Do we know why they have this one-year requirement? I mean they have a control group that only gets placebo, so I don't think they are planning to attribute the effect of the drug to the potential early natural recoveries. Do they believe the condition is a lot less likely to be reversible after the first year or why? Edit: my speculation: maybe of the patients they tried it on before the trial, only the ones who were ill for less than a year recovered? Which might point to the spontaneous early recovery known in ME/CFS. But maybe their interpretation is that the drug works better in the early stage. Just my speculation though.
Tagesspiegel, 2024-02-09: Long-awaited active ingredient against Long Covid: Participants wanted for study with BC 007 (Interview with CEO of Berlin Cures, Oliver von Stein) Paywalled.
This is further discussed on Reddit, including a complete translation of the interview: BC007 Interview on trial progress
Berlin Cures Expands Research Capabilities and Scientific Expertise with New Advisory Board https://www.berlincures.com/en/news...-expertise-with-new-advisory-board-2024-04-03 includes well-known names such as Scheibenbogen and Mardin.
Estimated study completion date moved up from 2025-05-31 to 2024-11-30. Follow-up period reduced from one year to 90 days. Added this to inclusion criteria: ClinicalTrials.gov
Supposedly this means they have some positive preliminary results, whatever that may actually mean, as I really don't see how it could be able to show a use given the failures of Rituximab and Efgartigimod and all studies finding no relevance of these aabs.
That would be possible. But the again Efgartigimod trial was targeted at POTS and the BC007 didn't really look at any subtypes of LC, for instance neurological LC, or anything of that sort and the sample size wasn't too massive to really untangle any subtypes. We'll definitely have to wait for the data but it's certainly still possible that they interpreted the trial as positive given high natural recovery rates in the first few months of LC (not sure how they would have done that given they had a control group, but that data will have to be looked at). From what I recall the LC studies looking at GPCR aabs, without finding much, have also been fairly general and not only focused on ME/CFS (for instance Iwasaki's study). Of course it's also possible that the drug worked in some different way, who knows, but they would anyways not have any data to show that. I guess Rituximab also showed positive phase 2 data, but still ended up failing and showing no efficacy...
In the early days they were talking a lot about bc007 improving red blood cell deformities and increasing tissue oxygenation or something along those lines. So perhaps its to do with that. Or perhaps the autoantibodies are somehow relevant even though the levels aren't associated with ME/LC. Efgartigimod wasn't precisely the same mechanism, was looking at POTS and there were enough patients that felt significantly better in that trial that they've got together to ask Argenx to release the full data for study. Which of course could be the high early recovery rate again. Or perhaps the BC007 trial has just failed.
The big reduction in the follow-up period suggests that might be the case. When we find something that really helps, the emphasis is more likely to be on extending the follow-up period to see how long benefit is sustained.
Yeah I hope you're wrong but it seems like a distinct possibility. Unless they have found it helps but it's not a one and done thing like they claimed? Like monthly or whatever infusions needed and they want to move on to phase 3 faster. Or they just want to move onto phase 3 asap and do the follow up stuff there.
I suppose if they got an excellent response in a high proportion of participants there might be an ethical argument for moving quickly to Phase III, but presumably they'd have to have the funder on board with it. I imagine it'd be less likely to wash if they needed new funding for Phase III. Funders will look at how they've conducted the groundwork, and cutting the follow-up period by 75% looks iffy—specially if the team hasn't already got an established relationship with them.
