Pridgen- fibromyalgia

Pridgen’s effort to bring an antiviral drug combo to market is reaching its culmination. Meanwhile, he’s taking on long COVID.

Bringing a new drug combination to market is not easy. First, it requires creativity and initiative. Dr. Skip Pridgen was nothing if not creative when he put together a two-drug combo antiviral (valacyclovir) and an anti-inflammatory with antiviral properties (celecoxib) to fight fibromyalgia – a disease that virtually no one had connected to herpes viruses.

Not only that but he focused on a herpes virus – herpes simplex – that no one had thought seriously about in 30 years in either FM or its sister disease – chronic fatigue syndrome (ME/CFS). Plus, he employed a strategy that I had not seen before in ME/CFS – using two drugs to inhibit the virus at different points in its replication cycle to stop it from replicating. (The same general strategy is used to treat HIV.)

He showed initiative by raising $3 million for the first trial and enrolling top talent from Pfizer and other drug companies. He showed staying power by making it through the “Valley of Death” – the treacherous period between the stage 2 clinical trials and the stage 3 clinical where tens of millions of dollars need to be raised. (He expects the third and final stage of clinical trials for fibromyalgia to begin soon.)

Now he’s onto long COVID. As ever, he remains supremely confident in the ability of his drug combo to produce results.

Pridgen’s (First) Long-COVID Trial

Once again, he’s breaking new ground. While there’s been a lot of talk about herpesvirus reactivation in long COVID, this is the first clinical trial I’ve seen that is actually going after it.

Pridgen’s entry into the long-COVID field is really no surprise. He’s always believed herpesvirus reactivation plays a major role in the ME/CFS/FM spectrum of diseases. His provisional patent from over a decade ago proposed his protocol would work for a wide variety of poorly treated diseases including ME/CFS, irritable bowel syndrome, chronic pain, chronic headache, chronic neck pain, chronic back pain, chronic depression, chronic clinical anxiety disorder, post-traumatic stress disorder (PTSD), brain fog, cognitive dysfunction, and chronic interstitial cystitis. A published case report suggest his protocol might work for some migraine patients.

The Pridgen Protocol for Fibromyalgia – Could It Work in Migraine? A Report Suggests Yes

While Pridgen’s two-drug approach and his virus of choice are different, his general conception of the disease is not. He and his partner, virologist Carol Duffy, believe the bodies of people with fibromyalgia, ME/CFS, long COVID, and others, are overreacting to a virus that almost all of us carry.

“It’s basically exaggerating its reaction to the virus. Any little stress reactivates the virus, and, rather than the body saying, ‘Oh, this is just a virus I’ve been living with this since I was five,’ the body keeps saying, ‘Oh, my God,’ and throws on all this inflammation, and that gives these people this pain. There is a theory that all pain, one way or another, is inflammation. It’s inflammation gone awry.”

(That was ten years ago. Note that Pridgen has also found evidence of higher levels of herpesvirus reactivation in the stomachs of FM patients.)

He told me, “I am having excellent success treating long COVID and Cindy Bateman’s research (Bateman Horne Institute) has replicated my results.”

No papers have been published, but last month his company, Virios Therapeutics, reported the results of a pilot long-COVID trial done at the Bateman-Horne Center. Twenty-two female long-COVID patients getting the drug for 14 weeks were matched with 17 female patients being treated by either Dr. Bateman or another healthcare provider. The open-label trial meant that everyone knew what they were getting.

The patients getting the drug combo received “clinically and statistically significant improvements in fatigue, pain, and symptoms of autonomic dysfunction and general well-being related to Long-COVID”.

In ‘VIRI: Encouraging Results For IMC-2 In Long COVID…“, Zacks/SCR indicated that the improvements in fatigue were quite substantial. While the control group – which was being treated by other means – improved by only -0.34 on the PROMIS Fatigue score, the Pridgen protocol group improved by -7.24. 

Fatigue scores

Note the dramatic differences in the fatigue scores between the antiviral and the non-antiviral treated groups.

If, as the report stated, a decrease of 3.0 or greater is considered enough for the patient to have experienced a “noticeable effect”, the effect these patients must have experienced was likely “very noticeable”. That reduction in fatigue suggests that a major impact on functionality – the most distressing symptom for many people with these diseases – may be possible. 

Similarly, while the orthostatic (standing) symptoms of the usual treatment group appears to have actually gotten worse, the antiviral-treated group got better.


orthostatic symptoms

While the usual treatment-long COVID group appears to have gotten worse the antiviral treated-long COVID group appears to have received a substantial benefit.

Virios pointed to the wide range of benefits seen in the long-COVID patients.


  • Dr. Pridgen’s attempt to bring a two-drug treatment regimen to market for fibromyalgia is into its 10th year, but he’s already moving into long COVID. This is no surprise, as ten years ago his provisional patent proposed the antiviral treatment regime would work for all sorts of illnesses including ME/CFS and irritable bowel syndrome.
  • Pridgen’s assertion that reactivated herpesviruses – in particular, herpes simplex viruses – are causing fibromyalgia is notable given that herpesviruses have received almost no attention in FM over the past 30 years, and herpes simplex virus has been ignored in chronic fatigue syndrome (ME/CFS),
  • Despite the many findings of herpesvirus reactivation in long COVID, Pridgen’s is the first effort that I know of to go after them.
  • His company, Virios Therapeutics, recently released the results of a pilot study done at the Bateman Horne Center that included 22 long-COVID patients treated with the antivirals and 17 long-COVID patients who got regular care for 14 weeks.  It was an open-label study – meaning that everyone knew what they were getting.
  • The results were surprisingly good given the small size of the study. The patients getting the drug combo received “clinically and statistically significant improvements in fatigue, pain, and symptoms of autonomic dysfunction and general well-being related to Long-COVID”. The improvements in fatigue were particularly notable.
  • Virios Therapeutics was clearly happy with the results and called the wide range of outcomes which reached statistical significance “highly encouraging”. Given the exploratory nature of the trial and the fact that it was “not powered to show significance” (which it clearly did), the company called the results “all the more impressive”.
  • The path forward for fibromyalgia is a bit murkier. When one cohort of an FM phase II study received excellent results, another one did not. A deep dig into the stats revealed that FM patients who had been in past clinical trials (“experienced”) did not do well in this one.
  • That’s a pattern that’s apparently been seen before in depression and other illnesses. Henceforth, Virios will focus on FM patients new to clinical trials and use dedicated research centers to do its trials.
  • While it’s unfortunate that all FM patients do not appear to benefit equally, Virios thankfully did not say that FM patients who had been sick longer or who had more comorbidities benefitted less. Dr. Pridgen reported that the big – and apparently determinative – Phase III trial in fibromyalgia is expected to begin shortly.
  • Meanwhile, the results from a larger Tonix pharmaceuticals fibro-long COVID study are expected soon. Tonix is also in the last stages of its fibromyalgia trial.
Virios was clearly happy with the results and called the wide range of outcomes which reached statistical significance “highly encouraging”. Given the exploratory nature of the trial and the fact that it was “not powered to show significance” (which it clearly did), the company called the results “all the more impressive”.

The usual warnings apply – this was a very small study that was not placebo-controlled or double-blinded. We’ve seen good results in small studies tumble before as the studies scaled up. Pridgen and company have successfully shepherded their drug combo through thick and thin in FM so far – but it hasn’t been easy.

Murkier Path for Fibromyalgia

There was the less-than-scintillating first study which was hampered by the FDA’s restrictions on dosage. Then there was another trial where the primary endpoint – pain reduction – was met by one of the cohorts but not the other. Digging deeper into the stats revealed something interesting – FM patients who have been through clinical trials or were enrolled in a research database before did not receive statistically significant benefits, but FM patients new to clinical trials received both “clinically and statistically significant reductions in pain, fatigue, FM symptoms, and both anxiety and depression symptoms”.

Virios noted that this pattern has been seen before in clinical trials of depression and other illnesses where “experienced” patients do not do as well as “inexperienced patients”. Virios suggested that given the 8 treatment trials over the past decade, the FM community may be reaching a saturation point in the U.S. “whereby experienced trial subjects and those presently treated for FM may be characterized as becoming more refractory (less likely to respond) to therapy.”

They’ve also found that using study sites that do clinical trials as well as treat patients is not as effective as using “dedicated” research sites with more expertise that solely do clinical studies. They’re going to stick with dedicated research sites in the future and screen out patients with “a recent history of treatment failure or patients who have previously participated in FM clinical trials”.

One would hope that everyone would benefit from the drug combo, and his past studies have not had to exclude patients in the way the next one will, but in an industry where 90% of clinical trials for drugs fail, you do what you need to do to maximize your results.

Since the analysis did not mention duration or comorbidities – which presumably it looked at – hopefully being sick longer or having a more complicated disease picture is not necessarily an issue.

One also wonders about the effect that mood or depression may have had on treatment efficacy. There are Fred Friedberg’s ME/CFS “Uplift study” (blog coming up), many mind/body recovery stories, including Patrick’s recent one on Health Rising, the recovery stories Raelan Agle features on her YouTube site, and the dramatic physiological, psychological, and functional benefits that Donna Jackson Nakazawa – a person with a severe autoimmune disease – received from a year of mind-body work. (See Health Rising’s book series here) – all suggest that mind/body work might be a good adjunct to other treatments.

My Recovery Journey from Myalgic Encephalomyelitis / Chronic Fatigue Syndrome (ME/CFS)

Tonix Long-COVID Trial Underway

Pridgen isn’t the only FM drug maker looking into long COVID. The results from Tonix’s larger (30-site!), 14-week, phase II study focused on fibro-long COVID are expected in shortly. Tonix believes approximately 40% of long-COVID patients meet the criteria for fibro-long COVID. Perhaps looking ahead to an ME/CFS trial, the company noted that the same symptoms in long COVID occur in ME/CFS as well.

“Common symptoms of Long COVID, including multi-site pain, fatigue, unrefreshing sleep, and cognitive dysfunction, or ‘brain fog,’ are also hallmarks of conditions like fibromyalgia and chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME),”

Its TNX-102 drug – which the company states reduces both pain and sleep – is in its final phase of study in fibromyalgia as well. Results are expected in the last quarter of this year.

Tonix Launches Decisive Fibromyalgia Treatment Trial Plus Big Year for Fibromyalgia Drugs?

Next Steps

With these results in hand, Pridgen reported that Virios has raised the funds for a Phase 2 double-blind placebo-controlled long-COVID study and is applying to the FDA to get it started. Because Pridgen and company have already done extensive toxicology studies, the process should be quicker for long COVID than for the fibromyalgia application – which is already in its 10th year.

With regard to fibromyalgia, Pridgen is simply waiting on FDA approval – which could come any day – to get the OK to do its big – and determinative – Phase 3 FM study.


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