heart failure and reduced ejection fraction in a randomized, open-label phase IIa trial. The goal is to evaluate whether the treatment is safe and effective.
Heart failure is one of the most common causes of death in Western society and is becoming increasingly global. Its socio-economic impact is enormous, equivalent to the impact caused by cancer. Although there has been progress in treatment over the last decades, heart failure remains one of the main causes of cardiovascular mortality and hospitalization in adults.
With the discovery of agonistically acting autoantibodies which target G protein-coupled receptors (GPCR-AAb) such as the β1-adrenoceptor (β1-AAb) in heart failure a new therapeutic target has been identified. The removal of these autoantibodies via an extracorporeal method, the immunoadsorption, already shows its enormous benefit for the patients (M. Dandel, Eur J Heart Fail (14:1374)).
However, immunoadsorption has never been approved as a standard therapy for a variety of reasons related to patient burden and/or therapy costs. With the discovery of BC 007, a DNA-based therapeutic able to neutralize these autoantibodies in-vivo after infusion, a new option for widely applicable future causal treatment has opened. A successfully completed clinical phase I trial already included elderly, healthy, but GPCR-AAb positive tested subjects. Here BC 007 neutralized the GPCR-AAbs in a dose-dependent manner (for more detail, see J. Müller, The DNA-Based Drug BC 007 Neutralizes Agonistically Acting Autoantibodies Directed Against G Protein–Coupled Receptors– Successful Mode of Action Demonstrated in Clinical Phase 1 Trial).
Now, in phase IIa, twenty treated patients versus ten controls will be tested in a two-arm randomized, open-label study using the specialized cardiovascular trial sites managed by SCIRENT. Recruitment is going very well, with the sites hitting enrollment targets and deadlines.
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