- - Phase 2 initiation anticipated in Q42018
ZUG, Switzerland, Aug. 22, 2018 /PRNewswire/ -- Drug developer Berlin Cures today announced the successful completion of its Phase 1 study of BC 007, a DNA-based aptamer compound that binds to and eliminates functional pathogenic autoantibodies for the treatment of cardiomyopathy.
"The safety profile of BC 007 continues to be excellent," said Dr. Johannes Müller, founder and president of the Board of Directors of Berlin Cures Holding AG. "The completion of the study has happened well within the projected time frame and will provide us with valuable information for the design of our upcoming Phase 2 study with respect to dose and treatment frequency. With this encouraging development we hope to address the tremendous need for novel, safe and effective treatment options for the millions of people living with cardiomyopathy."
"The therapeutic benefits of BC 007 could constitute a paradigm shift in the treatment of heart failure towards personized medicine for heart diseases," said Marko Bagaric, CEO and member of the Board of Directors of the company. "The safety and tolerability profile of BC 007 combined with the proof that all tested autoantibodies can be eliminated by a moderate dose of the compound provide an optimistic outlook for our investors in the upcoming clinical study. Additionally, this optimism is supported by the established knowledge that removal of the autoantibodies by a procedure known as immunoadsorption leads to a significant benefit for patients suffering from dilated cardiomyopathy. "
About autoantibodies against G-protein coupled receptorsVarious causes are known for the development of dilated cardiomyopathy, where the heart's main pumping chamber is enlarged and weakened. One of these causes are functional pathogenic autoantibodies, which bind to the beta-1 adrenoceptor and interfere with the regulation of the heart's rate and contraction strength, leading to a continuous overstimulation of the heart muscle and heart failure in the long run. Berlin Cures has developed BC 007, a compound capable of eliminating the pathogenic autoantibodies targeting the beta-1 adrenoceptor. Additionally, BC 007 can also neutralize other autoantibodies belonging to the same large family of cell-surface receptors, known as G-protein-coupled receptors (GPCR), which can induce dilated cardiomyopathy and various diseases such as pulmonary hypertension, chronic fatigue syndrome and glaucoma. To facilitate the identification of such autoantibodies, Berlin Cures has standardized a test procedure which allows to reliably detect autoantibodies in the sera of patients, replacing an available yet complex and unvalidated diagnostic test procedure.
About Phase 1 of the compound BC 007The objective of the Phase 1 study was to demonstrate safety, tolerability and efficacy of BC 007 in the elimination of autoantibodies. While young healthy men who had no autoantibodies were initially dosed with low doses of BC 007 placebo-controlled, in the further development of the study older subjects (females and males) who were tested positive for autoantibodies were treated with increasing doses of BC 007. The optimal dose for complete elimination of autoantibodies was determined without any serious adverse events or any signs of allergic reactions of the 74 treated individuals. This optimal dose shall be taken to progress into a Phase 2/3 trial with beta1-adrenergic receptor-AAB positive patients suffering from chronic heart failure.
About BC 007BC 007 is a DNA-based aptamer compound that binds to and eliminates functional pathogenic autoantibodies directed against the beta-1 adrenoceptor, a receptor belonging to the large family of cell surface receptors known as G-protein coupled receptors that regulate the heart's rate and contraction strength. Heart cells are harmed by autoantibodies that chronically bind to these receptors in a process that has been found to lead to heart cell death and organ failure in about 80 percent of middle European patients with dilated cardiomyopathy waiting for heart transplantation.
About Berlin CuresBerlin Cures Holding AG, a privately-held company founded in 2014 and based in Zug, Switzerland, is establishing a new generation of treatments based on research of autoimmune diseases conducted at the renowned Charité Berlin and at the Max-Delbrueck-Center in Berlin for over a quarter of a century. The focus is to develop treatments for diseases with autoimmune pathology in which functional autoantibodies directed against G-protein-coupled receptors of different types play a significant role.
With over 1000 different sub-types, the family of G-protein-receptors 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 of 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, https://www.berlincures.ch.
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