Wirth and Sheibenorgen hypothesise in their new paper (Pathophysiology of skeletal muscle disturbances in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome) that beta 2-adrenergic receptor dysfunction is of critical importance in the pathophysiology of ME/CFS, in causing vascular dysregulation, so BC 007 may have some potential for ME/CFS also. https://translational-medicine.biomedcentral.com/articles/10.1186/s12967-021-02833-2
My question is, it seems that only a subset of ME/CFS patients are positive for these autoantibodies (https://pubmed.ncbi.nlm.nih.gov/26399744/), does this mean this medication would only be helpful for those individuals?
Frankly 800K for a drug trial is not warranted at this point.
They can start with feasibility studies which cost very little and a phase one trial would not cost much either from an established scientist.
Pass it as a phase 3 for covid long hauling so its got its safety certificate and then the moment you start selling it privately you'll have your ME/CFS trial to work out if that 800k to complete the trial process is worthwhile, there will be zero need to raise that from patients there will be ample evidence of future prospect for the drug.
BC007 takes out certains specific autoantibodies (the immune system attacking receptors in the body).
The whole point of BC007 is to take out these antibodies without affecting other antibodies.
That means, if Rituximab didn't work, BC007 can't possibly work. But if it does, it doesn't wipe out the rest of the immune system, like Rituximab does.
There is little point in raising 800 000 USD for this trial, as the major hurdle is selecting patients, not removing the antibodies, which can simply be done with Rituximab or even cheap steroids. Why don't we use steroids for ME already? Because of those with ME due to a different cause, such as infections or NO overproduction. These would worsen.
Verification and increasing availability of the antibody tests, should be done before testing this treatment. What is the point of making this treatment approved, if no one can get it, because tests to select patients are not available?