BioVie Awarded up to $13.1 Million in Funding from U.S. Department of Defense to Evaluate Bezisterim (NE3107) for the Treatment of Long COVID

Post copied from News from the USA

The Department of Defense has "announced the approval of a clinical trial award of up to $13.1 million from the U.S. Department of Defense (DOD) to evaluate Bezisterim (NE3107) for treating neurological symptoms associated with long COVID." The funding is going towards a private pharma company.

The trial will start in early 2025 and will include 200 patients over a three-month period.

In terms of mechanisms - "Bezisterim, an anti-inflammatory and insulin sensitizer that crosses the blood-brain barrier, targets the underlying mechanisms believed to drive long COVID symptoms, including chronic inflammation and metabolic dysregulation."

Full article:
https://www.proactiveinvestors.com/...defense-for-long-covid-treatment-1046368.html

 

Merged thread

https://finance.yahoo.com/news/biovie-awarded-13-1-million-120000499.html

 

https://en.wikipedia.org/wiki/Bezisterim

 

This project is supported by The Assistant Secretary of Defense for Health Affairs endorsed by the Department of Defense, in the amount of $499,200 for the planning phase with an option to execute the $12,6 million clinical trial after the planning phase has concluded, through the Peer Reviewed Medical Research Program under Award Number (HT9425-24-1-0300).

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.​

 

I can’t find anything about a phase 1 trial? Can they go straight to phase 2, is that a thing?

 

Interesting that DOD is funding this instead of NIH.

 

I remember reading quite a few “Functional Somatic Syndrome” studies funded by the DOD which included ME/CFS. Happy they are now funding the biomedical route.

 

If a drug has been tested in human clinical studies before, going straight to phase 2 makes sense and there is nothing to say you cannot. It also makes sense if you do not have any clear pharmacodynamic measures to look at in a phase 1. If you don't quite know how the drug is supposed to be working in the new context then a phase 2 efficacy study is about all you have to move forward on.

 

Perhaps the most relevant point.

 

I think DOD is probably more flexible in what they can fund—whereas NIH is probably tied down to funding the same types of research they always fund. In other words DOD is less risk averse. I’ve heard this before.

 

The US army has a loooot of people on active or reserve duty and lots more in veterans affairs. On top of a huge number of civilians in the administration and support side of things. Even something with a 1-2% prevalence can have a lot of impact if it's fully disabling, requiring lots of complex health care. Mostly in that it's very expensive.

I don't mind if this gets solved because someone finds it too expensive to ignore, even though it'd be ironic considering that we have been ignored because some people thought it would be too expensive to acknowledge and treat it. Which turned out to make it massively more expensive. But for a short while it probably looked less expensive if you simply didn't bother looking at future costs. Or didn't mind committing to an immoral disaster.

Big shade of "if you think education is expensive, wait until you find out how expensive ignorance is". Humanity has probably already wasted 100-1000x the cost of solving it completely already, and it just keeps adding up. All it takes is for smart people to look at the running bill who can make the argument that it would obviously be cheaper to stop it from running up indefinitely.