Virios (NASDAQ: VIRI) stock is up 40% premarket this morning on news that the FDA is being nice about the company's fibromyalgia treatment. It has to be said that it's not being that nice about it - the information release is simply that the Phase III proposal is acceptable. But even that's a bit of a surprise given what happened back in September last year. Which was that the entire development program was thrown into entire disarray as the Phase II results came back.
The basic idea of what Virios has been developing is “The FORTRESS study, designed to evaluate oral IMC-1 antiviral therapy against placebo, enrolled 425 female fibromyalgia patients aged 18 o 65. A candidate with the FDA's fast track designation, IMC-1 is a combination therapy consisting of famciclovir and celecoxib designed to suppress herpes virus replication to reduce virally driven disease symptoms.” if herpes s the driver, you reduce the replication, then you should be able to reduce the pain. Sadly, the results were that there was no statistically valid reduction in paid reported. So, that was a bit of a blow, the VIRI stock price dropped from $8 or so to $0.50 - yes, 50 cents.
Virios stock price from NASDAQ
However, unlike most such testing failures that wasn't the end of the road. One viral infection will be affected, often enough, by another. And they were getting different results in different stages of covid. When Delta was prevalent then there was no pain relief. When Omicron there was. So, maybe it's the interaction of covid - type of covid - herpes and the treatment that matters. Thus further investigation is warranted. And it's that which the FDA is being nice about no
We do think it's desperately unlikely that the stock is going to go back to $8 in the short term. An actual treatment for fibromyalgia that provably works and has FDA approval, then yes and perhaps. But before then? Our best guess is that dreams once dashed won't return until there's actual proof rather than just hope that there might be.
