New article from german Tagesspiegel on BC007 trial.
https://www.tagesspiegel.de/gesundh...ch-studienteilnehmer-fur-bc-007-11156413.html
Translated with ChatGPT:
Long-awaited substance against Long Covid: Participants sought for BC 007 study
Many patients are anxiously awaiting a substance. The CEO of Berlin Cures, the development company behind BC 007, explains why the criteria for participant recruitment have now been changed.
The hope among the affected individuals is immense: The substance BC 007, currently undergoing testing and developed by the Berlin-based company Berlin Cures, is intended to cure Long Covid or at least significantly alleviate its symptoms. The symptoms, including fatigue, the dreaded exhaustion syndrome, are believed to be related to specific autoantibodies. BC 007 is a so-called aptamer designed to block the disease-causing autoantibodies.
Whether this really works is currently being investigated by Berlin Cures in a Phase 2 study. We spoke with Oliver von Stein, the CEO of Berlin Cures, about whether participants are still being sought for the study, where research is being conducted, and when the first results will be available.
What is the current status of the study?
Can you say anything about how it's progressing?
The study is proceeding according to plan and is currently being conducted in twelve study centers across five European countries. Seven additional study centers will begin recruiting participants in the near future.
The original plan was to stick to those twelve mentioned centers. Why are there significantly more now?
We want to ensure that the number of study participants is large enough to be able to conclude recruitment as planned in May 2024. Therefore, we are adding more centers that can provide a larger pool of potential participants. This allows us to include participants in the study more quickly.
Will the number of participants also increase?
No. The plan is still to have the originally designed 114 participants with Long Covid according to the study design. But we want to increase the pace. So far, we have only reached a little over a third of the recruitment target. That's why we have not only added more study centers but also expanded the inclusion criteria for participants.
This will surely be of interest to many potential participants: How have you changed the criteria?
Originally, we planned to include only participants who had a maximum of one year since the Covid infection. With the approval of the German drug regulatory authority BfArM, we can now expand this to include individuals with Long Covid where the infection occurred longer ago. Also newly included are affected individuals with a stable chronic illness unrelated to the newly occurring Long Covid symptoms, such as diseases like diabetes or glaucoma. However, severe coexisting conditions like cancer are still excluded.
If having the highest number of participating patients is crucial for data quality, wouldn't it make sense to acquire more than the mentioned 114?
Many severely affected individuals with Long Covid have high hopes for BC 007 and would surely like to participate in the study.
Unfortunately, that's not possible. The production of the necessary doses of BC 007 is so complex and expensive that we can only provide a limited quantity for the studies. And since production takes a long time, we can't easily increase the quantity.
What makes BC 007 so expensive and complex?
There are various reasons for that. Firstly, the test substance is subject to numerous regulations to ensure quality. Secondly, BC 007 is made from DNA. It is not a small molecule synthesized or a biologic produced in a bioreactor or by microorganisms, like other substances. There are only a handful of contract manufacturers capable of producing such a medicine in the high quality we need. Lastly, it is produced in very small quantities for clinical studies. All of this results in BC 007 being currently expensive to manufacture. Only after approval and large-scale production can economies of scale make production more cost-effective.
That's why there was a long dispute with the University Hospital Erlangen. Berlin Cures had promised doses of BC 007 to the hospital for its own small study on the effectiveness against Long Covid. However, your company cited delivery difficulties. Has the dispute been resolved by now?
Yes, Erlangen received the promised doses of the substance for their study last fall. And we have even deepened the cooperation because we managed to integrate the University Hospital as the fifth German study center into our Long Covid study.
Which study centers are there in Germany besides Erlangen?
In addition to Erlangen, Charité – Universitätsmedizin Berlin is participating, along with Gemeinschaftskrankenhaus Havelhöhe in Berlin-Spandau and the university hospitals in Cologne and Münster.
Can individuals who want to participate in the study register themselves?
Yes, that is possible. Admission to the study is based on the inclusion and exclusion criteria listed in the study protocol. Since Berlin Cures is not involved in the recruitment of participants, affected individuals should contact a nearby study center directly. All study centers still looking for participants, along with the respective lead physicians, can be researched on the website clinicaltrials.gov.
If you can complete the recruitment for the study by May as planned, when do you expect the results on whether BC 007 is effective against Long Covid?
If we maintain the acquisition pace and can reach the required number of participants, I expect that we will have initial results in the fall of 2024.
How does the study proceed exactly – and what is the endpoint at which you would say the study was successful?
Each participant receives two doses of the medication at 30-day intervals – and the control group receives a placebo. As in any study, we have defined criteria for endpoints where we would consider it successful. One of the most important is a significant improvement in the fatigue associated with Long Covid, compared to the control group.
Even with success in this Phase 2 study, the path to a medication available to patients is still far. For that, there would need to be an approval, or Phase 3, study. This would be much more extensive than the current one and accordingly more expensive.
For this approval study, we are looking for additional capital investors or partners. The costs for this go into the higher double-digit million range. This is no longer entirely feasible for a small company like Berlin Cures solely with the funds of current private investors. Some additional investors have already been found, but more are still needed.
The search is challenging as long as there is no approved medication or at least a successful Phase 2 study. However, since I am very confident that we will soon have a success to show, I hope the search for investors will be significantly easier afterward.
Have you inquired with the German government whether you can get money from the funding pool for Long Covid research that was decided upon last year?
This pool – whether it is 100 million or 20 million euros, as rumored now – is initially a positive signal that the German government is engaged in the field. However, it is not a game-changer that quickly provides new therapies against Long Covid. The sums are relevant for smaller research projects, but they are not decisive for the development of new drugs in large pharmaceutical companies. We have, of course, also inquired whether our research qualifies for public funding. However, so far, with little success.
Recent research results published by the University of Zurich suggest that the immune system plays a significant role in Long Covid. According to the findings, the defense system remains active even after a Covid infection, attacking blood cells and tissues, leading to symptoms such as fatigue and shortness of breath. There is no mention of harmful antibodies in this context. Do these results make you nervous?
No, on the contrary. We view these results as confirmation of Berlin Cures' scientific approach, emphasizing the importance of an overactive immune response in Long Covid. The BC 007 substance is designed to neutralize harmful functional autoantibodies that arise in response to the misguided immune reaction.
The fundamental synergy between the Zurich study and the long-standing research findings of Berlin Cures could be a significant step towards a more comprehensive understanding and improved treatment of Long Covid.
