Virios Therapeutics Announces Publication of International Patent for IMC-2 Covering Antiviral Treatment of Long-COVID
Virios Therapeutics, Inc. announces a new patent that extends global coverage for their antiviral pipeline, focusing on treating Long-COVID symptoms with a combination of valacyclovir and celecoxib. The company's study shows promising results in reducing fatigue, pain, and anxiety associated with Long-COVID, with further trials ongoing.
The publication of Virios Therapeutics' global patent application by the WIPO marks a significant strategic move for the company, potentially bolstering its intellectual property portfolio and enhancing its competitive edge in the antiviral drug market. The scope of this patent, which encompasses the use of a proprietary combination of valacyclovir and celecoxib for treating Alzheimer's and COVID-19, suggests a broad therapeutic application that could have substantial implications for market expansion and revenue diversification.
From a medical research perspective, the combination of valacyclovir, an antiviral, with celecoxib, an anti-inflammatory, is an innovative approach to tackling diseases with viral and inflammatory components. The exploratory study showing positive results in Long-COVID symptoms is promising, given the absence of FDA-approved treatments for this condition. The ongoing double-blind study will be pivotal in determining the efficacy and safety of the treatment, which, if positive, could lead to increased investor confidence and potentially accelerate the FDA approval process.
Virios Therapeutics' expansion into the Long-COVID treatment market through their patent application is timely, considering the significant portion of the population affected by this condition. With an estimated 45 million potential adult patients in the US alone, the market opportunity for effective Long-COVID treatments is substantial. The absence of FDA-approved treatments for Long-COVID symptoms presents a window of opportunity for Virios to establish market leadership if their combination therapy proves successful.
However, the economic impact of introducing a new treatment extends beyond the potential market size. It includes considerations such as pricing strategy, insurance coverage and healthcare savings by reducing the burden of chronic symptoms on patients and the healthcare system. Moreover, the success of such a treatment could lead to positive externalities, including increased workforce productivity and reduced long-term healthcare costs associated with managing chronic Long-COVID symptoms.
The announcement of a global patent application by Virios Therapeutics is a strategic maneuver aimed at protecting their proprietary combination therapy. In the pharmaceutical industry, patents are a form of competitive advantage that can lead to monopolistic market positions for a certain period. The fact that this patent covers a treatment for two high-profile diseases - Alzheimer's and COVID-19 - may attract significant interest from investors, as the addressable market for both indications is vast and growing.
Investors should monitor the progress of the ongoing placebo-controlled study closely, as its results will likely impact Virios' stock performance. A successful trial could lead to a surge in stock value, while unfavorable results could have the opposite effect. It's also important to consider the company's ability to navigate the regulatory landscape, scale production and effectively market the therapy post-approval, which are critical factors in realizing the potential value of the patent.
03/26/2024 - 09:15 AM
- New patent would extend coverage and expand potential value of Virios’ antiviral pipeline globally –
- Active Long-COVID characterized by immune dysfunction leading to recurrent herpesviruses reactivation -
- Published data indicates increased Epstein-Barr herpes virus in Long-COVID patients, highlighting potential for antiviral therapy to treat fatigue and other Long-COVID symptoms –
ATLANTA, March 26, 2024 (GLOBE NEWSWIRE) -- Virios Therapeutics, Inc. fibromyalgia Long-COVID (“LC”), today announced that the World Intellectual Property Organization (WIPO) has published Virios’ global patent application titled “Valacyclovir and Celecoxib for the Treatment of Alzheimer’s and COVID-19”, which covers the use of IMC-2, a proprietary combination of valacyclovir and celecoxib. This milestone enables Virios to streamline the process for obtaining patent protection globally, representing a precursor to the national phase of patent examination by targeted countries across the globe.
An open-label, exploratory LC study sponsored by Virios demonstrated that treatment with the combination of valacyclovir and celecoxib resulted in clinical and statistically significant reductions in LC associated fatigue, orthostatic intolerance, pain and anxiety. Combination treatment with valacyclovir and celecoxib is presently being assessed in a double blind, placebo-controlled study under the direction of Dr. Lucinda Bateman, MD, supported by an unrestricted, investigational grant provided by the Company to the Bateman Horne Center. Results from this important trial are expected this summer.
The 2024 National Center for Health Statistics Household Pulse Survey estimates that 17.6% of the US population have experienced LC, representing upwards of 45 million potential adult patients, since the pandemic started in November of 2019. Previous estimates suggest that up to 10 million children in the US have also experienced LC. 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 to COVID-19 enables reactivation of previously dormant herpesviruses. Reactivated herpesviruses 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. Our 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.
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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, 2023, filed with the Securities and Exchange Commission. In particular, there can be no assurance that any development partnership or other transaction involving Virios Therapeutics will be completed on favorable terms, or at all. 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.
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What is the focus of Virios Therapeutics' new patent application?
The focus is on extending global coverage for their antiviral pipeline, specifically targeting the treatment of Long-COVID symptoms.
What combination of drugs is being used by Virios Therapeutics to treat Long-COVID?
Valacyclovir and celecoxib are being used in combination to treat Long-COVID symptoms.
What were the results of the open-label, exploratory Long-COVID study sponsored by Virios?
The study showed significant reductions in fatigue, pain, orthostatic intolerance, and anxiety associated with Long-COVID.
Who is leading the double-blind, placebo-controlled study on valacyclovir and celecoxib for Long-COVID?
Dr. Lucinda Bateman, MD, is leading the study supported by an investigational grant from Virios Therapeutics.
How many potential adult patients in the US have experienced Long-COVID according to the 2024 National Center for Health Statistics Household Pulse Survey?
Upwards of 45 million potential adult patients have experienced Long-COVID since the pandemic started in November 2019.
What symptoms of Long-COVID are associated with reactivated herpesviruses like Epstein-Barr virus?
Fatigue and cognitive dysfunction are predominant symptoms associated with reactivated herpesviruses in Long-COVID patients.
