Dr. William Pridgen ▲

A Tuscaloosa company behind a revolutionary approach to treating a debilitating disease is nearing its final trials.

Innovative Med Concepts is preparing for one of two final Federal Drug Administration trials for what it has named IMC-1, a drug that in prior tests has shown significant effectiveness in combating the effects of fibromyalgia.

Tuscaloosa surgeon Dr. William "Skip" Pridgen of Tuscaloosa Surgical Associates is the CEO of Innovative Med Concepts, a company that he and others formed in 2012 after he discovered that a combination of two existing drugs was having a profound effect on sufferers of fibromyalgia and irritable bowel syndrome.

"The two medicines together do something that individually the components would never do," Pridgen said.

This medicinal recipe, a specific combination of famciclovir and celecoxib, has now been patented and subjected to numerous FDA-required trials.

The most recent trial, Pridgen said, showed that IMC-1 provided greater pain and symptom relief than other fibromyalgia and pain relief medications currently on the market, including Lyric and OxyContin, while more patients taking a placebo reported unwanted side effects – and subsequently dropped out of the study – than those on the medication itself.

"It had a huge signal, meaning it was affecting everything," Pridgen said, explaining that IMC-1 was helping to alleviate pain, depression and fatigue, among other symptoms commonly associated with fibromyalgia.

And with more than 68,000 people dying from drug overdoses in 2018 alone, IMC-1 is accomplishing this level of success without being an opioid or narcotic that is susceptible to abuse and overdose.

"We're fixing the underlying problem," Pridgen said. "We're not just trying to mask the pain."

Named in the 1970s, guidelines for diagnosing and treating fibromyalgia weren't developed until 1990. Even then, it took until 2007 for the first drug to be manufactured in an attempt to treat it.

Pridgen said the estimated 8 million to 10 million Americans who are suffering from the condition – most of whom are women with an average age of 49 – feel like they're constantly "being chased by a tiger, as the body's immune system works around the clock to combat a common and dormant virus that is now awakened.

The causes for the disease still remain a mystery, but Pridgen theorizes that it is triggered by active herpes viruses within the intestinal tract.

The son of a surgeon father and virologist mother, Pridgen took his idea that fibromyalgia was caused by this virus to his mother after noticing that a combination of drugs was yielding better results in his patients than just one of the drugs alone.

This is a virus we all have, he said, but some kind of stressful situation – a divorce, a sudden or painful death in the family – serves to push the patient "over the edge," thereby activating the virus and forcing the body to attack it.

With each successful trial of ICM-1, many of the mysteries surrounding the causes of fibromyalgia are being removed as Pridgen's theories prove correct.

"What we've done is clarified so much that was cloudy in the past," Pridgen said.

Innovative Med Concepts has raised about $16 million to complete these initial trials, and Pridgen said he expects it will take at least $48 million to $50 million to fully complete the tests, gain FDA approval and have the drug on the market.

While this level of investment in what, as of now, remains an unapproved medical product is high, it is far less than the $560 million industry average that Pridgen said it typically costs to bring a new drug to market.

So far, Innovative Med Concepts has been able to generate the funding it needs through friends and family. But that trend may soon end as the company hosts meetings later this month with potential investors.

Pridgen said the company also has been in discussions with pharmaceutical companies and investment banks about potentially licensing or buying Innovative Med Concepts if, or when, IMC-1 is cleared for medical use by the FDA.

Much of this remains undecided, but Pridgen said that the drug could be on the market by 2023, if all goes according to plan.

Until then, he intends to keep doing what he's been doing since 2012: Working toward making IMC-1 a reality.

"It's really remarkable. It doesn't work on everyone, but it works on most everyone," Pridgen said. "But I feel like we can see the light at the end of the tunnel and this is going to happen."

Reach Jason Morton at jason.morton@tuscaloosanews.com or 205-722-0200.