VIRI Virios Therapeutics Inc

Virios Therapeutics, Inc. (Nasdaq: VIRI) (the “Company”), a development-stage biotechnology company focused on advancing novel antiviral therapies to treat debilitating chronic diseases, including fibromyalgia (“FM”) and Long-COVID (“LC”), today announced that the Bateman Horne Center (“BHC”) has completed enrollment in its investigator-initiated, proof of concept LC study. Top line data from this study are projected to be released in October 2024.

The BHC study is a randomized, double-blind, placebo-controlled evaluation of the combination of valacyclovir and celecoxib (IMC-2) as a treatment for fatigue and other symptoms associated with LC illness. This study follows on from a positive prior investigator-initiated proof of concept study demonstrating that the valacyclovir/celecoxib combination improved fatigue, pain, orthostatic symptoms, anxiety and overall patient LC health when compared with an untreated control group of patients matched by age, gender, COVID vaccination rates and duration of illness.

Greg Duncan, Chairman and CEO of Virios, stated, “We believe that activated herpes virus may serve as a potential catalyst for triggering or maintaining diseases like LC and FM. Our novel antiviral combination could be a ‘game changer’ for millions of patients suffering from LC, who are desperate for relief from their ongoing health issues, particularly in the context of the recent negative study assessing Paxlovid as a treatment for LC.”

The 2024 National Center for Health Statistics Household Pulse Survey estimates that 17.6% of the U.S. population, representing nearly 45 million potential adult patients, have experienced LC since the pandemic started in November of 2019. There are no treatments approved by the FDA to treat the symptoms associated with LC, further highlighting the need for new treatments.

A multitude of studies suggest that while LC is a consequence of SARS-CoV-2 virus infection, the development of LC seems related to immune system dysfunction and complement activation. It has been postulated that an exhausted immune response resulting from the initial COVID-19 infection enables previously dormant herpesviruses to reactivate due to the compromised immune response. Reactivated herpes viruses such as Epstein-Barr virus (EBV) may be associated with fatigue and cognitive dysfunction. Fatigue and cognitive dysfunction are predominant LC symptoms.

About Virios Therapeutics

Virios Therapeutics (Nasdaq: VIRI) is a development-stage biotechnology company focused on advancing novel antiviral therapies to treat diseases associated with a viral triggered abnormal immune response such as fibromyalgia (“FM”) and Long-COVID (“LC”). Overactive immune response related to activation of tissue resident herpesvirus has been postulated to be a potential root cause of chronic illnesses such as FM, irritable bowel syndrome, LC, chronic fatigue syndrome and functional somatic syndromes, all of which are characterized by a waxing and waning manifestation of disease, often triggered by events which compromise the immune system. The Company’s lead development candidates are novel, proprietary, fixed dose combinations of an antiviral compound and celecoxib designed to synergistically suppress herpesvirus replication, with the end goal of reducing virally promoted disease symptoms. IMC-1 (fixed dosage combination of famciclovir and celecoxib) has been granted fast track designation by the FDA.

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 Amended Annual Report on Form 10-K/A for the year ended December 31, 2023, 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.

Contact

IR@Virios.com