Solid Phase II Trial Progress with Over 50% Patient Recruitment

Berlin Cures' BC 007 Targets Long COVID: Solid Phase II Trial Progress with Over 50% Patient Recruitment

• Berlin Cures, a clinical-stage biotechnology firm, advances innovative treatment aimed at combating Long COVID, currently impacting over 100 million people globally.
• Over 50% of patients in randomized placebo-controlled Phase-II-trial now recruited; no issues regarding safety observed.
• Berlin Cures innovative platform develops novel aptamer-based drugs to neutralize pathogenic functional autoantibodies, targeting diseases.

Berlin, Germany, 4 March 2024 – Berlin Cures, a clinical-stage biotechnology company, has reached a significant milestone in its Europe-wide clinical trial for Long COVID, effectively enrolling over 50% of the targeted 114 patients and expanding the study's inclusion criteria. The trial is investigating the efficacy of BC 007, the company's pioneering drug candidate designed to neutralize functional autoantibodies (fAABs), which play a key role in the persistence of Long COVID symptoms.

The study is actively progressing across 12 trial centers in Finland, Germany, Austria, Switzerland, and Spain, exemplifying the collaborative effort to address Long COVID, which has developed into a significant global health issue. Progress is strong and another seven centers are set to join soon. Anticipated results in autumn 2024 will pave the way for the next development stage, with Berlin Cures currently seeking additional funding to complete Phase II and initiate the crucial Phase III study necessary for regulatory approval.

"Long COVID is a global health crisis, negatively impacting over 100 million people worldwide, significantly reducing their quality of life and imposing substantial economic and social burdens. It puts immense pressure on our health systems and strains economic resources," states Oliver von Stein, CEO of Berlin Cures. “If we don't act now, we face spiraling healthcare costs, lost productivity, and widening social gaps. Our united front of clinical centers across Europe marks a pivotal move in confronting the pressing issue of Long COVID.”

As a biotech company focused on neutralizing fAABs, Berlin Cures stands at the forefront of developing innovative treatments for a variety of autoimmune diseases, including Long COVID, heart failure, glaucoma, and many others. Its drug candidate, BC 007, represents a promising solution by targeting harmful fAABs implicated in a range of autoimmune conditions such as Long COVID.

The ongoing Phase II clinical trial in Long COVID seeks to deliver conclusive and reliable results on the drug's effectiveness and safety for patients. The company anticipates a positive outcome, which will pave the way to proceed with a larger Phase III study, crucial for BC 007's approval.

BC 007 Could Potentially Cure Long COVID for Many
Current estimates indicate that functional autoantibodies (fAABs) are detectable in blood tests in about 40% of all Long COVID patients. Functional autoantibodies are a specific type of autoantibody that can develop as an immune response following infections, mistakenly target the body's tissues or cells. This interaction can lead to autoimmune diseases. Unlike normal antibodies that protect against infections, fAABs disrupt normal functions by binding to cell receptors or other proteins, often imitating or blocking natural signals needed for healthy cell functions. This disruption can result in a variety of autoimmune diseases, depending on the target of the autoantibodies and the role of the targeted tissue in the body.

“The presence of fAABs in such a large portion of patients highlights the potential of BC 007 to combat the underlying cause of Long COVID symptoms in a significant group of affected individuals. We are convinced of BC 007's therapeutic potential and are actively seeking support to prepare for a larger Phase III study," adds Oliver von Stein. "Our commitment to finding a cure for diseases caused by fAABs remains steadfast, supported by private funding since our inception."

Versatile Platform Technology Targeting Multiple Medical Conditions
The potential of BC 007 extends beyond treating a single disease, making it a so-called platform technology. By neutralizing fAABs, BC 007 could potentially act against many fAAB-associated diseases.

Built on more than two decades of fAAB-research, Berlin Cures has advanced BC 007 into clinical trials. This journey has demonstrated efficacy in Phase I studies with fAAB-positive volunteers and in a Phase IIa trial with heart failure patients, showing significant long-term benefits. Preclinical and clinical results with BC 007 have shown effective and lasting neutralization of fAABs after treatment. Moreover, BC 007 has proven to be safe and well-tolerated. With the ongoing Phase II trial focusing on Long COVID, Berlin Cures continues to seek additional investments and partnerships to advance this groundbreaking opportunity.

About Berlin Cures:
The Berlin Cures team has dedicated over two decades to the research of functional autoantibodies (fAABs) and has successfully identified a molecule capable of effectively neutralizing these. Promising preclinical results have been observed for BC 007. It was found effective in fAAB-positive healthy volunteers during the Phase I study and in heart failure patients in a Phase IIa trial, where it demonstrated long-term autoantibody neutralization after a single dose and significant improvement in cardiac function, with no spontaneous disappearance of autoantibodies in untreated patients. Its potential against Long COVID is indicated by lab data generated using sera from Long COVID patients, and four case studies. By tackling the root cause of fAAB-associated diseases with this unique biotechnology, Berlin Cures emerges as one of the pioneering entities committed to addressing this critical issue at its core.

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

Contact:
FGS Global
E-Mail:  berlincures-eu@fgsglobal.com
Tel:  +41 79 678 46 03