Frequently Asked Questions

Berlin Cures is a clinical-stage biotechnology company headquartered in Berlin, Germany, specialising in autoimmune diseases that are caused by functional autoantibodies (fAABs). The Berlin Cures team has dedicated over two decades to the research fAABs and has successfully identified a biotechnology capable of effectively neutralizing these. Berlin Cures was established in 2014 with the intent to transition from concept to therapeutic solutions.

BC 007 is an aptamer, composed of a sequence of 15 DNA building blocks (nucleotides) that form a unique three-dimensional structure (G-quadruplex). It functions similarly as an antibody, binding and neutralizing harmful functional autoantibodies (fAABs) in the body, thereby treating the root cause of autoimmune diseases.

BC 007 is an aptamer, composed of a sequence of 15 DNA building blocks (nucleotides) that form a unique three-dimensional structure. It functions similarly as an antibody, binding and neutralizing harmful functional autoantibodies (fAABs) in the blood, thereby addressing the root cause of diseases caused by the presence of fAABs.

Based on clinical experience, BC 007 is minimally or non-immunogenic and is very well tolerated. It only induces temporary blood thinning during infusion, which may contribute to its efficacy, as tiny blood clots are suspected to be one of the causes of Long COVID symptoms. This blood thinning effect disappears within minutes after the infusion ends.

Importantly, laboratory data have demonstrated that BC 007 doesn't significantly affect the IgG antibodies necessary for immune system function. Rather BC 007 effectively neutralizes harmful fAABs and prevents their synthesis for s prolonged periods.

Berlin Cures has developed a testing system to detect the presence of fAABs. These tests are used to identify Long COVID patients suitable for inclusion in the study. During the study period, the tests are used to monitor both the neutralization of fAABs following treatment and the duration of response.

With BC 007 we have a biotechnology that can potentially cure several diseases. Our company is pioneering the use of this platform technology to neutralize fAABs in several diseases. Further information on this topic can be found in the subsequent section.

In contrast to simple destructive autoantibodies, so-called functional autoantibodies perform an activation function in the body. They can falsely over stimulate so-called G protein-coupled receptors which in turn may activate certain signaling pathways resulting in the development of fAAB related diseases. Gerd Wallukat discovered this subclass of autoantibodies and described them for the first time in scientific research papers as early as 1987.

BC 007 is a substance currently undergoing clinical trials. Only after successful completion of the required clinical trials and approvals by the relevant regulatory authorities will BC 007 be available as a medicine.

BC 007 is presently not in distribution, and Berlin Cures does not dispense doses. The limited quantity of the drug is reserved for clinical trials. Our primary focus is to progress with the research.

Functional autoantibodies (fAABs) can be the root cause of several autoimmune diseases, including subsets of coronary heart diseases, certain eye diseases, as well as Long COVID syndrome. Hence, compounds that can neutralize fAABs could potentially be effective against multiple diseases. The Berlin Cures approach of targeting diseases associated with fAABs using drug compounds that neutralizing fAABs can be called a platform technology. Current research efforts are focusing on clinical trials with BC 007 in the indication Long COVID.

The successful completion of the Phase II clinical trial in Long COVID is the next milestone in the process of obtaining approval for BC 007. This trial is currently being conducted in five European countries. With this multinational approach, Berlin Cures intensifies its efforts to develop a cure for Long COVID as well as for other fAAB-associated diseases such as heart failure or glaucoma. We anticipate initial results for the Long COVID Phase II study in 2024.

Our Phase II trial is the first clinical study of BC 007 for Long COVID. It is designed to provide the necessary groundwork to support a larger approval study and other trials (e.g., involving patients with past SARS-CoV-2 infections) if positive results are obtained.

The study involves 114 patients divided into three groups, with two dosage levels and a placebo arm, conducted in approximately a dozen centers across five countries.

The objectives are to neutralize fAABs, evaluate efficacy (marked improvement of severe symptoms), and assess safety and tolerability (so far, BC 007 has been very well tolerated in about 100 subjects and patients).

If the Phase II trial yields positive results, Berlin Cures will apply for approval to begin the required Phase III. The decision regarding this will be made after the analysis of the Phase II trial results. If the Phase III program will be successful, Berlin Cures will submit BC 007 for approval to the regulatory authorities.

All participating trial centers are listed on clinicaltrials.gov. This list will be regularly updated as further trial sites become operational.

Trial volunteers are selected by the investigators at the trial sites. based on specific inclusion and exclusion criteria that are listed in the trial protocol. Berlin Cures is not involved in this patient selection process.

Inclusion criteria: SARS CoV-2 infection occurred between 3 to 12 months ago, regardless of vaccination status; age 18 years and older with no upper limit, experiencing moderate to severe fatigue. Please visit clinicaltrials.gov for further information.

We urge all participants to not share details about their trial participation publicly, specifically on social networks online, as it could jeopardize the validity of the results.

As part of the trial procedure, participants have agreed to protect and promote the accuracy and reliability of the data collected. Individual experiences shared online may be misinterpreted or lead to behaviors that could ultimately bias the results of the trial. For example, a social media post could influence how other (potential) participants perceive or report their symptoms, making it more difficult to evaluate whether the treatment is working.

Ensuring valid results is critical to a rapid approval process. The Phase II trial is designed to provide meaningful and robust results on the efficacy, safety and tolerability of BC 007 in patients suffering from Long COVID. If the Phase II trial shows positive results, Berlin Cures will apply for approval to start the required Phase III trial, which is a prerequisite for regulatory approval of a treatment.

Please inform your doctors or other healthcare providers about your trial participation. There is also no issue in sharing your experiences confidentially with family members, friends or other people close to you. They are also requested to keep the information confidential.

Before a clinical trial can start, all the relevant regulatory authorities perform a thorough examination of documentation of the test substance, laboratory tests, and the clinical trial protocol. Once this review process is complete, approval for the trial can be given. In 2022, Berlin Cures focused on preparing this documentation in Germany and submitted it to the regulatory bodies starting late 2022. Following their approval, the Phase II trial has been initiated in June 2023.

This is highly unlikely. The participants in these trials might have previously undergone multiple treatments. If a placebo effect were to be responsible, it would have been expected to manifest during one of those prior treatment stages.

Approximately 100 million people globally are affected by Long COVID; about 36 million patients have been afflicted in Europe, and more than 1 million individuals in Germany live with Long COVID. Many patients experience severe symptoms and face the risk of developing chronic fatigue syndrome (CFS) and prolonged incapacity to work – in the UK, an estimated 0.5 million Long COVID patients are unable to work. An early treatment of Long COVID could prevent chronification leading to ME/CFS.

Effective therapies are essential to prevent long-term health damage, reduce downtime, and enable those affected to lead a fulfilling life. In the absence of effective therapies, Long COVID poses significant and escalating costs to our societies. The symptoms triggered by the coronavirus infection are diverse and potentially overlapping. In a large proportion of patients, functional autoantibodies (fAABs) can be detected, which can be neutralized with BC 007. The activity of these fAABs could explain many Long COVID symptoms.

Thus, it is crucial and necessary to treat patients from this large group of fAAB-positive individuals with BC 007 in a robust clinical trial.

At this stage we direct our efforts and the development of BC 007 towards Long COVID. Our objective is to contribute to a cure. An early treatment of Long COVID could prevent chronification leading to ME/CFS.

Our work so far has been funded exclusively through private investors. As we transcend our heritage as a small, specialized research company we are opening up to strategic and institutional investors. Once we have additional resources in place, we can advance testing of our platform technology on further indications. For more details about the platform technology, kindly refer to “What is a platform technology?”

Berlin Cures is actively working with several university hospitals which will participate in the Phase II Long COVID trial. Our clinical trial program is essential to getting a safe and effective medicine to market that has the potential to help millions of patients, this is therefore our top priority. We welcome and respect the research carried out by academic institutions and we are open to collaborations once the immediate needs of our clinical trial program have been met.

The research findings on Long COVID recently published by the University of Zurich suggest that immunological processes may play an important role in the development and persistence of the disease. These findings are in line with Berlin Cures' scientific approach, which emphasises the role of an overactive immune response in Long COVID. The focus of Berlin Cures and the active ingredient BC007 is on harmful functional autoantibodies that arise in response to the misdirected immune reaction, and which are to be neutralised by the active ingredient. The fundamental synergy between the Zurich study and the long-standing research results of Berlin Cures may be a significant step towards a more comprehensive understanding and improved treatment of Long Covid.

We will continue to develop BC 007 with focus and priority. We cannot speculate about the accessibility of an emergency approval path open to BC 007 in the future.

In a well-recognized animal model of heart failure, a pronounced positive effect on survival was observed following the administration of BC 007. In humans, targeted removal of antibodies through a type of blood wash significantly extended the survival of patients with heart failure.

A Phase IIa study with BC 007 in patients with a common form of heart failure (dilated cardiomyopathy) demonstrated that harmful fAABs can be neutralized in many patients after a single infusion of BC 007; after one or two infusions, neutralization is achieved in the majority of patients. Currently the clinical data from this phase IIa trial is being evaluated.