Virios Therapeutics Announces Plans to Advance Development of IMC-2 as Treatment for Symptoms Associated with Long-COVID
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Insights
The announcement from Virios Therapeutics regarding the advancement of IMC-2 into a Phase 2 clinical program for the treatment of Long-COVID (LC) symptoms is a significant development within the biotechnology sector. The absence of FDA-approved treatments for LC presents a considerable market opportunity for new therapeutic agents. The combination therapy of valacyclovir and celecoxib, known as IMC-2, targets the fatigue and orthostatic intolerance often associated with post-acute sequelae of SARS-CoV-2 infection (PASC).
Valacyclovir is an antiviral medication that is typically used to treat herpes virus infections, while celecoxib is a nonsteroidal anti-inflammatory drug (NSAID) that addresses inflammation and pain. The rationale behind the combination therapy hinges on the hypothesis that viral reactivation and inflammatory responses contribute to LC symptoms. The synergy between an antiviral and an anti-inflammatory could potentially address the multifactorial nature of LC.
The expected data from the ongoing placebo-controlled study in mid-2024 will provide critical insights into the efficacy and safety profile of IMC-2. If the data are positive, it could lead to a significant revaluation of Virios Therapeutics' market potential. Additionally, the FDA's agreement on using fatigue reduction as a primary endpoint is noteworthy since it provides a clear regulatory pathway for the clinical development of IMC-2.
From a market perspective, the progression of IMC-2 into Phase 2 trials is a pivotal moment for Virios Therapeutics. The company's focus on a novel treatment for LC symptoms targets a gap in the current medical landscape. Given the prevalence of LC and the ongoing impact of the COVID-19 pandemic, the demand for effective treatments is substantial. The potential market size for LC treatments could be vast, considering the millions of individuals worldwide suffering from PASC.
The strategic decision to explore the extension of IMC-2's indication to other fatigue-related illnesses, such as Chronic Fatigue Syndrome, indicates a broader market strategy that could further increase the drug's commercial potential. The anticipation of partnership developments later in the quarter suggests that Virios is seeking strategic alliances that could enhance the drug's development and distribution capabilities, potentially accelerating market access and uptake upon successful trial outcomes.
Investors will likely monitor the upcoming placebo-controlled study results closely, as they will serve as a near-term catalyst that could influence the company's stock performance. Positive data could attract partnership opportunities and increase investor confidence, while any setbacks might have a converse effect.
Financially, the implications of advancing IMC-2 into Phase 2 trials for Virios Therapeutics are multifaceted. The allocation of an unrestricted investigational grant to the Bateman Horne Center for the ongoing study reflects an investment in the drug's development that could yield high returns if the therapy proves to be effective. The explicit mention of potential partnership developments indicates that Virios is actively seeking capital-efficient ways to fund its research, which could involve risk-sharing mechanisms and could potentially mitigate the financial burden of clinical trials.
Moreover, the company's stock valuation could be significantly affected by the outcome of the Phase 2 program. Positive results could lead to an increase in stock value due to the enhanced prospects of commercialization and revenue generation. Conversely, unfavorable results or regulatory hurdles could negatively impact investor sentiment and stock value. Thus, the financial risk is inherently tied to the clinical and regulatory success of IMC-2.
It is also important for investors to consider the typical volatility associated with biotech stocks, especially those in the development stage. The long-term financial outlook will depend on the ability of IMC-2 to meet clinical endpoints, secure FDA approval and capture market share in a competitive therapeutic landscape.
- Placebo-Controlled Clinical Proof of Concept Data Expected in Mid-2024 -
- Targeting Initiation of IMC-2 Phase 2 program in 2H 2024 -
ATLANTA, Jan. 22, 2024 (GLOBE NEWSWIRE) -- 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 plans for advancing IMC-2 (combination of valacyclovir and celecoxib) as a treatment for the fatigue, orthostatic intolerance and other symptoms associated with LC, also known as post-acute sequelae of SARS-CoV-2 infection (“PASC”). The Company is targeting the initiation of a Phase 2 program in the second half of 2024, with data expected in 2025.
“We believe the profound unmet medical need associated with LC symptoms provides a unique and timely opportunity for Virios to advance our combination therapy, IMC-2,” said Greg Duncan, Chairman and CEO of Virios Therapeutics. “There are currently no FDA-approved LC treatments, thus IMC-2 has potential to be one of the first therapies for addressing LC symptoms. With FDA agreement that fatigue reduction can serve as the primary endpoint in this program, success on the LC indication may allow extension to other fatigue related illnesses such as Chronic Fatigue Syndrome, thereby expanding our potential market opportunity.”
“Virios has provided the Bateman Horne Center with an unrestricted investigational grant to fund their ongoing placebo-controlled 12-week study of the valacyclovir/celecoxib combination in up to 60 LC patients, with data expected by mid-year 2024. In addition, we have received input from the FDA on development requirements and key endpoints associated with advancing IMC-2 into Phase 2 development as a treatment for LC symptoms. We are now taking the organizational steps necessary to prepare for the initiation of a Phase 2 clinical program in the second half of this year. We further expect to provide an update on potential partnership developments later this quarter,” Duncan concluded.
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 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.
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