It’s been a long and winding journey, but what some would argue could be the most innovative pharmaceutical treatment for fibromyalgia ever is finally on track for a phase 2B clinical trial by this fall.

Dr. William “Skip” Pridgen, the developer of the treatment called IMC-1, is scheduled to present several funding options to his board of directors this week. Afterwards, Innovative Med Concepts, the company founded by Pridgen, is expected to commit to a new partner to help fund the phase 2B trial.

A venture capital firm and at least two pharmaceutical companies are reportedly interested in backing IMC-1, but Pridgen is mum on which path forward the leadership of Innovative Med Concepts may ultimately take.

If IMC-1 makes it to market, the drug will be unlike any other pharmaceutical treatment for fibromyalgia currently available to patients because it combines famciclovir, a common antiviral medication, with celecoxib, an anti-inflammatory arthritis drug with antiviral properties.

IBS Connection Leads to Identification of Possible Cause for Fibromyalgia

Pridgen and his team believe fibromyalgia is triggered by herpes simplex virus 1 (HSV-1). The theory that the cause for fibromyalgia is some underlying infection makes sense given the condition’s cluster of vague and fluctuating symptoms, which include chronic pain, fatigue, sleep disturbance, digestive issues, headaches, neuropathy, depression, anxiety and more. To many, that combination sounds suspiciously like an immune system response.

“It turns out, if you go back to the 1960s and 70s, there were a group of scientists and physicians who recognized a condition like fibromyalgia, and in that condition, they theorized there was some low-level infection,” Pridgen explains. “They didn’t know what it was, but … because it was ongoing, the body was constantly reacting to it, [causing the body to have] an abnormal stress response.”

Pridgen began to suspect HSV-1 is a culprit in fibromyalgia while treating patients with irritable bowel syndrome (IBS) and fibro in his Tuscaloosa, Alabama, gastrointestinal practice. He noticed the symptoms of many of his IBS/fibromyalgia patients tended to increase in severity about every three months and began to suspect there could be an infectious component to their illnesses since some viruses cycle similarly.

On a hunch, he prescribed antivirals to some of his patients to test his theory. As the months passed, he noticed the IBS/fibromyalgia patients who improved the most were also taking some sort of nonsteroidal anti-inflammatory drug (NSAID) in addition to the antiviral he’d prescribed.

“A portion of my patients, about 30%, called me up or came to see me and said, ‘I don’t know what you’re doing but I love it! My IBS is getting better, but … my pain is getting better, too,'” Pridgen recalls. “It turned out, if you took away one of the medicines, their symptoms returned. It happened like that every time, so we knew this [antiviral/anti-inflammatory] combination was the key. Our medicine hits the virus at least three different ways. We believe it forces the virus back to sleep. Once the virus is asleep again, and there’s no ongoing abnormal stress response, the body’s immune system turns around and goes back to normal.”

(This article gives a more thorough explanation of the connection between HSV-1 and fibromyalgia.)

To bolster Pridgen’s theory, a yet unpublished University of Alabama study showed the presence of a protein specific to HSV-1 in the stomach biopsies of more than 80% of fibromyalgia patients. That protein was missing from the stomachs of healthy control subjects.

“We feel this is strong corroborating evidence,” Pridgen says.

The Progress of IMC-1 Studies

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In 2017, Pridgen and his team published the results of a phase 2 “proof of concept” study in which 143 fibromyalgia patients were given IMC-1 over 16 weeks. The results were similar to Lyrica and Cymbalta, two fibromyalgia drugs currently on the market. Around 30% of patients taking IMC-1 during the trial experienced at least a 50% reduction in pain.

“A significant decrease in fibromyalgia-related pain was observed for patients on IMC-1 treatment versus placebo,” the study reads. “[Patient’s Global Impression of Change questionnaire] response rates were significantly improved with IMC-1 treatment. Overall, patient self-reported functioning … was significantly improved. Fatigue was also significantly improved as measured by the PROMIS fatigue inventory.”

Existing fibromyalgia medications are known for their troublesome side effects. However, IMC-1’s side effect profile is low, according to the study results. In fact, more people in the placebo group (16%) dropped out of the study due to side effects than those actually taking IMC-1 (5%). That rarely happens!

Although IMC-1 performed just as well as current fibromyalgia medications, Pridgen is hopeful it will do even better during the upcoming phase 2B trial. Due to U.S. Food & Drug Administration guidelines, the 2017 study used a dose that was much less than what Pridgen ordinarily uses with his patients in his practice.

During 2018-19, Innovative Med Concepts completed animal and human toxicity/safety studies for that higher dose. All of those studies came back without issue, so the new 2B trial this fall will use the exact dose of IMC-1 that Pridgen has successfully given his patients for years now.

“People come to our practice from all over the world now,” Pridgen says. “We’ve been able to get the vast majority of patients to about 85% better. That’s always our goal, and we don’t quit. We keep tweaking and tweaking until we figure out how to get them that last little bit, but it’s rare to have a patient in our practice who is put on this medicine who doesn’t at least get a 50% or 60% improvement in pain, and to date, [no other drug] is getting that kind of response.”

What’s next?

Based on the current schedule, the phase 2B trial should begin by early fall.

“We think there’ll be about 30 to 35 centers around the country,” Pridgen says. “I haven’t decided yet if we’re going to go into Canada, but that might happen.”

At this point, European and Asian countries will not be included in the study but that could change if Innovative Med Concepts’ new partner wants to go global.

For now, Innovative Med Concepts is focused on developing IMC-1 for fibromyalgia, but Pridgen believes the drug may benefit ME/CFS, irritable bowel syndrome and other conditions.

“I would not be surprised if we also started doing some phase 2 studies for some of these other indications because [IMC-1] works so well,” Pridgen says.

As more and more doctors refuse to prescribe opioids for chronic pain conditions, fibromyalgia patients desperately need more treatment options, and Pridgen hopes IMC-1 can fill that void.

“Our medicine has incredible pain-relieving qualities for those affected by fibromyalgia, and yet, it’s not a narcotic, [so] it doesn’t put patients at risk of having an overdose,” Pridgen says. “In this day and age, when every pharmaceutical company that sells narcotics is being sued by different states, and everybody’s looking for a way to properly treat these unfortunate patients who suffer from chronic pain, having a non-narcotic medicine that works and helps with this chronic pain sounds like awfully good news.”

Donna Gregory Burch was diagnosed with fibromyalgia in 2014 after several years of unexplained pain, fatigue and other symptoms. She was later diagnosed with chronic Lyme disease. Donna covers news, treatments, research and practical tips for living better with fibromyalgia and Lyme on her blog, FedUpwithFatigue.com. You can also find her on Facebook and Twitter. Donna is an award-winning journalist whose work has appeared online and in newspapers and magazines throughout Virginia, Delaware and Pennsylvania. She lives in Delaware with her husband and their many fur babies.