Berlin Cures Holding AG announces start of phase-1 study of BC007
ZURICH (Switzerland), November 14, 2016 — Berlin Cures Holding AG announces the start of the clinical Phase-1-first-in-human-study of its drug candidate BC007. The study is a 2-part design with part 1 being a randomized, double-blinded, ascending single-dose study in healthy subjects, followed by part 2, which is an open, ascending single-dose study in autoantibody-positive but otherwise healthy elderly subjects (proof-of-concept). For more details on the study design please refer to clinicaltrials.gov (NCT02955420). The study will be completed in December 2016. The full results of the study are expected to be published in March 2017.
BC007 is an aptamer that binds and neutralizes functional autoantibodies directed against G-protein-coupled receptors. The first targeted indication of BC007 will be cardiomyopathy with chronic congestive heart failure in patients that are positive for autoantibodies directed against the beta-1-receptor of the heart.
About Berlin Cures
Berlin Cures Holding AG is a privately held Swiss pharma-start-up-company founded in 2014. The company aggregates 25 years of common research activities in autoimmune diseases of the renowned Charité Berlin and the Max-Delbrueck-Center. Berlin Cures focuses on the therapy of diseases with autoimmune pathology in which functional autoantibodies directed against G-Protein coupled receptors of different types are present. The company holds the IP for a platform of aptamers that bind and neutralize those autoantibodies. 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. Pathological functional autoantibodies can bind to these receptors, thus inducing or sustaining widely spread diseases including heart failure.
„These antibodies play an important role in the pathophysiology of several autoimmune-diseases. As we have learned in recent years, even in patients with heart failure, pulmonary hypertension, chronic fatigue syndrome and a number other diseases, functional autoantibodies play a significantly underestimated role in development and sustaining of these diseases. Therefore, neutralizing those autoantibodies with our substance BC 007 will lead to a substantial improvement in the treatment of patients with autoantibody-induced diseases“, says Dr. Johannes Müller, president of Berlin Cures Holding AG and CEO of Berlin Cures GmbH, the Swiss company`s research & development subsidiary in Berlin. For more information refer to www.berlincures.de.