Starting in June 2023, Berlin Cures is conducting 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, safety, and tolerability of the substance with patients suffering from Long COVID. The results are expected in early 2024.
In the following sections, we provide regularly updated responses to the most frequently asked questions. If you cannot find answers to your queries on our website, please do not hesitate to reach out to us via this form.
Who is Berlin Cures?
Berlin Cures is a clinical-stage biotechnology company headquartered in Berlin, Germany, specialized 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.
What is BC 007?
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.
How does BC 007 work?
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 treating the root cause of autoimmune diseases.
Based on current knowledge, 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 shows that BC 007 doesn't significantly affect the IgG antibodies necessary for immune system function. However, it effectively neutralizes harmful fAABs and inhibits their synthesis for a certain period.
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, the tests are used to monitor patients, and the neutralization of fAABs can be confirmed with these tests.
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.
What are functional autoantibodies (fAABs)?
In contrast to simple destructive autoantibodies, so-called functional autoantibodies perform a hormone-like function in the body. They falsely turn on so called G protein-coupled receptors which can lead to an imbalance of hormonal control for different organs. Gerd Wallukat discovered this subclass of autoantibodies and described them for the first time in scientific research papers as early as 1987.
These AABs have the special characteristic of stimulating cells by undesirably turning on specific signal pathways which involve so-called G protein-coupled receptors. Via these specific cell surface receptors, functional autoantibodies trigger their hormone-like function.
Is BC 007 an available medicine?
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.
Is BC 007 currently available for purchase and accessible to me?
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.
What is a platform technology?
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 addressing diseases associated with fAABs through compounds neutralizing these fAABs can therefore be called a platform technology. Current research efforts are focusing on clinical trials with BC 007 in the indication Long COVID.
What is the present state of this research?
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 has received authorization by the relevant authorities in Austria, Germany, and Finland; Spain and Switzerland are also under evaluation. Several ethics committees have approved the study, including those for German testing centres. The process of negotiations and agreements with the clinics, a prerequisite for patient inclusion, is underway. First trial centres have started to admit patients in the study. We anticipate initial results by early next year.
What is the setup of the clinical Phase II study?
Our Phase II trial is the first clinical study of BC 007 for Long COVID. It is designed to provide the necessary groundwork to establish a larger approval study and other trials (e.g., involving patients with past SARS-CoV-2 infections) if positive results are obtained.
The study design involves 114 patients divided into three groups, with two dosage levels and a placebo arm, conducted in approximately a dozen centres 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).
When can we expect approval?
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.
Where will the phase II clinical trial take place?
The names of the testing centres will be announced once the approvals have been granted and the contracts with the centers have been signed. Actual trial site information will be updated in the registry on clinicaltrials.gov as new trial sites become operational.
Can people apply to take part in the trials?
Trial volunteers are selected by the investigators of the individual trial site. This is based on the inclusion and exclusion criteria listed in the trial protocol. Berlin Cures is not involved in this patient selection process. Please visit clinicaltrials.gov for further information.
What are the requirements / medical history / autoimmune values that a potential subject must have for a trial?
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.
As a participant, should I share my experiences in the trial with others?
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 behaviours 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 own 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 do 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.
What factors contributed to the period required to initiate the study?
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. Berlin Cures focused on preparing this documentation in Germany last year and submitted it to the regulatory bodies starting late 2022. With approval granted, the Phase II trial can now begin.
Is it possible that the positive outcomes from Long COVID therapeutic trials are due to a placebo effect?
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.
Why is Berlin Cures focusing on Long COVID?
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.
Is ME/CFS included in the current research studies?
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?”.
Does Berlin Cures collaborate with university hospitals that conduct their own research?
Berlin Cures is actively working with a number of 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.
Given the sharp increase in the number of cases, could BC 007 benefit from emergency approval like the vaccines against COVID did?
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.
Are there data available on heart failure research?
In dogs with 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.