Virios’ Promising Fibromyalgia Treatment Candidate Expects September 2022 Phase 2b Results

With the aim of improving the standard of care for the 10 million Americans living with fibromyalgia (“FM”), Virios Therapeutics (Nasdaq: VIRI) anticipates Phase 2b results for its lead treatment candidate, oral IMC-1, in September.

FM is a debilitating, chronic disorder characterized by widespread pain and severe fatigue, increased levels of depression, anxiety and trouble sleeping. It poses both a significant economic burden and high personal cost for sufferers. Many patients worldwide are seeking safe and effective new therapies.

IMC-1 is a novel, fixed dose, combination antiviral therapy which has demonstrated improvement in pain, fatigue, anxiety, depression and sleep disturbances in a completed phase 2a FM trial.  IMC-1 combines two existing medicines, famciclovir and celecoxib, that have been specifically combined to inhibit virus activation.  The global FM treatment market was estimated at $1.9 billion in 2019 and many patients report severe dissatisfaction with the three FDA approved FM treatments, which manage symptoms rather than treating a potential root cause of the disease.

On the fast track

 Given the significant “unmet medical need” in treating FM, as well as the novelty of VIRI’s approach, IMC-1 was granted the first-ever FDA “fast track” review status for a FM development candidate.  IMC-1 is being tested in a multi-center, randomized, double-blind, placebo-controlled Phase 2b trial of more than 400 patients that is designed in broad concordance with Phase 3 study requirements.

Virios continues to add value

Virios is also pursuing a second development candidate, a combination of valacyclovir and celecoxib, as a potential treatment for managing fatigue, poor concentration, sleep disruption, pain, anxiety and other symptoms associated with long Covid.  This exploratory program is supported through an unrestricted investigational grant provided to the Salt Lake City-based Bateman Horne Center (“BHC”). BHC has commenced dosing of patients with valacyclovir and celecoxib and projects to fully enroll the program by the end of 2022, with results currently projected in the first half of 2023.

As of March 31, 2022, Virios Therapeutics’ cash totaled $11.4 million. The Company believes it will have sufficient resources to fund its planned operations through the end of 2022. In addition, members of VIRI’s  management team and board recently purchased shares of the company’s common stock on the open market, representing a significant alignment of interests with VIRI shareholders.

If results from the latest IMC-1 trial match those of the positive Phase 2a study, Virios believes that IMC-1 has the potential to be a novel new treatment for millions of patients across the globe suffering from FM. This could be a significant development for Virios, patients and investors alike.

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.