Virios Therapeutics, Inc. Reaches Alignment with FDA on Requirements for Advancing Development Candidate IMC-2 as Treatment for Long-COVID

Rhea-AI Summary

Virios Therapeutics, Inc. (Nasdaq: VIRI) has received feedback from the FDA on advancing IMC-2 as a treatment for Long-COVID (LC) illness. The FDA agreed to use fatigue as the primary endpoint and orthostatic intolerance as a key secondary endpoint to assess the effectiveness of IMC-2. Virios is exploring options to advance the IMC-2 LC Phase 2 research program, with the potential to be one of the first approved treatments specifically for LC.

Insights

Medical Research Analyst

The feedback from the FDA regarding Virios Therapeutics' IMC-2 program signifies a critical step in the drug development process for treating post-acute sequelae of SARS-CoV-2 infection (PASC), or Long-COVID. The decision to allow fatigue as the primary endpoint and orthostatic intolerance as a secondary endpoint in Phase 2 trials is pivotal. These symptoms are among the most incapacitating for patients and their selection as endpoints ensures that the study's outcomes will directly address patient needs. The recommendation to assess a range of IMC-2 doses, specifically higher doses of valacyclovir, indicates a thorough approach to determining the optimal therapeutic window that balances efficacy with safety.

Given the prevalence of Long-COVID, with an estimated 7% of US adults having experienced it, the potential market for an effective treatment is substantial. The morbidity burden associated with Long-COVID, as noted in the Australian study, underscores the urgency and potential impact of such a treatment. If successful, IMC-2 could not only alleviate patient suffering but also reduce the economic burden of Long-COVID through improved productivity and reduced healthcare costs.

Financial Analyst

Virios Therapeutics' advancement in the FDA regulatory process could have significant financial implications. The potential approval of IMC-2 as a treatment for Long-COVID could open a lucrative market for the company, considering the high prevalence of the condition. The stock market often reacts positively to such advancements, as they bring a company closer to potential revenue from a new product. However, investors should consider the costs associated with advancing the Phase 2 research program and the inherent risks of clinical trials.

Furthermore, it is essential to analyze Virios Therapeutics' financial position and funding strategy to sustain the research program. The company's ability to navigate the costly and time-consuming process of drug development will be critical in realizing the potential market opportunity. Additionally, the competitive landscape should be evaluated, as other companies may also be pursuing treatments for Long-COVID, which could impact Virios' market share and pricing power if IMC-2 is approved.

Market Research Analyst

The demand for Long-COVID treatments is driven by both the high prevalence of the condition and the lack of approved therapies targeting this patient population specifically. Virios Therapeutics' focus on this unmet medical need positions the company to capitalize on first-mover advantage if IMC-2 is approved. Market dynamics such as patient and physician awareness, accessibility and reimbursement will play crucial roles in the adoption of IMC-2.

Understanding the patient journey and the healthcare system's readiness to integrate new treatments for Long-COVID will be essential for forecasting the potential market penetration of IMC-2. The company's marketing strategy, partnerships and distribution channels will also be influential factors in the commercial success of the treatment. It is vital to monitor ongoing and upcoming clinical trials by competitors, as these could affect market expectations and positioning.

ATLANTA, Jan. 02, 2024 (GLOBE NEWSWIRE) -- Virios Therapeutics, Inc. (Nasdaq: VIRI) (the “Company”), a development-stage biotechnology company focused on developing novel antiviral therapies to treat debilitating chronic diseases, including fibromyalgia (“FM”) and Long-COVID (“LC”), today announced receipt of the Food and Drug Administration’s (“FDA”) feedback on requirements for advancing IMC-2 (combination of valacyclovir + celecoxib) as a treatment for the fatigue, orthostatic intolerance and other symptoms associated with LC illness, also known as post-acute sequelae of SARS-CoV-2 infection (“PASC”).

Key Highlights Associated with FDA Feedback

• The FDA agreed that for the planned Phase 2 proof-of-concept study, Virios can use fatigue as the primary endpoint and orthostatic intolerance as a key secondary endpoint to assess the effectiveness of IMC-2 in treating PASC.
• The FDA recommended assessment of a range of IMC-2 doses, including valacyclovir doses above presently approved dosage strengths, to ensure effective inhibition of reactivated herpesvirus.
• Following the receipt of the FDA’s feedback, Virios is currently exploring options to advance the IMC-2 LC Phase 2 research program.
• IMC-2 has the potential to be one of the first approved treatments specifically for LC.

“The National Service for Health Statistics estimates approximately 7% of US adults have had Long-COVID and strikingly, that 3.4% of adults currently have Long-COVID,” said Greg Duncan, Chairman and CEO of Virios Therapeutics. “An Australian study found that 74% of the morbidity associated with SARS-COV-2 infection is associated with Long-COVID illness, further highlighting the need for new Long-COVID treatments,” Duncan added.

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 dose 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 Annual Report on Form 10-K for the year ended December 31, 2022, 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.

Contact:
IR@Virios.com 

FAQ

What is the company name and ticker symbol for Virios Therapeutics?

The company name is Virios Therapeutics, Inc. and the ticker symbol is VIRI.

What is IMC-2 and what is it being developed for?

IMC-2 is a combination of valacyclovir + celecoxib being developed as a treatment for Long-COVID (LC) illness.

What feedback did Virios Therapeutics receive from the FDA?

The FDA agreed to use fatigue as the primary endpoint and orthostatic intolerance as a key secondary endpoint to assess the effectiveness of IMC-2 in treating PASC. The FDA also recommended assessment of a range of IMC-2 doses, including valacyclovir doses above presently approved dosage strengths, to ensure effective inhibition of reactivated herpesvirus.

What percentage of US adults have Long-COVID according to the National Service for Health Statistics?

The National Service for Health Statistics estimates that approximately 7% of US adults have had Long-COVID and 3.4% of adults currently have Long-COVID.

What is the potential impact of IMC-2 as a treatment for Long-COVID?

IMC-2 has the potential to be one of the first approved treatments specifically for Long-COVID, addressing the need for new treatments for this debilitating illness.