Virios Therapeutics (Nasdaq: VIRI) Advancing Potential Paradigm Shift in Fibromyalgia Treatment

Armed with near-term catalyst, VIRI is poised for next growth stage

New York, NY - (NewMediaWire) - July 26, 2022 - PCG Digital -- Development-stage biotechnology company Virios Therapeutics(NASDAQ: VIRI) is working to advance a new therapeutic approach, one that is focused on addressing a potential root cause of Fibromyalgia (FM), a catalyst the company believes is related to activation of previously dormant herpes virus infection.  VIRI is anticipating top line results this September from its ongoing FM Phase 2b trial, featuring its lead combination antiviral development candidate, oral IMC-1.  An earlier FM Phase 2a study demonstrated IMC-1’s effectiveness and tolerability better than placebo, which could serve as a distinguishing differentiating feature of IMC-1 versus other approved FM treatments.

FM is a medical condition experienced by approximately 2% of the population and is characterized by severe, widespread pain and fatigue, as well as symptoms pertaining to impaired mental health, such as anxiety and depression. Unfortunately, many patients suffering from FM are dissatisfied with available FM treatments.  This dissatisfaction relates to both the limited FDA approved treatment options, all of which are focused solely on symptom management, and the burdensome side-effects often resulting in discontinuation of these approved therapies. 

We sat down with Virios CEO Greg Duncan to find out more about the company’s research programs, target diseases and upcoming milestones.

Q. Can you explain your catchphrase of “a new treatment paradigm targeting viral mediated chronic diseases?” 

A. Virios was founded by Dr. William Pridgen on the premise that many common viruses, most notably herpes viruses, can become activated and serve as the catalyst for the symptomatic “flare-ups” associated with many chronic diseases, including FM and irritable bowel syndrome (“IBS”). The Company is focused on developing dual-mechanism antiviral therapies, specifically designed to convert activated herpes viruses back to a dormant state, with the goal to deliver significant clinical benefits for patients diagnosed with FM, IBS and fatigue related disorder patients, including long-Covid.

Q. Tell us about your lead candidate IMC-1? 

A. When herpes viruses become activated, they replicate and can trigger an “overheated” immune response. Our lead development candidate, oral IMC-1, is a dual-mechanism antiviral therapy that has been specifically designed to inhibit viral replication and convert activated herpes viruses back into dormancy. Specifically, IMC-1 combines two existing therapies, famciclovir and celecoxib, whose synergistic mechanisms inhibit activated herpes viruses from replicating and transitioning herpes back into a dormant state.  By doing so, we believe IMC-1 exerts its clinical benefits, including reducing FM related pain and fatigue, as well as improving FM patient daily functioning.  IMC-1 was tolerated better than placebo in a previous trials. These results are especially encouraging given the most recent FDA approved medicine was in 2009.

Q. IMC-1 was recently granted the first-ever fast track statusfor a fibromyalgia treatment by the FDA.  Can you give us an update on the current research program? 

A. IMC-1 is currently being tested in a multi-center, randomized, double-blind, placebo-controlled Phase 2b trial (“FORTRESS”) of over 400 female FM patients. The design of this trial is broadly consistent with Phase 3 requirements, and our hope is that if successful, the FORTRESS trial might serve as one of the two required Phase 3 trials necessary for approval.   

Recent clinical trial data presented at the European Congress of Rheumatology EULAR Congress and the IASP World Congress on Pain last year, shows that treating FM patients with IMC-1 significantly reduced FM symptoms, including not only pain and fatigue, but also stiffness, depression, anxiety, and sleep disturbance.Importantly,patients treated with IMC-1 also exhibited a lower trialdrop-out rate due to adverse events when compared to placebo-treated patients.

In parallel with the FORTRESS trial, Virios is executing two chronic toxicology studies of IMC-1 in two animal species. The results of these studies are required by regulators before Virios will be allowed to dose patients for one year or more, which is the plan for the Phase 3 program, presuming success in our current Phase 2b trial. 

Q. The global treatment market for fibromyalgia was estimated at $1.9 billion in 2019. Where does IMC-1 fit into the broader spectrum of things?

A. The fibromyalgia marketplace is large, but unfortunately very dissatisfied, largely due to poor tolerability of the existing three approved medications. In our view, this large, dissatisfied market represents a very significant commercial opportunity for a company who successfully develops a new safe and effective FM treatment.

Epidemiologic surveys suggest approximately 2% of the population across the globe meet the diagnostic criteria for FM. This is a debilitating condition that patients have to struggle with for most of their lives. Of the 10 million US patients that the National Fibromyalgia and Chronic Pain Association estimates who suffer from FM, we project about a third, or 3.6 million patients are actually diagnosed, but only about 2 million are treated.  

Based on the Virios team’s experience, many of those 3.6 million patients who are diagnosed have been on some form of therapy, either one of the approved therapies or other therapies, in an attempt to find better relief from their FM symptoms. We believe patients are looking for something that's either more effective and/or better tolerated than the current options. Our novel antiviral combination could be a game changer for millions of patients suffering from FM, especially given that our market research indicates only 15% of surveyed physicians treating FM patients report satisfaction with existing treatment options. If IMC-1 can deliver benefits clinically and continues to be tolerated as well as it demonstrated in our Phase 2a research, we believe IMC-1 could potentially become a first-line therapy for FM patients across the globe.

Q. What should investors look out for in the near term?

A. The second half of 2022 is going to be an exciting time for Virios as we continue to deliver on our strategic and operational plans. Our research team completed enrollment in the Phase 2b FORTRESS study this past April. 

We project to commence dosing in our exploratory Phase 1 long Covid trial in August with our second development combination, valacyclovir and celecoxib.  This trial is being conducted via an unrestricted investigational grant to the Bateman Horne Center (BHC). BHC will test the hypothesis that dormant herpes viruses are being reactivated in long-Covid patients.  The co-infection of SARS and herpes viruses, such the Epstein Barr virus, may hold the key to improving the long-term fatigue and impaired concentration (aka “brain fog”) symptoms experienced by long-Covid patients. The study subjects will be treated for 14 weeks with a number of parameters being examined, including fatigue and brain fog. With an expected start in the third quarter of 2022, we anticipate topline data in the first half of 2023.

Most importantly, the countdown begins to the release of topline Phase 2b results, which we believe will occur in September 2022. The results of the chronic toxicology studies should be available at approximately the same time, thus Virios should be in position to approach the FDA  in Q4 of this year to discuss advancing IMC-1 into a Phase 3 program in fibromyalgia, pending positive results from the FORTRESS study.

Q. You have an impressive track record. What lessons did you learn while developing and commercializing products for well-established pharmaceutical companies, such as Pfizer and UCB? 

A. We recognize that improving patient care is at the center of everything we do.  We target diseases where patients are dissatisfied, and the research pipeline is lacking, both the number and quality of novel new approaches. FM patients are desperate for new treatment options and there is limited significant innovation ongoing in the FM pipeline, hence FM represents a perfect opportunity for advancing novel new therapeutic therapeutics like IMC-1.

Furthermore, members of the VIRI executive team and board of directors have been involved in the development and commercialization of many categories of leading medicines, including two of the three approved fibromyalgia medications, both Lyrica and Savella, so we have deep experience in the FM disease area. In fact, our chief medical officer, Dr. Mike Gendreau, previously served as a consultant to the FDA to help them define the process that's used to approve new therapies.  

Lastly, this experience has enabled the team to develop productive research relationships with many of the top US FM research sites.  Based on interest in IMC-1 gleaned from the strong data generated in our Phase 2a FM trial, and the team’s unsurpassed long-term relationships with key FM research investigators, we were able to fully enroll over 400 patients in our Phase 2b FORTRESS study of IMC-1 in the middle of the Covid pandemic.   

In short, VIRI is advancing a novel new approach to treating a dissatisfied FM patient community with research sites we know very well, based on our prior experiences.  

Q.Can you talk about your cash on hand and how long you expect it will last?

A. As of March 31, 2022, our cash totaled $11.4 million, and we believe we have sufficient resources to fund planned operations through the end of 2022. The Fortress program, and the long-covid programs are fully funded, so we do not need to raise capital until we actually harvest the Phase 2b FM data in September.  We have no debt and management represents 20% of VIRI shares on a fully diluted basis, this is very well aligned with shareholders.   

Forward-Looking Statements

Statements in this press release contain “forward-looking statements,” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “suggest,” “target,” “aim,” “should,” "will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Virios Therapeutics’ current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including risks related to the success, cost and timing of Virios Therapeutics’ preclinical studies and clinical trials; its ability to obtain regulatory approval for IMC-1, IMC-2 and any future product candidates; the company’s need for additional funding; and Virios Therapeutics’ ability to develop and, if approved, commercialize its product candidates. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in the Annual Report on Form 10-K for the year ended December 31, 2021, filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Virios Therapeutics, Inc. (VIRI) undertakes no duty to update such information except as required under applicable law.

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