Long Covid drug BC-007 research news

RedFox

RedFox

Senior Member (Voting Rights)
Change.org petition to fund and expedite BC-007 research

BC007 NOW- Chance of a cure for millions of suffering people
From the English description
call on the German government to financially support the approval studies of the company Berlin Cures GmbH for the drug BC 007 and to remove bureaucratic hurdles to enable an accelerated approval process.

We call on the German government to expand biomedical research on long-covid, ME/CFS and post-vaccine syndrome and to increase government funding for further clinical trials and appropriate therapies to at least 100 million euros for an initial period of 24 months.

We call on the German government to expand the long-covid outpatient clinics into interdisciplinary treatment centers, to improve the network between medical disciplines and to promote further training for physicians in the aforementioned pathologies.

We call on the Germanl government to simplify the bureaucratic processes for social security for those affected.

My take
This is not an official petition through any government, but people in Germany will be able to use this as evidence of public support. I signed it and hope you do too. BC-007 isn't the sure shot some people insist it is, but every drug candidate for LC and ME/CFS should be researched quickly and thoroughly.
 
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This looks like a serious muddle.

Why should normal process be bypassed for a treatment that so far has little credibility and no evidence of effectiveness?

What has it got to do with 'post-vaccine syndromes"?

What is the point of 'interdisciplinary treatment centres' if we have no treatments?
 
The early tests on a couple of Long Haulers and on one ME/CFS patient showed full recoveries from the drug almost immediately. This has a lot of people excited that its a miracle drug. In practice the drug seems to constantly running into roadblocks for the stage 2 and 3 trials and has funding issues and a few trials that were tried independently couldn't get the drug at all, its not really available to researchers or anyone at this stage. It might be a miracle cure, it might be more smoke and mirrors or anything in between but its not got far in its testing and every year the trials get delayed a year. My funny business alert keeps going off for this one.
 
Jonathan Edwards said:
This looks like a serious muddle.

Why should normal process be bypassed for a treatment that so far has little credibility and no evidence of effectiveness?

What has it got to do with 'post-vaccine syndromes"?

What is the point of 'interdisciplinary treatment centres' if we have no treatments?
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My own opinion is this: Berlin Cures is waiting for government approval to start a trial. This should be given without unnecessary delay. If trials show BC-007 works, it must be approved promptly. They also want funding for trials. That would be great, but it seems like money is already available.
 
Many ME/CFS scams of this nature have come and gone over the years. It always boils down to the scammer claiming he/she has a high accuracy diagnostic test or a potent treatment/cure, always presented in a fuzzy-on-the-details manner while presenting himself as a rebellious lone wolf scientist working against the evil slow uncaring medical authorities/govt, creating a false sense of urgency (publication in a peer reviewed journal? normal regulatory process? pffft, those things are for suckers) to scam people out of their money/hope.
 
Is there any reason to think that the German government is delaying, though? @RedFox

My understanding was that Berlin Cures had withdrawn their proposal for an ME trial.
All trials need to go through ethical approval. For novel treatments that, and adequate safety data, is about all that regulators require. Do they have adequate safety data, I wonder?
 
Jonathan Edwards said:
Is there any reason to think that the German government is delaying, though?
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You're making me think critically here, and take a more balanced approach. The latest news we heard a few months ago was that they were doing quality control. I think many people grumbled "They're delaying it again!" when that news was released, and this attitude seeped into my mind as well. Looking at this more carefully, there's no evidence the government is dragging their feet, and Berlin Cures has every incentive not to. Still, science tends to work faster when there's a sense of urgency--we saw this repeatedly during the pandemic--so keeping BC-007 in the spotlight isn't a bad thing. And I've also heard of some communication issues between Berlin Cures and Erlangen--I hope those have been resolved.
 
Merged thread

"Long-Covid drug from Berlin is being tested" (Update on BC-007)

Long-Covid-Arznei aus Berlin geht in die Prüfung
https://www.faz.net/aktuell/wirtsch...vid-mittel-bc007-ist-finanziert-18390943.html

Long-Covid drug from Berlin is being tested
Translated with Google Translate

Hopefuls in the fight against Long Covid can go into closer medical examination after funding commitments: The start-up Berlin Cures has collected the money for a phase two patient study on the active ingredient BC007, as board members and co-owners Ulf Berg and Rainer Böhm told the FAZ said.
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Key takeaways:
They're getting serious now. No flaunting heady testimonals on social media, no touting tiny unblinded studies. They're finally putting this drug to the test with a phase 2 trial involving over 100 participants. Other points:
  • They raised several million in funding for this, but they have yet to receive regulatory approval
  • Results are expected between August and December 2023
  • If successful, it could lead to a phase 3 trial and approval in 2024
One thing we don't have word on is the progress of a trial in ME/CFS.
 
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BerlinCures has now received the necessary approvals for their phase II clinical trial with BC-007 for Long COVID in Germany. In this thread is a short summary of the other new information in this article.
https://www.tagblatt.ch/leben/long-...te-medikamentenstudie-ld.2430543?reduced=true
The study is planned to start in the second quarter of 2023.
Besides Germany the study will also take place in Switzerland, Austria, Finland and Spain.
In these countries Berlin Cures is still waiting for the necessary approvals.
Altogether the number of participants will be over 100. One third will be getting a placebo, 76 the drug, in two different dosages.
Unfortunately only people whose initial infection has not been longer ago than 12 months are allowed to take part in the trial.
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https://www.clinicaltrialsregister.eu/ctr-search/trial/2022-003452-14/DE

As noted by @Wyva, inclusion criteria include —

6. The participant has a previous positive SARS-CoV-2 test result (PCR test or documented rapid antigen test) not older than 12 months at screening and reported long COVID symptoms starting no later than 12 weeks after the first positive test and might have had a symptom-free interval between the acute phase of infection and the occurrence of long COVID symptoms as defined by the WHO.
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Exclusion criteria include —

1. Any history or evidence of any clinically significant cardiovascular (specifically tachycardia including Postural Orthostatic Tachycardia Syndrome.
[...]
17. Participant has had comparable and prolonged symptoms after other viral infections (e.g., after Epstein-Barr virus infection, influenza, infectious mononucleosis).
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Primary end point —

Main objective of the trial
To compare efficacy of BC 007 (double dose 1350 mg and double dose 1900 mg) with placebo based on fatigue symptomatic severity scale in long COVID participants.
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Merged thread

Berlin Cures Welcomes Oliver von Stein as New CEO to Lead Next Phase of Innovation and Growth

With over two decades of unwavering dedication to functional autoantibody research, we have successfully identified a biotechnology capable of effectively neutralizing fAABs.Our extensive research findings indicate that this platform technology holds immense potential in significantly alleviating or even curing a spectrum of diseases associated with fAABs, including Long COVID Syndrome (LCS), heart failure, and numerous others. By tackling the root cause, Berlin Cures emerges as one of the pioneering entities committed to addressing this critical issue.”

Phase II study for BC 007 in the indication Long COVID to start in June
Berlin Cures has received regulatory approvals to start a European multicenter Phase II clinical trial in the indication Long COVID with the molecule BC 007 and will begin the trial this June.With this important milestone in the development of BC 007 Berlin Cures will be able to obtain clinically meaningful and robust results on efficacy and tolerability of BC 007 with patients suffering from Long COVID. Initial results are expected in early 2024.

https://www.berlincures.com/en/news/new-ceo
 
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Berlin Cures has hired a new CEO:
Berlin Cures Welcomes Oliver von Stein as New CEO to Lead Next Phase of Innovation and Growth.
https://www.berlincures.com/en/news/new-ceo
Berlin Cures is pleased to announce the appointment of its new Chief Executive Officer (CEO), Dr. Oliver von Stein. He assumes the role with immediate effect and will work closely with Berlin Cures’ co-founder Dr. Johannes Müller, who will hand over his CEO duties to drive the company’s research activities as the new Chief Science Officer (CSO). Dr. Müller, an accomplished physician, researcher, and innovator, has been instrumental in the development of BC 007.
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The first patients have been given the drug:

Timo Strotman said:
Die #BC007 Studie scheint wohl wirklich anzulaufen. Erste Probanden berichten das sie eine Infusion erhalten haben (BC007 oder Placebo). Jetzt heißt es Daumen drücken und auf positive Ergebnisse hoffen!
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Translated:
The #BC007 study seems to be really getting going. First subjects report that they have received an infusion (BC007 or placebo). Now it's time to keep your fingers crossed and hope for positive results!
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Berlin Cures takes next step in battle against Long COVID
Collaboration with Uniklinikum Erlangen as 5th German research center
Berlin, Germany, 10 October 2023

Berlin Cures, a biotechnology firm specializing in the neutralization of functional autoantibodies (fAABs), is extending its collaboration with Uniklinikum Erlangen in the fight against Long COVID. As of 1 October 2023, Uniklinikum Erlangen, a recognized Long COVID research center, is participating in Berlin Cures' approval-relevant Phase II clinical trial (trial name: BLOC; placebo-controlled, 3 arms with 114 patients total), making it the fifth actively recruiting trial center in Germany, with more anticipated to follow.
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It sounds like they're going to open an additional clinical trial site in Erlangen, in addition to the ones they already have (or plan to open). Their current locations are Berlin in eastern Germany, Cologne and Münster in the west, and Vienna, Austria. I think that's a good spread and they shouldn't have trouble recruiting 114 people.
 
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