Berlin Cures’ patented applications of BC 007 have shown positive results in the preclinical, clinical (phase I) as well as in the ongoing clinical phase IIa study in patients with advanced heart failure. Based on the observation that autoantibodies against G protein-coupled receptors play a relevant role in the development and maintenance of heart failure, four compassionate use treatments with BC 007 were performed at the University of Erlangen in patients with Long Covid Syndrome (LCS) who also had autoantibodies of the same class. The neutralization of the autoantibodies caused an immediate easing of LCS.
Depending on the source, it is assumed that about 10 to 30% of all patients infected with Corona virus suffer from Long Covid Syndrome (LCS) in varying degrees. Wallukat (Wallukat G et al., 2021) demonstrated that more than 90% of patients with LCS have autoantibodies against G protein-coupled receptors.
In four patients treated with BC 007 under compassionate use conditions at the University of Erlangen with the intention to neutralize these autoantibodies, an enormous remission of LCS could be achieved in a short time, so that one could speak of a cure.
This astounding result triggered an enormous international media response. In fact, BC 007 appears to be the only drug worldwide that may help cure LCS.
At the moment, Berlin Cures is – with utmost efforts – in the process of preparing a two-arm, double-blind, placebo-controlled clinical trial (RCT) to demonstrate the efficacy of BC 007 in a large number of patients with LCS.
The study design will be submitted to the relevant regulatory authorities for review in Q1 2022. Berlin Cures expects to receive the regulator’s feedback in 2022 on how to further proceed with our clinical studies. The main goal of Berlin Cures is to make BC 007 available on the market for LCS patients as fast as possible. The vast number of LCS patients worldwide clearly substantiates that the demand and the market potential for BC 007 for the treatment of LCS is enormous. For updated info please consult the News Section.
Berlin Cures’ aptamer BC 007 is the world’s only drug capable of neutralizing autoantibodies against G protein-coupled receptors. This class of autoantibodies is associated with a variety of different diseases. Heart failure triggered by dilated cardiomyopathy is one of these diseases in which these autoantibodies are detectable in about 50 percent of patients.
The detection of autoantibodies directed against the beta-1 adrenergic receptor is both cause and reason for the maintenance of this disease in patients with heart failure. Elimination of autoantibodies by immunoadsorption results in a survival benefit of more than 40 percent after 5 years compared to patients in whom these autoantibodies have not been removed.
BC 007 is the drug that will replace immunoadsorption and makes the treatment of autoantibody-induced heart failure available to all affected patients. Because of the complexity and high cost of treatment, immunoadsorption is only available for an extremely small fraction of patients.
Berlin Cures has demonstrated in a 2-arm randomized open-label Phase IIa clinical trial that in the majority of patients treated with BC 007, autoantibodies can be neutralized in the long term after a single dose. In addition, there was a significant improvement in cardiac function (measured as ejection fraction).
Furthermore, it could be shown that in patients who were not treated (control group), the autoantibodies did not disappear spontaneously, indicating the absolute necessity of treatment with BC 007 if autoantibodies should be detected in patients. The study is ongoing; however, recruitment for the study has been completed.
Up to Date information
For updated info please consult the News Section.