Virios Therapeutics Announces Exploratory Long-COVID Trial Top-Line Data, Featuring Combination of Valacyclovir and Celecoxib, Projected in June 2023

ATLANTA, Feb. 13, 2023 (GLOBE NEWSWIRE) — Virios Therapeutics, Inc. (Nasdaq: VIRI), a development-stage biotechnology company focused on advancing novel, combination antiviral therapies to treat debilitating chronic diseases including fibromyalgia (“FM”), announced today that it expects top-line results from its Phase 2 Post-Acute Sequelae of COVID-19 (also known as PASC or Long-COVID) exploratory clinical trial to be available in June 2023. This study will assess the potential of the antiviral combination of valacyclovir and celecoxib to provide symptomatic improvements in patients suffering from Long-COVID when added to standard of care therapy. Outcomes being assessed in this study include fatigue, sleep, attention, pain, autonomic function, memory and anxiety.

• Prevalence estimates suggest over 600 million people worldwide have been infected with COVID-19 (SARS-CoV-2)
• As many as 30% of COVID-19 patients will experience some degree of PASC symptoms
• SARS-CoV-2 infection appears to be a potent trigger for reactivation of latent herpes virus infection
• Neurocognitive impairment and fatigue have been linked to reactivation of the Epstein-Barr form of herpes virus

This study is supported via an unrestricted investigational grant to the Bateman Horne Center, a non-profit, interdisciplinary Center of Excellence advancing the diagnosis and treatment of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), fibromyalgia, post-viral syndromes including Long-COVID, and related comorbidities.

About Virios Therapeutics

Virios Therapeutics (Nasdaq: VIRI) is a development-stage biotechnology company focused on advancing novel antiviral therapies to treat debilitating chronic diseases, such as fibromyalgia. Immune responses related to the activation of tissue resident herpes have been postulated as a potential root cause triggering and/or sustaining chronic illnesses such as FM, irritable bowel disease, chronic fatigue syndrome and other functional somatic syndromes, all of which are characterized by waxing and waning symptoms with no obvious etiology. Our lead development candidate, IMC-1, is a novel, proprietary, fixed dose combination of famciclovir and celecoxib designed to synergistically suppress herpes virus replication, with the end goal of reducing virally promoted disease symptoms. IMC-1 has been granted fast track designation by the FDA.

The Company is pursuing a second development candidate, IMC-2 (valacyclovir and celecoxib), as a potential treatment for managing the fatigue, sleep, attention, pain, autonomic function and anxiety associated with Long-COVID.

For more information, please visit www.virios.com.

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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 completion, timing and results of current and future clinical studies relating to Virios Therapeutics’ 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. undertakes no duty to update such information except as required under applicable law.

Contacts:
IR@Virios.com

Source: Virios Therapeutics, Inc. (VIRI)