Long Covid drug BC-007 research news

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.

 

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.

 

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?

 

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.

 

Precisely sums up , thank you - "---we have no treatments---". We need research (such as GWAS) to identify the cause/underlying disease mechanism --- then we can move to treatments.

 

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

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.

 

https://twitter.com/user/status/1636618123682930689

 

Do they only expect it to work in the early stage?

 

https://www.clinicaltrialsregister.eu/ctr-search/trial/2022-003452-14/DE

As noted by @Wyva, inclusion criteria include —

Exclusion criteria include —

Primary end point —

 

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

 

That's really good news. The trial application specifies 114 participants. I'm very happy about that.

 

They're now on Clinicialtrials.gov:
To Investigate Efficacy, Pharmacodynamics, and Safety of BC 007 in Participants With Long COVID (BLOC)

They say they started on June 16. They're recruiting in 4 locations: 2 in Berlin (including Charité), 1 in Cologne, and 1 in Munster, and one in Cologne.

 

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

 

The first patients have been given the drug:
https://twitter.com/user/status/1676600658680590336

Translated:

 

First study with long-Covid drug also starts in Austria

Long Covid can be a disease with high levels of suffering for those affected. There is no reliable therapy. For this reason, great hopes are placed in the preparation BC007. A first study is now also starting in Austria.

https://www.kleinezeitung.at/lebens...mit-LongCovidMedikament-startet-in-Oesterreic

 

Berlin Cures takes next step in battle against Long COVID
Collaboration with Uniklinikum Erlangen as 5th German research center
Berlin, Germany, 10 October 2023

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.

 

The inclusion criteria for this study are making it very hard to recruit. Machine translation of the tweet:

https://twitter.com/user/status/1738124676537164012