This drug will probably fail. The spike protein causes LC symptoms theory is dubious because:
- Many LC sufferers don’t have spike protein when researchers try to find it.
- People will have crazy amounts of spike protein in their system when they catch COVID. But they don’t have LC symptoms because of that.
What the drug is
Bezisterim NE3107 is an orally bioavailable, BBB-permeable, insulin-sensitizer that is also anti-inflammatory. In addition, it is not immunosuppressive and has a low risk of drug-to-drug interaction. Bezisterim has the potential to reduce symptoms of long COVID, including fatigue and cognitive dysfunction. Persistently circulating viral spike proteins are believed to trigger TLR-4 driven activation of NFkB and the subsequent expression of inflammatory cytokines (IL-6, TNF, IFNg). NE3107 has been shown to modulate the activation of NFkB and thus modulate inflammation
Press release describing drug: News Release
Enrollment page: Long COVID Clinical Study | BioVie Pharma
The TLR4 activation → NFkB → cytokines theory
The press release above describes the theoretical mechanism of action. But…
Different groups have measured the IL-6 cytokines in Long COVID patients (e.g. IncellDX / Bruce Patterson) and ME/CFS patients. That research looks like a flop. Patients don’t seem to have a unique cytokine signature.
Activation of TLR4: The TLR4 pathway is one pathway that causes activation of your immune system. This can happen with many infections- because your body is designed to fight off infections. Mammals have many different ways of fighting off infections and researchers can study that in mice where their genes have been altered to turn off immune system pathways.
The TLR4-activating infections don’t seem to cause a Long COVID-like illness. So… I’m not sure the theory makes sense.
But pharma gonna pharma: There is a tendency for small startup biotech companies to keep chasing failed ideas so that they can raise more money for the company. More money coming in means that the people running it make money (e.g. from salaries).