STATEMENT: Berlin Cures makes progress in the fight against persistent COVID at the European level

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The German biotechnology company Berlin Cures is expanding its phase II clinical trial (BLOC) of its active ingredient BC 007 against persistent COVID, to 12 European research centers.

Right now, Spain is in the phase of recruiting patients to carry out the study in Valencia and Pamplona and, soon, Madrid, Malaga and Seville will follow.

Long COVID has become a serious global health problem and, therefore, Berlin Cures is working to provide an innovative therapeutic solution for millions of patients.

The Phase II clinical trial (BLOC) is designed to provide significant and robust results on the efficacy and tolerability of the lead drug candidate, BC 007, in patients with persistent COVID.

Spain, November 24, 2023.- Berlin Cures, a biotechnology company specialized in neutralizing functional autoantibodies, is expanding its phase II clinical trial (BLOC) and has created a pan-European and multicenter collaboration in the fight against persistent COVID. Thus, a total of 12 centers in Germany, Austria, Switzerland, Finland and Spain are working to advance clinical research on this growing global health problem. In addition, additional tests are expected to be carried out soon in Switzerland, Spain and Germany.

The first results of the phase II trial are expected in 2024 and, in case of positive results, Berlin Cures aims to conduct a larger phase III study, which is a prerequisite for the approval of BC 007.

"We are very excited to see that so many clinical institutions across Europe are working with Berlin Cures to transform the technology platform into a therapeutic solution for millions of patients," said Oliver von Stein, CEO of Berlin Cures. "As we intensify our efforts on a multinational scale, the goal is to provide a solution for long COVID, as well as redefine the approach for many other diseases associated with functional neutralizing autoantibodies, such as heart failure or glaucoma. This "Pan-European collaboration symbolizes a united front against an urgent health crisis and is a clear example of Berlin Cures' commitment to creating a true impact on society through innovation and science."

In this sense, the expansion of the study to five countries in Europe marks an important step in the multinational approach of Berlin Cures' Phase II BLOC trial. Thus, the study will provide significant and robust results on the efficacy and tolerability of the company's lead drug candidate - BC 007 - in patients with persistent COVID.

As a technological platform, BC 007 has the potential to cure different autoimmune diseases by targeting neutralizing functional autoantibodies as their root cause. Thus, the compound functions similarly to an antibody, binding to and neutralizing harmful functional neutralizing autoantibodies. In the case of persistent COVID, it is known that a considerable proportion is due to the presence of functional neutralizing autoantibodies and that is why Berlin Cures intends to be a pioneer in the development of a treatment based on BC 007 that addresses the core of the diseases. associated with these, such as persistent COVID, heart failure and glaucoma.

Summary of test site locations:

o Germany: 2x Berlin (patient recruitment phase), Cologne (patient recruitment phase), Münster (patient recruitment phase), Erlangen (active, starts recruiting soon)

o Austria: 2x Vienna (patient recruitment phase)

o Switzerland: Zurich (active, will start recruiting soon), Basel (open soon)

o Spain: Valencia (in the patient recruitment phase), Pamplona (in the patient recruitment phase), Madrid (active, starts recruiting soon); Malaga and Seville will follow soon.

o Finland: Helsinki (active, start recruiting soon)

All recruitment trial sites and participation criteria can be found on this page at Clinicaltrials.gov.

About Berlin Cures:

The Berlin Cures team has dedicated more than two decades to the research of functional autoantibodies and has successfully identified a molecule capable of effectively neutralizing them. Specifically, promising preclinical results have been observed for BC 007 as its efficacy was found in healthy volunteers with positive neutralizing functional autoantibodies during the Phase I study and in patients with heart failure in a Phase II trial, where it demonstrated neutralization of long-term autoantibodies after a single dose and a significant improvement in cardiac function, without spontaneous disappearance of autoantibodies in untreated patients. Its potential against long COVID is indicated by laboratory data generated with sera from long COVID patients and four case studies. By addressing the root cause of diseases associated with neutralizing functional autoantibodies with this unique biotechnology, Berlin Cures positions itself as one of the pioneering entities committed to addressing this critical problem at its root.

Since June 2023, Berlin Cures has been conducting a Phase II clinical trial with BC 007 in the Long COVID indication, an acute and increasing global health problem, to obtain significant and robust results on the efficacy and tolerability of BC 007 in patients suffering from Long COVID.

Contact Contact name: Fátima Terrasa Contact description: LLYC Contact phone: 932 17 22 17