Virios Therapeutics Announces Completion of Enrollment in IMC-2 Phase 2 Long-COVID Study Being Conducted by Bateman Horne Center
Virios Therapeutics (Nasdaq: VIRI) announced the completion of enrollment in a Phase 2 Long-COVID study for IMC-2, conducted by Bateman Horne Center. The study evaluates the combination of valacyclovir and celecoxib as a treatment for Long-COVID symptoms. Top line results are expected in October 2024.
The randomized, double-blind, placebo-controlled study follows a positive prior proof of concept study showing improvements in fatigue, pain, and other symptoms. Virios believes that activated herpes viruses may trigger or maintain Long-COVID and fibromyalgia. With an estimated 45 million potential adult patients affected by Long-COVID in the U.S., and no FDA-approved treatments available, Virios' antiviral combination could be a significant breakthrough.
Virios Therapeutics (Nasdaq: VIRI) ha annunciato il completamento dell'arruolamento in uno studio di Fase 2 sul Long-COVID per IMC-2, condotto dal Bateman Horne Center. Lo studio valuta la combinazione di valaciclovir e celecoxib come trattamento per i sintomi del Long-COVID. I risultati preliminari sono attesi per ottobre 2024.
Lo studio randomizzato, doppio cieco e controllato con placebo segue un precedente studio di prova di concetto positivo che ha mostrato miglioramenti nella fatica, nel dolore e in altri sintomi. Virios crede che i virus herpes attivati possano scatenare o mantenere il Long-COVID e la fibromialgia. Con un numero stimato di 45 milioni di potenziali pazienti adulti colpiti dal Long-COVID negli Stati Uniti e nessun trattamento approvato dalla FDA disponibile, la combinazione antivirale di Virios potrebbe rappresentare una svolta significativa.
Virios Therapeutics (Nasdaq: VIRI) anunció la finalización de la inscripción en un estudio de Fase 2 sobre Long-COVID para IMC-2, llevado a cabo por el Bateman Horne Center. El estudio evalúa la combinación de valaciclovir y celecoxib como tratamiento para los síntomas de Long-COVID. Se esperan resultados preliminares en octubre de 2024.
El estudio es aleatorizado, doble ciego y controlado con placebo, y sigue a un estudio de prueba de concepto previo que mostró mejoras en la fatiga, el dolor y otros síntomas. Virios cree que los virus herpes activados pueden desencadenar o mantener el Long-COVID y la fibromialgia. Con un estimado de 45 millones de pacientes adultos potenciales afectados por Long-COVID en los EE.UU. y sin tratamientos aprobados por la FDA disponibles, la combinación antiviral de Virios podría ser un avance significativo.
Virios Therapeutics (Nasdaq: VIRI)는 Bateman Horne Center에 의해 진행된 IMC-2에 대한 롱코비드 2상 연구의 등록 완료를 발표했습니다. 이 연구는 롱코비드 증상의 치료로서 발라시클로버와 셀레코시브의 조합을 평가합니다. 최종 결과는 2024년 10월에 발표될 예정입니다.
이 연구는 무작위화, 이중 맹검, 플라시보 대조로 수행되며, 피로, 통증 및 기타 증상 개선을 보여준 긍정적인 이전 개념 증명 연구를 따릅니다. Virios는 활성화된 헤르페스 바이러스가 롱코비드 및 섬유근육통을 유발하거나 유지할 수 있다고 믿고 있습니다. 미국에서 롱코비드에 영향을 받는 성인 환자가 4500만 명 이상으로 추정되며, FDA에서 승인된 치료제가 없는 상황에서 Virios의 항바이러스 조합은 중요한 혁신이 될 수 있습니다.
Virios Therapeutics (Nasdaq: VIRI) a annoncé l'achèvement de l'inscription dans une étude de Phase 2 sur le Long-COVID pour IMC-2, réalisée par le Bateman Horne Center. L'étude évalue la combinaison de valacyclovir et de célécoxib comme traitement des symptômes du Long-COVID. Les résultats préliminaires sont attendus en octobre 2024.
L'étude, randomisée, en double aveugle et contrôlée par placebo, fait suite à une étude de preuve de concept précédente montrant des améliorations de la fatigue, de la douleur et d'autres symptômes. Virios croit que les virus herpétiques activés peuvent déclencher ou maintenir le Long-COVID et la fibromyalgie. Avec environ 45 millions de patients adultes potentiels touchés par le Long-COVID aux États-Unis et aucun traitement approuvé par la FDA disponible, la combinaison antivirale de Virios pourrait constituer une avancée significative.
Virios Therapeutics (Nasdaq: VIRI) gab bekannt, dass die Rekrutierung für eine Phase-2-Studie zu Long-COVID für IMC-2, die vom Bateman Horne Center durchgeführt wird, abgeschlossen ist. Die Studie bewertet die Kombination von Valaciclovir und Celecoxib als Behandlung für Long-COVID-Symptome. Die vorläufigen Ergebnisse werden im Oktober 2024 erwartet.
Die randomisierte, doppelblinde, placebo-kontrollierte Studie folgt auf eine positive vorherige Machbarkeitsstudie, die Verbesserungen bei Müdigkeit, Schmerzen und anderen Symptomen zeigte. Virios ist überzeugt, dass aktivierte Herpesviren Long-COVID und Fibromyalgie auslösen oder aufrechterhalten können. Mit geschätzten 45 Millionen potenziellen erwachsenen Patienten, die in den USA von Long-COVID betroffen sind, und ohne von der FDA genehmigte Behandlungen könnte die antivirale Kombination von Virios einen bedeutenden Durchbruch darstellen.
- Completion of enrollment in Phase 2 Long-COVID study for IMC-2
- Positive results from prior proof of concept study showing symptom improvements
- Potential to address a large market of 45 million adult patients with Long-COVID in the U.S.
- No FDA-approved treatments currently available for Long-COVID symptoms
- Top line results not expected until October 2024
- Competitive landscape may change before study results are available
- Uncertain regulatory pathway for Long-COVID treatments
Insights
The completion of enrollment in the IMC-2 Phase 2 Long-COVID study is a significant step forward in the battle against Long-COVID. The study's combination of valacyclovir and celecoxib targets Epstein-Barr virus (EBV), which is thought to be reactivated in Long-COVID patients. This particular focus is backed by published data indicating that increased EBV levels are commonly found in these patients.
The use of a double-blind, placebo-controlled setup adds robustness to the study's design, ensuring that the results will be scientifically reliable. Importantly, this study is positioned as a potential game-changer, especially given the lack of FDA-approved treatments for Long-COVID symptoms. The upcoming release of top-line data in October 2024 will be crucial. If positive, this could validate the antiviral approach and pave the way for further clinical trials and eventual FDA approval.
Overall, the impact could be significant, setting new standards for Long-COVID treatment and potentially expanding the therapeutic use of antiviral agents like valacyclovir in chronic diseases.
This news is highly relevant from a market perspective. The initial completion of enrollment in this study suggests that Virios Therapeutics is on track with its research timelines, enhancing investor confidence. The mention of a sizable target market—nearly 45 million potential adult patients in the U.S. alone—indicates substantial commercial potential.
Investors should watch for the upcoming release of top-line data. Positive results could significantly boost the company's market valuation and open doors for strategic partnerships or acquisitions. Additionally, the unmet need in Long-COVID treatment offers a unique market opportunity. This news positions Virios as a frontrunner in an emerging and highly impactful therapeutic area.
From a financial standpoint, this development is a positive indicator for Virios Therapeutics. The company's strategic focus on unmet needs in chronic diseases like Long-COVID and fibromyalgia has the potential to attract both market and investor attention. The completion of the Phase 2 study enrollment suggests steady progress, which is important for a development-stage biotech firm.
The upcoming October 2024 release of top-line data is a key financial milestone. Positive results can lead to increased market capitalization, better funding opportunities and even potential collaborations or licensing deals. Additionally, the failure of Paxlovid in treating Long-COVID symptoms adds weight to Virios’ approach, potentially reducing competition in this niche market.
- Virios projects releasing top line results from this groundbreaking Proof of Concept study in October 2024 -
- 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, July 23, 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 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
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.
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FAQ
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