It’s not too much to say that if successful, the Pridgen antiviral trials for Fibromyalgia would be a paradigm changer – turning FM from a poorly treated central nervous system disorder to a disorder characterized by a (hopefully) treatable herpesvirus infection.
Pridgen’s approach is new in several ways. Not only has no one targeted herpesviruses in FM before, but the herpesvirus Pridgen is targeting, herpes simplex virus, is one no one has connected with either FM or ME/CFS before.
Pridgen has also combined an antiviral with an anti-inflammatory (with antiviral properties). Rumors have abounded regarding the identity or identities of the drugs, but we won’t know officially which they are until the report is made.
The fact that we haven’t had a press release by now regarding the Phase II trial has lead to some concern. (Phase two trials are typically larger trials (1-several hundred people) that further assess a treatment’s efficacy and safety. Pridgen’s Phase II trial was a large multi-center trial.)
I contacted Dr. Pridgen to see what he could say at this point. This is what he said.
- They hope to present their research mid-Nov
- A press release will predate that
- The treatment was statistically significantly effective in improving nearly every primary and secondary endpoint
- The treatment was significantly superior to placebo (p<.oo1) (not sure which endpoints)
- The treatment was better tolerated than placebo
- The results in the FM trial are good enough that preliminary plans are being made for toxicology studies that will allow them to move forward on a similar Proof of Concept Phase 2 CFS (ME/CFS) trial; i.e. they’re beginning to work on a similar ME/CFS trial.
- They will be looking for government/humanitarian funding for that.
The Earlier Video
Check out a confident Dr. Pridgen as he talks about the Fibromyalgia trial sometime around April at a local news station.
It’s going to take longer for the final results than many had hoped but the news otherwise is good. The significant improvement in almost all the endpoints is promising (and I would say somewhat unusual). The fact that they’re beginning preliminary planning for an ME/CFS trial suggests that the FM trial went well indeed.
Still, we won’t know how significant the significant improvements are until the press and study release probably in November.
That will be frustrating to those who want to get going on treatments now, but my understanding is that this period – prior to publication – is a delicate period in the development of any drug. If that’s true think how much more so it is for a startup company that’s going to need to raise significant funds for the big Phase III trial. Publicly releasing the full results and the drug combo they’ve identified this far in advance of publication would be a mistake.
For more on Pridgen’s antiviral trial check out