Long Covid drug BC-007 research news

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.
 
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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.

How did you change the criteria?
Originally, we had only planned to include test subjects who had been infected with Covid for a maximum of one year. With the approval of the German drug authority BfArM, we can now extend this to include people with long Covid who were infected longer ago. Also newly included are patients who have a stable chronic illness that has nothing to do with the new Long Covid symptoms. These include diseases such as diabetes or glaucoma. However, serious secondary diseases such as cancer are still excluded.
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If you can complete recruitment for the trial by May as planned, when do you expect to see the results of whether BC 007 is effective against Long Covid?
If we can maintain the pace of recruitment and reach the required number of participants, I assume that we will have the first results in fall 2024.
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Even if this phase 2 trial is successful, there is still a long way to go before a drug is available to patients. This is because there would have to be an approval, i.e. phase 3 trial. This would be significantly more extensive than the current one and correspondingly more expensive.
We are looking for additional investors or cooperation partners for this approval study. The costs are in the high double-digit million range. For a small company like Berlin Cures, this can no longer be financed solely with funds from current private investors. Some additional investors have already been found, but more are still needed.

The search is challenging as long as you don't have an approved drug or at least a successful phase 2 trial. However, as I am very confident that we will soon be able to present a success, the search for investors will hopefully be much easier afterwards.
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  • 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:
Concomitant treatment may be permitted, if
  • A treatment (type and dose) remained unchanged within the 2 months before the start of Screening.
  • No change in treatment is expected or required between Screening visit and Day 30 of the study.
  • A treatment does not affect any of the study assessments, in particular by (e.g.,) causing fatigue or by impairing concentration ability.
As judged by the Investigator and after discussion with the medical monitor, possible allowed concomitant medications include but are not limited to:
  • Antihypertensives (β-blockers are NOT allowed)
  • Lipid lowering agents.
  • Antidiabetics (insulin is NOT allowed)
  • Thyroid hormone replacement.
  • Topical treatments.
  • Low dose acetylsalicylic acid (up to 100 mg/day).
  • Ivabradine.
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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.
 
EndME said:
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.
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Possibly in relation to other subtypes of long covid that aren’t ME/CFS.
 
Yann04 said:
Possibly in relation to other subtypes of long covid that aren’t ME/CFS.
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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...
 
EndME said:
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...
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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.
 
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.
 
V.R.T. said:
Or they just want to move onto phase 3 asap and do the follow up stuff there.
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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.
 
Berlin Cures Welcomes Renowned Immunologist Professor Danny Altmann to its Advisory Board

Press release said:
Altmann, a distinguished immunologist from the Imperial College London, will bring invaluable expertise to the company’s drug research and development efforts focused on autoimmune diseases, including Long COVID.
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Berlin Cures, a biotechnology company specializing in the neutralization of functional autoantibodies (fAABs), is currently conducting a Phase II clinical trial with its drug candidate BC 007 (Rovunaptabin) in patients with Long COVID. Initial results are expected in Q4 2024. Berlin Cures has already completed a Phase IIa study with BC 007 in heart failure, showing long-term neutralization of functional autoantibodies after a single dose.

Berlin Cures is currently actively seeking financial partners to fund a potential Phase III trial as soon as possible after a positive Phase II outcome. A subsequent successful Phase III trial would be the prerequisite for obtaining market approval for BC 007.
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Berlin Cures will reveal the results of the BC007 Phase II trial in November at a Long Covid conference.

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."

I don't think you send the CEO if the results are bad! I started very skeptical on BC007 but I will listen with interest and gee I'd love to find out I was wrong to doubt them.
 
Murph said:
I don't think you send the CEO if the results are bad! I started very skeptical on BC007 but I will listen with interest and gee I'd love to find out I was wrong to doubt them.
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Indeed :)

This, fingers crossed, will be interesting.

I've not delved into this for some time so I'm hoping they are using objective outcome measures? :)

I hope it gives patients and their doctors some hope.
 
Primary outcome measure is a fatigue scale

"To compare efficacy of BC 007 (double dose 1350 mg and double dose 1900 mg) with placebo based on Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale in long COVID participants.

FACIT-F is a five-point scale from 0 (not at all) to 4 (very much). The maximum composite scale is 52 (range 0 to 52). Higher scores mean a better outcome."

The trial is double blinded so not such an issue; however, real world changes need to be demonstrated, for example, return to work (or equivalent) etc.
 
Full news release

"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."
 
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