BC-007: Successful drug against Autoantibodies helps with long COVID

[SWAlexander]

Translation:
Difficult day today. Laboratory result: No GPCR antibodies detectable. As with 2/3 of all those affected! I am therefore now withdrawing from the #BC007 study offered.
This also means: Even after approval in the distant future, BC007 will not be able to help me. Hope very decimated today.

original link:

https://twitter.com/i/web/status/1773421164901126645

 

[Hufsamor]

I’m sorry

 

[tcamde]

New press release from Berlin Cures:

- 75% of patients now enrolled in BC007 study
- Prof. Scheibenbogen of Charite University Hospital joins advisory board

https://www.berlincures.com/en/news...-expertise-with-new-advisory-board-2024-04-03

 

[kushami]

Press release 23 April 2024 stating that recruitment is complete:
https://www.berlincures.com/en/news...07-phase-ii-trial-for-treatment-of-long-covid

No particular reason to read it.

It does mention first results possibly coming out in autumn 2024, which would be Southern Hemisphere autumn, which isn’t far off now.

 

[rmbotica]

Press release 23 April 2024 stating that recruitment is complete:
https://www.berlincures.com/en/news...07-phase-ii-trial-for-treatment-of-long-covid

No particular reason to read it.

It does mention first results possibly coming out in autumn 2024, which would be Southern Hemisphere autumn, which isn’t far off now.

21 November 2024
https://www.berlincures.com/en/news/demystifying-long-covid-interntaional-conference-2024

"Dr. Oliver von Stein, CEO, and Dr. Axel Mescheder, CMO, will represent Berlin Cures at the event and will present the latest results from a Phase II trial of BC 007 in Long COVID patients. Prof. Danny Altmann, immunologist from Imperial College London and member of the Advisory Board of Berlin Cures, will also be attending."

 

[tcamde]

The BC007 trial has failed and Berlin Cures is shutting down

Here is the official press release:


Topline results of Phase 2 Long Covid trial do not show evidence of superior efficacy of BC 007 over placebo arm

Berlin, Germany, 13 November 2024

Berlin Cures AG informs about the status of topline results of BC 007 in Long Covid from the randomized and double-blind Phase 2 trial, which has been conducted by its affiliate Berlin Cures GmbH.

The analyses of the main endpoints did not show evidence of superior efficacy of the BC 007 treatment arms over the placebo arm. The data do suggest, along with previous trials, that BC 007 is safe and well tolerated.

Further in-depth analyses have not been conducted. Due to financial constraints, Berlin Cures GmbH was forced to stop all activities.

Berlin Cures would like to thank all the patients who participated in the trial, the physicians and clinical trial sites and its supporters who have made it possible to conduct the clinical Phase 2 trial.


https://www.berlincures.com/en/news/phase-2-long-covid-results

 

[kushami]

What a shame!

Thank you, @tcamde, for posting the news.

 

[kushami]

I am sure the people who ran the study learned a lot about Long COVID and hope they will be able to use that knowledge in further endeavours.

Thank you to everyone who participated, too.

 

[cfs since 1998]

Well, this is obviously terrible news.

I'm guessing this is the trial they were talking about:
https://clinicaltrials.gov/study/NCT05911009?intr=bc007&rank=3#study-plan

Two infusions for two weeks with primary endpoint measured at 30 days? That's it?

Looks like there will be no second chances with the company shutting down...but had they consulted ME/CFS experts I'm sure they would have been advised to do a 6-12 month trial, not 30 days. May be a missed opportunity here. Bad study design.

 

[JES]

It is bad news, but this is unfortunately not unexpected. How many drugs have been trialed for Alzheimer's without success? MS? Unfortunately biomedical research is difficult and expensive. This is why the whole nonsensical BPS approach exists - because it's easier and cheaper to do that kind of "research".

For there to be a successful drug, I expect it would take at least dozens of trials and quite likely we also need to divide patients into subgroups before doing the trial since the wider range of symptoms, the more regression towards mean (placebo) seems to happen with treatment effect. If there was a way to divide patients based on some measured parameter in the blood for example, then it would be more straightforward to define subgroups no doubt.

 

[ruben]

Maybe AI will assist us, and speed things up in due course.