PCG Digital -- Life may change for the better for the 10 million Americans suffering from fibromyalgia. The development-stage biotech Virios Therapeutics, Inc. (NASDAQ: VIRI) is anticipating the reporting of phase 2b treatment results for its lead fibromyalgia treatment candidate this September and continues to add value through its research and development of compelling clinical assets for multiple categories of viruses.

Virios Therapeutics, Inc.

Humans and viral pathogens have co-existed for millennia. Some human viruses are gone as quickly as they came, while others - such as the herpes virus - are able to co-exist with a human's immune system, leaving genetic material permanently in the host's cells.

Nearly four billion people around the world are infected with herpes viruses. Most of us don't even know if we are infected and the virus may remain dormant in the body for months or years before reactivating in response to stress.

Dr. William Pridgen, the founder of Virios Therapeutics, Inc. has observed the effects of virus reactivation firsthand. In 2002, he noted recurring functional gastrointestinal disorder symptoms ("FGIDs") in his surgical patients that waxed and waned, worsening in times of stress. He observed that his treatment protocol for these patients - a combination of antiviral drugs - not only improved his patient's FGIDs, but also alleviated symptoms including pain, fatigue, depression and fibromyalgia (FM).

We spoke with Dr. Pridgen to learn more about the virus hypothesis and why he thinks Virios Therapeutics' lead candidate could potentially be life-changing for the 10 million Americans living with FM.

Q: Can you tell us about FM and how IMC-1, Virios Therapeutics' lead product candidate, could potentially be an effective treatment?

FM is a chronic pain disorder characterized by severe fatigue, gastrointestinal and sleep disturbances and increased levels of depression and anxiety. It can be difficult to diagnose - on average, patients wait five years for a diagnosis, due to the lack of widely-accepted medical testing - and the disorder can be even harder to treat. There are currently three FDA approved drugs available to FM patients, each of which treat the symptoms of FM, rather than targeting a potential underlying cause of the disease. All three approved medications work to control pain, but often induce side-effects which can limit their utility when used chronically, as is required to manage FM. As a result, patients are largely dissatisfied with available treatments.

In a recent phase 2a double-blind randomized controlled trial, FM patients who took IMC-1 reported statistically significant improvements in pain, fatigue, anxiety and depression compared with patients treated with placebo. Notably, IMC-1 was better tolerated than placebo in this proof-of-concept trial. A follow-on phase 2b trial of IMC-1, called FORTRESS (Fibromyalgia Outcome Research Trial Evaluating Synergistic Suppression of HSV-1), is fully recruited, with results expected to be reported in September 2022.

Q: How does IMC-1 work?

It is my belief that viral outbreaks of herpes resident in the central nervous system, where the brain amplifies the aberrant pain processes that the research community believes is causing FM. Our lead development candidate, oral IMC-1, offers the exciting potential to treat a potential root cause of fibromyalgia - not just management of select symptoms - but by suppressing viral activity and improving FM patients symptoms and functioning.

IMC-1 is a fixed-dose combination of two medications, famciclovir and celecoxib, that work together to inhibit replication of activated herpes viruses and convert activated herpes back into a dormant state. Famciclovir inhibits viral DNA polymerase, a key enzyme that the virus uses to make DNA and replicate. Meanwhile, celecoxib inhibits a different enzyme, cyclooxygenase-2, which is upregulated during herpes virus replication. By targeting two enzymes important for viral replication, this combination treatment has to-date proven to effectively treat FM, and because of the novelty of the approach, has garnered the first-ever FDA "fast track" review designation.

Q: Based on your real-world experience, can you tell us more about how IMC-1 has the potential to change lives?

Living with FM can be debilitating and isolating. Affected patients carry a three times greater risk for committing suicide. Patients fight for a diagnosis for years, and when they get their diagnosis, they are often unsatisfied with their prescribed treatment. In my practice, and in research carried out with my colleague, virologist Dr. Carol Duffy, we have seen marked increase in the presence of actively replicating herpes simplex virus type 1 in gastric mucosal tissue from patient groups with functional gastrointestinal disorders and with FM, as compared to control patients.

In my experience, IMC-1 treats the potential root cause of several somatic syndrome disorders, and we've demonstrated that the two antivirals together do something that individually the components failed to achieve, notably, reducing the symptoms associated with a FM diagnosis. By targeting the potential viral trigger of FM, we hope to not only treat acute FM symptom "flare-ups", but also delay future FM "flare-ups" by keeping the herpes virus in a dormant state through chronic administration of IMC-1.

Q: Virios has been working through rigorous clinical trials to establish the safety and efficacy of IMC-1. What can we expect to see next from the company?

A: Virios announced in April that it had completed enrollment in its 425 patient Phase 2b FORTRESS clinical trial, which is a testament to the interest and motivation that clinicians, investigators and patients have shown about being involved in the study. The study will build on the statistically significant results from Virios' previous clinical study, which evaluated 143 FM patients, and demonstrated that IMC-1 improved FM patient pain, fatigue, anxiety and depression, as well as improved their overall functioning. Importantly in the context of current patient dissatisfaction with FDA approved medications, IMC-1 was statistically better tolerated than placebo. If IMC-1 proves to be as effective and well tolerated in the ongoing Phase 2b trial as it was in the completed Phase 2a trial, we think we have a potential game changing therapy for FM patients worldwide.

Virios expects to report top line results for its phase 2b FORTRESS clinical trial in September 2022. At the same time, the company is completing chronic toxicology studies in preparation for future FM Phase 3 program discussions with FDA. It is an exciting time for Virios and its shareholders but more than that, it has the potential to completely change the lives of FM patients.

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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