Berlin Cures Set to Launch Phase 2 Study of Heart Failure Drug
BC007 Neutralizes Autoantibodies That Cause 80% of Dilated Cardiomyopathy
ZUG, Switzerland, and BERLIN, Germany, January 7, 2018 – A drug designed to neutralize autoantibodies linked to heart failure is set to begin Phase 2 testing early in 2018, the drug’s developer, Berlin Cures, said today.
The double-blind study will evaluate the effectiveness of a DNA aptamer-based compound, known as BC007, which binds to and neutralizes pathogenic autoantibodies directed against the beta-1 adrenoceptor regulating the heart’s rate and contraction strength. When autoantibodies bind to this receptor heart cells are harmed and may eventually die in a process that has been found to lead to organ failure in 80 percent of dilated cardiomyopathy patients.
Berlin Cures plans to enroll 350 subjects in Germany, Serbia, Switzerland, Austria and the Netherlands.
“With BC007, we are demonstrating the effectiveness of the first treatment for an autoimmune cause of heart disease,” Berlin Cures founder, chairman and president Dr. Johannes Müller said.
Berlin Cures is concluding a Phase I study early this year and will present the findings in March 2018 at the American College of Cardiology’s annual scientific meeting in Orlando, Florida.
Phase 1 confirmed that ascending doses of BC007 were safe and effective in neutralizing autoantibodies directed against the beta-1 adrenoceptor as well as additional autoantibodies belonging to same family of cell-surface receptors known as G-protein coupled receptors.
In fact, because BC007 has shown a high affinity and specificity for all G-protein coupled receptor autoantibodies, the company is developing additional aptamer drugs based on BC007’s mechanism of action to neutralize other GPCR autoantibodies linked to pulmonary hypertension, glaucoma, pre-eclampsia and other diseases.
A single short intravenous infusion of BC007 is an efficient alternative to immunoadsorption, a blood-washing procedure to remove autoantibodies that is invasive and generally requires hospitalization for up to one week.
In an earlier study of 163 subjects taking advanced heart failure medications as they awaited heart transplantation, immunoadsorption eliminated autoantibodies, leading to improved heart function and a 40+ percent increase in the probability of survival at five years compared to projected survival in subjects not receiving immunoadsorption. These findings were first reported in the European Journal of Heart Failure.
“We aim to show how a short infusion of BC007 resulting in sustained elimination of autoantibodies against the beta-1 adrenoceptor can replace the costly and burdensome process of immunoadsorption or the need for a cardiac assist device,” Dr. Müller remarked.
About Berlin Cures
Berlin Cures Holding AG, a privately-held company founded late in 2014 and based in Zug, Switzerland, is building a new generation of treatments based on a quarter of a century of research on autoimmune diseases conducted at the renowned Charité Berlin and at the Max-Delbrueck-Center in Berlin. The focus is developing treatments for diseases with autoimmune pathology in which functional autoantibodies directed against G-protein coupled receptors of different types are present. Research and development is conducted at Berlin Cures GmbH, a subsidiary in Berlin.
The family of G-protein coupled receptors, with over 1000 different sub-types, constitutes the largest protein super-family with the physiological ability to sense molecules outside the cell. Berlin Cures holds the IP for a platform of aptamers that bind to and neutralize these functional autoantibodies, which play an important role in the pathophysiology of several autoimmune-diseases.
Recent studies involving heart failure, pulmonary hypertension, chronic fatigue syndrome, pre-eclampsia and a significant number other diseases have shown that these functional autoantibodies play a highly underestimated role in disease development and sustenance. Neutralizing these autoantibodies can lead to substantial improvements in treatment.
For more information, visit www.berlincures.ch.
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Berlin Cures Holding AG
Russo Partners, LLC
Tony Russo, Ph.D.