Berlin Cures to Evaluate BC 007, an Aptamer, in Patients for the Treatment of COVID-19
Phase II/III clinical trial is scheduled to start in the second half of 2020
Berlin, Germany – 24 June 2020 – Berlin Cures Holding AG, a biotech company developing aptamers for autoimmune diseases, today announces that it is evaluating BC 007, a β1-adrenoceptor autoantibody (β1-AAb) neutralizing ssDNA product, for the treatment of COVID-19. A Phase II/III clinical trial is scheduled to start in the second half of 2020. Results from an earlier Phase I study of BC 007 in a cardiac indication confirmed that it was safe and well tolerated.
Dr. Johannes Müller, Co-Founder, Chairman of the Board of Directors of Berlin Cures Holding AG, commented: “There is a clear and urgent need for effective treatment options of COVID-19 patients. We look forward to productive discussions with regulatory authorities, leading to the progression of BC 007 into a Phase II/III clinical trial later this year.”
BC 007, Berlin Cures’ lead clinical program, is currently in clinical development for patients with heart disease who carry autoantibodies against certain structures in the heart and which are responsible for heart disease.
BC 007 consists of a synthetically produced short and unmodified DNA sequence, known as an aptamer, which is able to bind to the spike protein of the coronavirus and inhibit viral replication, thus preventing the virus from both penetrating the cell and multiplying in the cell.
Basic investigations using nuclear magnetic resonance (NMR) spectroscopy have indicated that BC 007 can successfully attack SARS-CoV-2, responsible for the novel COVID-19. A specialized virology laboratory has confirmed that BC 007 could significantly inhibit the entry into the cell and replication of the virus inside the cell at dosages which have already been used in clinical tests.
Various approaches are currently under investigation for the treatment of COVID-19, including therapeutic antibodies. However, antibody development is time-consuming and cost-intensive, and many antibodies are possibly immunogenic.
BC 007 is a fully synthetic substance and can be produced quickly and in large quantities, is very stable in storage and has extremely few side effects. It does not trigger any immunological counteractions in the body.
Some of the targeted sequences possessed by COVID-19 are not unique and are seen in other viruses of this family. BC 007 could therefore not only inhibit COVID-19, but also further viruses.
As BC 007 is also highly water soluble, a therapeutic application such as a nasal spray or for inhalation is the next step of development in the fight against COVID-19.
In addition to inhibiting COVID-19, BC 007 has a beneficial effect on blood coagulation. BC 007 shows a moderate anticoagulatory effect preventing the formation of blood clots (microthrombi), one of the major causes of death in patients infected with the novel coronavirus.
Berlin Cures is fully committed to accelerating the BC 007 development as fast as possible, which consists of providing the regulatory authorities with the necessary documentation to enable them to make decisions regarding the approval of clinical trials.
For more information, please contact:
Berlin Cures Holding AG
Tel: + 41 78 811 06 77
About Berlin Cures
Berlin Cures Holding AG, is a spin-off from the Max Delbrück Center (MDC), the Charité Berlin and the German Heart Institute Berlin. It was founded by a group of scientists and Swiss investors and is based in Zug, Switzerland. A subsidiary, the Berlin Cures GmbH, is located in Berlin, Germany.
The scientists had been studying the significance of autoantibodies in heart disease and other autoimmune diseases for over 10 years. Gerd Wallukat from the MDC discovered these autoantibodies and described them for the first time in 1987. They have the special characteristic of stimulating cells via a highly specific signal pathway (so-called G-protein-coupled receptors) thereby sending pathological information and activating the cells in such a way that leads to long-term organ damage. These autoantibodies can be neutralized by the aptamer BC 007. The idea of binding autoantibodies with a highly specific aptamer is protected by a group of patents.
Find out more about us online: https://berlincures.ch/