This article was originally published on Prohealth.com and is being reprinted here with permission from the editor.
On July 18, 2020, Dr. Skip Pridgen provided the following update on the trial: “We anticipate having all the necessary funds by November and will begin the trial by March 2021.”
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, was scheduled to present several funding options to his board of directors this month. Afterwards, Innovative Med Concepts, the company founded by Pridgen, will 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 will ultimately take.
If IMC-1 makes it to market, the drug will be unlike any other pharmaceutical treatment currently available to fibromyalgia patients because it combines famciclovir, a common antiviral medication, with celecoxib, an anti-inflammatory arthritis drug with antiviral properties.
Pridgen and his team believe fibromyalgia is triggered by herpes simplex virus 1 (HSV-1). The theory that fibromyalgia is caused by 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,” Pridgen explains. “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 first IMC-1 study
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 drugs 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.
“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.”
Now it’s your turn: What do you think of Dr. Pridgen’s theory? Are you interested in trying IMC-1? Share in the comments!
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I’m Donna, a longtime newspaper reporter, health writer and chronic illness thriver! Fed Up with Fatigue provides weekly news, research, treatments and more to help you live better with fibromyalgia and/or Lyme.
This sounds so promising and spot on! My mom developed fibro at about 55 yrs., I developed at about 35 yrs, and one of my daughters developed it at about 15 yrs old (she’s now 17). Interestingly we all struggle with herpes cold sores off and on as well (and my other daughter and two sons do not — nor do either of my siblings). I am really hoping this is offered in Canada. Would it be best to contact Dr. Pridgen, or will there be a general call-out when available in Canada? — Debbie
I’m not sure if there will be trial sites in Canada or not. They have not started patient recruitment for the trial yet but my plan is to publish an update when that begins. The best way to stay updated is to subscribe to my email list. There’s a form to do that on my home page and at the end of every article that I write.
I live in South Carolina and I would love to be a participate in the study. Where’s the study going to be and when.
I’m not sure if there will be trial sites in Canada or not. They have not started patient recruitment for the trial yet but my plan is to publish an update when that begins. The best way to stay updated is to subscribe to my email list. There’s a form to do that on my home page and at the end of every article that I write.
Would love to try this. I live in Colorado
I live in Philadelphia, PA and I am interested in participating in the trial. Please advise.
I would suggest contacting Dr. Pridgen’s practice in Alabama to see if they are recruiting yet.
I’m British and very interested in this trial. I have most definitely got fibro caused by herpes. I have ibs and b12 deficient I can pin pont exactly when I started being ill and have never been the same since. Any trials here in England. Please let me know.
The last time I talked w/ Dr. Pridgen, he wasn’t sure if all of the trial sites would be in the US or if the trial would go international. He said that decision depended on which company they picked as a partner. I would suggest reaching out to his clinic in Alabama to ask if there will be UK sites. I’m guessing it will be all USA but you never know.
I have been on Dr. Pridgin’s protocol for 5 years and have seen a tremendous amount of relief in pain and gi symptoms. I had almost continuous outbreaks of Herpes Simplex 1 including fever blisters, gi pain and diarrhea, and flu-like fibro pain which affected my entire body when I first went to see Dr. Pridgen. I live in the Texas Panhandle, so I had to travel once or twice a year to his practice in Alabama but finding help for my condition was definitely worth it. Dr. Pridgen suggested that I talk to my doctor at home to see if she would prescribe the medication for me. She was very open-minded and saw the improvement in my health, so she now prescribes my medication, and I no longer have to travel to Alabama. The virus still “breaks through” sometimes, but I do as Dr. Pridgen recommends and take more of the antiviral during these times and can get the virus back under control within a day or two. I still need extra rest because I also have allergies and mild asthma which stress my immune system, but now I can do almost any activity I want to. I am not sure that the Herpes Simplex virus is the cause of all fibro pain or that every patient will be be able to tolerate the medication (my sister can not tolerate Celebrex), but I have enjoyed a huge improvement in my quality of life and wish the same for others who are suffering. I have no connection to Dr. Pridgen other than being his patient, and I was not a patient in one of his studies, I just called his office and made an appointment with him personally. Perhaps this is another option for those who cannot get into the upcoming drug trial.
I’m so happy to read about your experience w/ Dr. Pridgen’s protocol. I’m excited to see how his trial goes! Even though I know it likely won’t help everyone w/ fibro, it is going to help a good number of people, and I am forever grateful to Dr. Pridgen for that! Keep me updated on how you’re doing!
Donna, Is there anywhere to find out dosages??
Unfortunately, Dr. Pridgen has never shared the dosages w/ me. I know Dr. Pridgen sees fibromyalgia patients at his Alabama office, and he used to sometimes partner w/ other physicians on patients from out of state. I’m not sure if he still does that or not. I would call his office to ask.
How can I get to contact Dr Pridgen’s office to discuss going on his protocol? My doctor is willing to prescribe these meds for me but I cannot find out what the dosages are….. I live in Jacksonville Florida. Thank you
This is the contact info for his practice. http://www.tuscaloosasurgery.com/contact-tuscaloosa-surgical.htm
Hi Tina,
I have searched far and wide for dosages of the celebrex and famvir as I have a doctor who is very willing to prescribe this. Could you please share the doses you are taking? Thank you, Heather
I am very interested I am diagnosed with Fibro, CFS, sleep apnea. Interested in the drug trial! Located in Ohio but I actually have ties in Alabama where this doctor is located that’s developing the medication.
I would definitely like to have more information about a clinical trial. My sister has fibromyalgia and I think I do also.
I was diagnosed, finally, with FM in 2014. But it wasn/t until 2016 that a new Dr. believed me. Have been fed the usual round of meds. I sometimes think I am a walking pharmacopeia. In Feb of 2019 I came down with shingles. Strange as it may seem, I knew by my nerve blasts that I had it even before the Dr. Only had a few blisters that didn’t weep due to getting on Valacyclovir. I have not been the same since the shingles outbreak. I am very interested in this trial. I live in Minnesota
I had Mono at 14 Chicken Pox at 19 diagnosed with Fibromyalgia at 26 also suffered a few injuries before and since the Fibro diagnosis that the pain I feel is blamed on the fibro. I have thought that there was a link somewhere but doctors in my area dont listen to patients theories.
I am willing to try this trial. I’m near Seattle, Washington. I have every symptom of ibs, fibro, herpes 1 and 2. Please enter my name in the mix.
You’ll want to keep a watch on ClinicalTrials.gov to find out when they start recruiting. I will try to post an update here on Fed Up with Fatigue as well.
The above info is very interesting And, a trial began at the Mass General Hospital in connection with EpigGenetic around late 2018. https://www.biospace.com/article/-cp8r-epicgenetics-and-massachusetts-general-hospital-to-launch-fibromyalgia-clinical-trial/ It has been approved by the FDA. I don’t think they are taking any more patients but perhaps the outcome will be promising. Does anyone know more about this new advancement in the treatment/cure of Fibromyalgia?
They haven’t started the BCG trial yet b/c they’re working on another genomic project first. This link includes an update – see #2: https://fedupwithfatigue.com/top-posts-2019/
I know this is USA based but is there any chance of any help for us in the UK? I have tried so many medication concoctions that I could rattle. We always seem to be behind over here. I have fibromyalgia, IBS, CFS etc and have the herpes complex.
Any help would be greatly appreciated 😊
If it’s approved in the US, I expect it will be available in the UK too.
I am interested in this trial. Please let me know where this will take place. this is the first i have heard of this trial. I am in California.
I would like to know more about this and if there are clinical trials for this
I am a patient of Dr. Pridgen as well as my mom and sisters. It works great. When my mom started she was having to use a wheelchair. Now 90%of the time she does not even need a Walker to get around. He is working on the stage 2b trial and it is supposed to start in early fall as stated in the article.
I tried it but it didn’t work for me! glad it work for you.
I had Mono at 14 Chicken Pox at 19 diagnosed with Fibromyalgia at 26 also suffered a few injuries before and since the Fibro diagnosis that the pain I feel is blamed on the fibro. I have thought that there was a link somewhere but doctors in my area dont listen to patients theories.
I have had fibro since a teenager, now 69. I also have the Herpes virus. I am also trying to get my voice heard that I believe measles has a lot to do with it. At a Support Group years ago, I asked all those there if they had had measles as a child. ALL put up their hands. One did not know. I had measles three times myself as a child. At the age of 5/6 my parents took me to a school for disabled children, I suppose thanks to my doctor, where they suggested (incredibly painful) stretching exercises for my poor little legs! My father had the herpes virus badly and mine lies dormant until a stressful event happens and BANG ON ONE WEEK LATER I get all the blisters. I have often thought there may be a connection
I have had HSV-1 about 48 years and was diagnosed with Fibromyalgia about 20 – 25 years ago. I take cymbalta and amitriptyline HCL amd also a anti-inflammatory but no anti viral. I do have fairly frequent outbreaks of the Herpes simplex and usually a few days before I have that outbreak I start to have more of the symptoms of fibro. More pain, more fatigue, more digestive issues, more sleep disturbances, etc. I would like to be considered for the next trials of this medication.
I was excited to read that Dr. Pridgen first tried IMC-1 in his Gasterenterolgy practice for his patients with IBS and fibromyalgia. I would definitely want to try this medication. My IBS always triggers a fibromyalgia flare.
Wow…makes total sense for a low-lying infection from a virus to be a possible cause. I’d love to know more about this and be a part of the trial — where can we get information to do that? Thanks for posting this!
You can look up Dr. Pridgen/fibromyalgia on the web and will pull up his articles. He is a great Dr. and has helped me a lot.
I’d give IMC-1 a try, I have tried the “approved” fibro medication’s and well lets just say they didn’t sit well with me.
I am very, desperately interested. And, I’ve had problems with shingles for years and years.I’ve noticed the correlation between taking the meds for it plus my 800mg ibuprofen. If there will be a link to the trial information, I would very much love to take part.
Thanks!!
You take ibuprofen daily and anti virals? Does that help?
If the rial comes to the UK then I’d definitely be interested in being involved. Suffered from fibromyalgia for 13 years and only seems to be getting worse.
Heck ya I’d try it! I think we all get to the point where we are willing to try anything! I’m currently trying the Guiafenesin protocol.
I tried that and it didn’t help 😞
This would be an incredible breakthrough for us and I am so excited to see it moving forward and that there will be centers around the US! It is about time that someone did something about fibromyalgia, CFS, etc. because they are not going away.
I would like to know more about the ICM-1 2B trial in the fall. This article was interesting. I have had cold sores in the past so I assume I have the Herpes 1 Virus. I was just put on Meloxicam (Mobic) for my arthritis and it has helped some. Tramadol alone doesn’t help with my pain. In fact, when I have flare-ups, I think it makes it worse. Please let me know if any trials will be in eastern Ohio area. Thank you!
Hi there!
This study’s results really sounds wonderful! It would be wonderful if a drug could be found, which is internationally available, and can lessen the symptoms of Fibromyalgia, so drastically!!!
Good luck with the upcoming trial! I look forward to see the results thereof and to be able to show this results to my Fibromyalgia treating dr, as it will be really amazing if something could be found to lessen the symptoms so drastically!
Thanks a lot for your commitment and passion to find a drug that could lessen our Fibromyalgia symptoms!
Greetings from a sunny South Africa
Adele Snyman
I believe all of this is related. I had shingles on my face between my eyes and side of nose. I was given an antibiotic at first because the FNP wasn’t really sure it was shingles. That seemed to lessen the progression of the shingles, but later on I began having pain in my joints, lots of IBS issues and lots of anxiety so Dr. diagnosed me with Fibromyalgia. I could not take Cymbalta but am on Tramadol and Gabapentin. It doesn’t really work that well and something is affecting my eyes now and I’ve just been put on Doxycylomine. My optometrist had suggested that when my eyes were being affected so I really believe all these symptoms could very well be tied to the HSV1. They just happened too c;pse/
Yes! I’d be very interested in a clinical trial. How can I be considered?
Hi Donna,
Firstly, thank you for your always informative newsletter. I love reading it and learning about new products, excercises, massages and clinical trials.
In regards to the IMC-1 clinic trial, I am definitely interested in those clinical trials. I would love to take 2 or 3 pills a day vs the 19 pills I take for my Fibromyalgia, Lupus, arthritis and anxiety. But I live in Canada so I suspect I will be waiting awhile for this drug to come my way.
Thanks again
Heather A.
I saw the initial study using Famiclovir and Celecoxib and my doctor agreed to let me try it. Unfortunately, I reacted to the Celecoxib on the second day and had to stop. My hands were swelling so much that I had to cut off my rings. I’m convinced that there is a connection between Fibromyalgia and the HSV-1. After I had my first outbreak of cold sores on my lips, including a fever that lasted days and generally feeling unwell, in 2001 I started developing symptoms of Fibromyalgia. These symptoms worsened with time and stress though I didn’t have a diagnosis until 2010 for Fibromyalgia. I also have frequent outbreaks of shingles, though not always a full-blown episode but just a couple of shingles here and there or pain on my skin with a fever for a day or two. I feel like my body is constantly fighting these viruses as if they are not dormant as they should be. I’m very interested in the results of this next study. Thanks for the information.
I got HSV when I was younger. Then I developed CFS. Now I have fibromyalgia so this theory makes sense to me. None of the top three drugs worked for me. I would love to be in this trial! How do I sign up?
VERY Interested in trying IMC-1
I would be very interested in trying this new medication. I always thought that there was some underlying virus or bacteria causing all of my symptoms. However I live in Canada and this study is not including Canada spat this point.
How can we get involved in this study?
I tried this combination about six years ago and it did nothing for me. My doctor consulted with Skip to find out the dosage for both drugs. He was nice enough to provide that information to my doctor. Unfortunately it wasn’t successful for me.
YES, THANK YOU! Where in Wisconsin is this available?
In regards to your report on the Herpes virus being the culprit behind Fibro, IBS, Cronic pain exhaustion and all the other symptoms. Yes, I believe he’s on the right trail. At age 23 I came down with Mono; unfortunately, even though I went to the doctors several times, it was not diagnosed until I became ill with Chickenpox (Side note*, I’m frequently reminded of the unbearable nerve pain I experienced at age 23 the night the chickenpox virus erupted. This pain radiated from my waist to behind my knees). The following 2 years I came down 3 different times with strep throat, which is known to go along with Mono. My health has never really recovered, I was diagnosed with chronic pain and fatigue, IBS, Fibromyalgia, myofascial etc.Also had 3 false positives for lyme disease. I really hope Dr.Pridgen’s study is given approval to be released for treatment. Do they need test subjects? If not I will be waiting for the medication to be released to pharmacy’s and Medical institutions to accept Dr.Pridgen’s findings and evidence.
Makes sense to me. My Me/cfs began in the year after I had a severe case of chicken pox (which is caused by HSV-1). I have never been the same since and that was 36 years ago. More conditions have flared up since including fibromyalgia & mcs. I wish they would include Canada in the trial. I’d be willing to try it.
According to Wikipedia, chickenpox is caused by human alphaherpesvirus 3 (HHV-3) aka the varicella-zoster virus (VZV), not HSV-1.
I would give ANYTHING to find a drug that will help. I became addicted to pain meds (thanks pain management) please tell me how to go about signing up for the trial