Berlin Cures develops DNA-based aptamers designed to specifically target and neutralize functional autoantibodies (fAABs) directed against G-protein coupled receptors (GPCRs). There is a growing body of scientific evidence that demonstrates fAABs play a key role in the pathogenesis of various debilitation diseases. Neutralizing fAABs offers a unique therapeutic modality for the treatment of diseases such as heart failure, Long COVID, glaucoma, and others.
We continue to expand our pipeline with aptamer-based compounds to treat diseases caused by the presence of fAABs.
The pathogenesis of heart failure is complex and not completely understood. However, the presence of functional autoantibodies can be detected in approximately 50% of subjects with heart failure. Previous studies have shown that the elimination of functional autoantibodies by immunoadsorption resulted in a survival benefit of more than 40 per cent after 5 years compared to patients in whom these autoantibodies have not been removed.
While immunoadsorption is highly effective and well known to selectively remove immunoglobulins it is not suited for routine use due to its complex administration, costs and length of procedure. Through extensive research, Berlin Cures has developed a DNA-based aptamer BC 007 that specifically binds to and neutralizes functional autoantibodies against G protein-coupled receptors.
In a controlled open-label Phase IIa study in subjects with heart failure, BC 007 achieved long-term neutralisation of functional autoantibodies after a single dose. By contrast, all subjects in the non-treated control group remained positive for functional autoantibodies throughout the duration of the study.
Based on these encouraging data and the high unmet medical need, Berlin Cures will advance the clinical development of BC 007 through a controlled Phase IIb study in heart failure subjects.
By leveraging the company’s technology platform, additional aptamer compounds are being developed for further indications in cardiology and other disease where functional autoantibodies play a causative role.
Depending on the source, it is estimated that about 10 to 30% of all patients infected with coronavirus suffer from Long COVID Syndrome (LCS) in varying degrees. Wallukat G et al., 2021 demonstrated that a high percentage of patients with LCS have autoantibodies against G protein-coupled receptors.
Under a compassionate use program conducted at the University of Erlangen, four subjects with Long COVID were treated with BC 007 with dramatic results. In all subjects, a rapid remission of symptoms was observed following treatment.
Berlin Cures is currently conducting a Phase II study in five European countries, in subjects with Long COVID and results are anticipated in 2024. The company is optimistic that a positive outcome of the Phase II Long COVID study will pave the way forward to treat other disabling and complex illnesses such as Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).
