VIRI Virios Therapeutics Inc.

5.95
+0.16  (+3%)
Previous Close 5.79
Open 5.69
52 Week Low 4.6
52 Week High 16.71
Market Cap $49,565,821
Shares 8,330,390
Float 6,616,974
Enterprise Value $53,292,514
Volume 18,842
Av. Daily Volume 123,560
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Upcoming Catalysts

Drug Stage Catalyst Date
IMC-1 (FORTRESS)
Fibromyalgia
Phase 2b
Phase 2b
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Drug Pipeline

Drug Stage Notes
IMC-1
Irritable bowel syndrome (IBS)
Phase 2
Phase 2
Phase 2 trial planned.

Latest News

  1. Virios Therapeutics, Inc. (Nasdaq: VIRI), a clinical-stage biotechnology company focused on advancing novel antiviral therapies to treat chronic pain and fatigue related diseases, announced today that all 41 sites involved in its ongoing 460 patient Phase 2b fibromyalgia (FM) trial are now fully activated and enrolling patients. This trial builds on the encouraging results from the Company's previously completed IMC-1 phase 2a FM clinical study. The 143-patient Phase 2a trial demonstrated that VIRI's lead antiviral development candidate, orally administered IMC-1, met its primary endpoint of pain reduction and was statistically better tolerated than placebo.

    IMC-1 is a novel, proprietary, fixed dose, antiviral therapy combining famciclovir…

    Virios Therapeutics, Inc. (Nasdaq: VIRI), a clinical-stage biotechnology company focused on advancing novel antiviral therapies to treat chronic pain and fatigue related diseases, announced today that all 41 sites involved in its ongoing 460 patient Phase 2b fibromyalgia (FM) trial are now fully activated and enrolling patients. This trial builds on the encouraging results from the Company's previously completed IMC-1 phase 2a FM clinical study. The 143-patient Phase 2a trial demonstrated that VIRI's lead antiviral development candidate, orally administered IMC-1, met its primary endpoint of pain reduction and was statistically better tolerated than placebo.

    IMC-1 is a novel, proprietary, fixed dose, antiviral therapy combining famciclovir and celecoxib. This dual mechanism antiviral therapy is designed to synergistically suppress Herpes Simplex Virus-1 ("HSV-1") activation and replication. It is the Company's hypothesis that HSV-1 related immune responses can serve as a catalyst for symptoms commonly associated with FM, irritable bowel syndrome (IBS) and fatigue related disorders. This hypothesis is supported by both clinical and mechanistic data, the latter of which has suggested that HSV-1 is actively replicating in the tissue of patients diagnosed with FM and chronic GI disorders, such as IBS.

    "We are pleased that enrollment in our FORTRESS study is proceeding as planned and that all of our sites are now able to recruit patients," said Dr. R. Michael Gendreau, Virios' Chief Medical Officer.

    Dr. Gendreau continued, "Data from our prior clinical work has been presented in several recent medical meetings. These data demonstrate that in our Phase 2a FM trial, in addition to meeting the primary endpoint of significantly greater pain reduction compared with placebo, patients treated with IMC‑1 reported significantly greater improvement on the Revised Fibromyalgia Impact Questionnaire ("FIQ-R") total score showed significant improvement on all three of the FIQ‑R domains, and also showed statistical significance on the patient global impression of change (PGIC). In addition, treatment with IMC-1 was exceptionally well tolerated in this study. These secondary endpoint results, combined with excellent tolerability, suggest that IMC‑1 may represent a promising treatment option not only for alleviating pain, but also for improving other symptoms associated with FM, such as stiffness, sleep quality, depression, anxiety and fatigue."

    The Company anticipates reporting top line results from the currently enrolling FORTRESS Phase 2b FM trial in mid-2022.

    For more information, please visit www.virios.com.

    About IMC-1

    IMC-1 is a novel, proprietary, fixed dose combination of famciclovir and celecoxib. This dual mechanism antiviral therapy is designed to synergistically suppress HSV-1 activation and replication. IMC-1 combines two specific mechanisms of action purposely selected to inhibit HSV-1 activation and replication, thereby keeping HSV-1 in a latent (dormant) state or "down-regulating" HSV-1 from a lytic (active) state back to latency. The famciclovir component of IMC-1 inhibits viral DNA polymerase necessary for replication. The celecoxib component of IMC-1 inhibits both cyclooxegenase-2 ("COX-2") and COX-1 enzymes, used by HSV-1 to accelerate its own replication. Virios Therapeutics holds a U.S. "Composition of Matter" Synergistic Patent (US 10,251,853) for the synergistic combination for total daily dose of famciclovir and celecoxib.

    About Virios Therapeutics

    Virios Therapeutics (Nasdaq: VIRI) is a clinical-stage biotechnology company focused on advancing novel, dual mechanism antiviral therapies to treat conditions associated with virally triggered or maintained immune responses, such as fibromyalgia ("FM"). Immune responses related to the activation of tissue resident Herpes Simplex Virus-1 ("HSV-1") have been postulated as a potential root cause triggering and/or sustaining chronic illnesses such as FM, irritable bowel disease ("IBS"), chronic fatigue syndrome and other functional somatic syndromes, all of which are characterized by waxing and waning symptoms with no obvious etiology. Our lead development candidate ("IMC-1") is a novel, proprietary, fixed dose combination of famciclovir and celecoxib designed to synergistically suppress HSV-1 replication.

    Evidence of IMC-1's efficacy on a broad spectrum of FM outcome measures was previously demonstrated in a Phase 2a clinical trial. These trial results are suggestive that IMC-1 may represent a new and novel treatment for fibromyalgia. IMC-1 has been granted fast track designation by the FDA and is currently being tested in a multi-center, randomized, double-blind, placebo-controlled 460 patient Phase 2b trial ("FORTRESS") designed to set the stage for registrational studies. The Company is led by an executive team highly experienced in the successful development and commercialization of novel therapies. For more information, please visit www.virios.com.

    Forward-Looking Statements

    Statements in this press release contain "forward-looking statements" 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 and timing of the Phase 2b trial. 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, 2020 filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Virios Therapeutics, Inc. (VIRI) undertakes no duty to update such information except as required under applicable law.

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  2. Virios Therapeutics, Inc. (Nasdaq: VIRI), a clinical-stage biotechnology company focused on advancing novel antiviral therapies to treat diseases associated with virally triggered or maintained immune responses, announced today that data from the company's Phase 2a clinical trial PRID-201 demonstrated that IMC-1 was better tolerated than placebo in patients with fibromyalgia ("FM"). This result is highlighted in a poster presentation at the International Association for the Study of Pain (IASP) World Congress, being held virtually June 9 - 11, 2021 and June 16 - 18, 2021.

    IMC-1 is a novel, proprietary, fixed dose, antiviral therapy combining famciclovir and celecoxib. This dual mechanism antiviral therapy is designed to synergistically suppress…

    Virios Therapeutics, Inc. (Nasdaq: VIRI), a clinical-stage biotechnology company focused on advancing novel antiviral therapies to treat diseases associated with virally triggered or maintained immune responses, announced today that data from the company's Phase 2a clinical trial PRID-201 demonstrated that IMC-1 was better tolerated than placebo in patients with fibromyalgia ("FM"). This result is highlighted in a poster presentation at the International Association for the Study of Pain (IASP) World Congress, being held virtually June 9 - 11, 2021 and June 16 - 18, 2021.

    IMC-1 is a novel, proprietary, fixed dose, antiviral therapy combining famciclovir and celecoxib. This dual mechanism antiviral therapy is designed to synergistically suppress Herpes Simplex Virus-1 ("HSV-1") activation and replication, with the end goal of reducing viral mediated disease burden.

    "There is a clear medical need for new, safe and effective treatments with the potential to improve care for the estimated 10 - 20 million FM patients in the U.S. and more than 200 million worldwide," commented R. Michael Gendreau, M.D., Ph.D., Chief Medical Officer of Virios Therapeutics. "Our Phase 2a clinical trial data showed that IMC-1 treated patients had higher overall completion rates and lower rates of discontinuation due to adverse events, as compared with placebo-treated patients. This is an especially encouraging result when viewed in the background of current patient and provider dissatisfaction with the generally poor tolerability of existing approved FM treatments," concluded Dr. Gendreau.

    Title: The Safety of IMC‑1 in Patients with Fibromyalgia: Phase 2a Study Results

    Lead Author: William Pridgen, M.D., Tuscaloosa Surgical Associates

    Conclusions: IMC‑1 exhibited an encouraging safety profile, as AEs occurred at a lower rate and were less severe in the IMC‑1 treatment group compared with placebo. The discontinuation rate due to AEs was nearly 3‑fold higher in patients receiving placebo compared with patients receiving IMC‑1, suggesting that treatment with IMC‑1 was unusually well‑tolerated. In this study, IMC‑1 demonstrated significant reductions in pain, fatigue, and other important symptoms in patients with FM. These results suggest that IMC‑1 may offer a promising and well‑tolerated option to treat patients with FM.

    For more information, please visit www.virios.com.

    About IMC-1

    IMC-1 is a novel, proprietary, fixed dose combination of famciclovir and celecoxib. This dual mechanism antiviral therapy is designed to synergistically suppress HSV-1 activation and replication, with the end goal of reducing viral mediated disease burden. IMC-1 combines two specific mechanisms of action purposely selected to inhibit HSV-1 activation and replication, thereby keeping HSV-1 in a latent (dormant) state or "down-regulating" HSV-1 from a lytic (active) state back to latency. The famciclovir component of IMC-1 inhibits viral DNA polymerase necessary for replication. The celecoxib component of IMC-1 inhibits both cyclooxegenase-2 ("COX-2") and COX-1 enzymes, used by HSV-1 to accelerate its own replication. Virios Therapeutics holds a U.S. "Composition of Matter" Synergistic Patent (US 10,251,853) for the synergistic combination for total daily dose of famciclovir and celecoxib.

    About Virios Therapeutics

    Virios Therapeutics (Nasdaq: VIRI) is a clinical-stage biotechnology company focused on advancing novel, dual mechanism antiviral therapies to treat conditions associated with virally triggered or maintained immune responses, such as fibromyalgia ("FM"). Immune responses related to the activation of tissue resident Herpes Simplex Virus-1 ("HSV-1") have been postulated as a potential root cause triggering and/or sustaining chronic illnesses such as FM, irritable bowel disease ("IBS"), chronic fatigue syndrome and other functional somatic syndromes, all of which are characterized by waxing and waning symptoms with no obvious etiology. Our lead development candidate ("IMC-1") is a novel, proprietary, fixed dose combination of famciclovir and celecoxib designed to synergistically suppress HSV-1 replication, with the end goal of reducing virally promoted disease symptoms.

    Evidence of IMC-1's efficacy on a broad spectrum of FM outcome measures was previously demonstrated in a Phase 2a clinical trial. These trial results are suggestive that IMC-1 may represent a new and novel treatment for fibromyalgia. IMC-1 has been granted fast track designation by the FDA and is currently being tested in a multi-center, randomized, double-blind, placebo-controlled Phase 2b trial ("FORTRESS") designed to set the stage for registrational studies. The company is led by an executive team highly experienced in the successful development and commercialization of novel therapies. For more information, please visit www.virios.com.

    Forward-Looking Statements

    Statements in this press release contain "forward-looking statements" 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," "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 and timing of the Phase 2b trial. 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, 2020 filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Virios Therapeutics, Inc. (VIRI) undertakes no duty to update such information except as required under applicable law.

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  3. Virios Therapeutics, Inc. (Nasdaq: VIRI), a clinical-stage biotechnology company focused on advancing novel antiviral therapies to treat diseases associated with virally triggered or maintained immune responses, announced today dosing of the first patient in its Phase 2b clinical trial, referred to as FORTRESS (Fibromyalgia Outcome Research Trial Evaluating Synergistic Suppression of HSV-1), evaluating IMC-1 in patients with fibromyalgia.

    IMC-1 is a novel, proprietary, fixed dose, antiviral therapy combining famciclovir and celecoxib. This dual mechanism antiviral therapy is designed to synergistically suppress Herpes Simplex Virus-1 ("HSV-1") activation and replication, with the end goal of reducing viral mediated disease burden.

    "There…

    Virios Therapeutics, Inc. (Nasdaq: VIRI), a clinical-stage biotechnology company focused on advancing novel antiviral therapies to treat diseases associated with virally triggered or maintained immune responses, announced today dosing of the first patient in its Phase 2b clinical trial, referred to as FORTRESS (Fibromyalgia Outcome Research Trial Evaluating Synergistic Suppression of HSV-1), evaluating IMC-1 in patients with fibromyalgia.

    IMC-1 is a novel, proprietary, fixed dose, antiviral therapy combining famciclovir and celecoxib. This dual mechanism antiviral therapy is designed to synergistically suppress Herpes Simplex Virus-1 ("HSV-1") activation and replication, with the end goal of reducing viral mediated disease burden.

    "There is currently widespread dissatisfaction among fibromyalgia patients, healthcare providers and payers with the existing FDA approved medications for the management of fibromyalgia, most notably related to their generally poor tolerability," commented R. Michael Gendreau, M.D., Ph.D., Chief Medical Officer of Virios Therapeutics. "We are excited about the FORTRESS trial as we are testing optimized doses of IMC-1, and we will be measuring patients' fibromyalgia related pain on a daily basis. Based on industry standard fibromyalgia patient recruitment rates, we expect to complete the trial and announce top line results in mid-2022."

    "The dosing of the first patient in this Phase 2b trial marks an important milestone for Virios, as we develop new, combination antiviral therapies to improve care standards for patients suffering from chronic diseases like fibromyalgia and irritable bowel syndrome," said Greg Duncan, Chairman and Chief Executive Officer of Virios Therapeutics. "Virios has a unique potential to create significant value in meeting the medical need for a new, safe and effective treatment to help the large market of 10-20 million fibromyalgia patients in the U.S. and more than 200 million worldwide."

    About IMC-1

    IMC-1 is a novel, proprietary, fixed dose combination of famciclovir and celecoxib. This dual mechanism antiviral therapy is designed to synergistically suppress HSV-1 activation and replication, with the end goal of reducing viral mediated disease burden. IMC-1 combines two specific mechanisms of action purposely selected to inhibit HSV-1 activation and replication, thereby keeping HSV-1 in a latent (dormant) state or "down-regulating" HSV-1 from a lytic (active) state back to latency. The famciclovir component of IMC-1 inhibits viral DNA polymerase necessary for replication. The celecoxib component of IMC-1 inhibits both cyclooxegenase-2 ("COX-2") and COX-1 enzymes, used by HSV-1 to accelerate its own replication. Virios Therapeutics holds a U.S. "Composition of Matter" Synergistic Patent (US 10,251,853) for the synergistic combination for total daily dose of famciclovir and celecoxib.

    About the IMC-1 Phase 2b Clinical Trial

    Virios Therapeutics is conducting FORTRESS (Fibromyalgia Outcome Research Trial Evaluating Synergistic Suppression of HSV-1). This randomized, double-blind, multi-center, placebo-controlled Phase 2b trial is expected to enroll approximately 460 patients aged 18-65, all of whom having been diagnosed using the 2016 American College of Rheumatology diagnostic criteria for fibromyalgia. The primary endpoint for this trial will focus on reduction in pain over time, as measured daily by the Numerical Rating Scale ("NRS") 24-Hour Recall scale via an electronic diary that the patient will use at home for sixteen weeks. In addition to assessing patient's pain reduction, secondary endpoints will include change in fatigue, sleep disturbance, global health status, and patient function.

    About Virios Therapeutics

    Virios Therapeutics (Nasdaq: VIRI) is a clinical-stage biotechnology company focused on advancing novel, dual mechanism antiviral therapies to treat conditions associated with virally triggered or maintained immune responses, such as fibromyalgia ("FM"). Immune responses related to the activation of tissue resident Herpes Simplex Virus-1 ("HSV-1") have been postulated as a potential root cause triggering and/or sustaining chronic illnesses such as FM, irritable bowel disease ("IBS"), chronic fatigue syndrome and other functional somatic syndromes, all of which are characterized by waxing and waning symptoms with no obvious etiology. Our lead development candidate ("IMC-1") is a novel, proprietary, fixed dose combination of famciclovir and celecoxib designed to synergistically suppress HSV-1 replication, with the end goal of reducing virally promoted disease symptoms.

    Evidence of IMC-1's efficacy on a broad spectrum of FM outcome measures was previously demonstrated in a Phase 2a clinical trial. These trial results are suggestive that IMC-1 may represent a new and novel treatment for fibromyalgia. IMC-1 has been granted fast track designation by the FDA and is currently being tested in a multi-center, randomized, double-blind, placebo-controlled Phase 2b trial ("FORTRESS") designed to set the stage for registrational studies. The company is led by an executive team highly experienced in the successful development and commercialization of novel therapies. For more information, please visit www.virios.com.

    Forward-Looking Statements

    Statements in this press release contain "forward-looking statements" 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," "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 and timing of the Phase 2b trial. 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, 2020 filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Virios Therapeutics, Inc. (VIRI) undertakes no duty to update such information except as required under applicable law.

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  4. Virios Therapeutics, Inc. (Nasdaq: VIRI), a clinical-stage biotechnology company focused on advancing novel antiviral therapies to treat diseases associated with virally triggered or maintained immune responses, announced today that clinical data from its Phase 2a trial of IMC-1 in fibromyalgia ("FM") is featured in a poster presentation (poster POS0017) at the annual EULAR European Congress of Rheumatology, a renowned forum for interaction between medical doctors, scientists, people with arthritis/rheumatism, health professionals and representatives of the pharmaceutical industry worldwide, which is being held virtually June 2 - 5, 2021. The company's poster has been selected to be highlighted in a guided tour entitled "Epidemiology and treatment…

    Virios Therapeutics, Inc. (Nasdaq: VIRI), a clinical-stage biotechnology company focused on advancing novel antiviral therapies to treat diseases associated with virally triggered or maintained immune responses, announced today that clinical data from its Phase 2a trial of IMC-1 in fibromyalgia ("FM") is featured in a poster presentation (poster POS0017) at the annual EULAR European Congress of Rheumatology, a renowned forum for interaction between medical doctors, scientists, people with arthritis/rheumatism, health professionals and representatives of the pharmaceutical industry worldwide, which is being held virtually June 2 - 5, 2021. The company's poster has been selected to be highlighted in a guided tour entitled "Epidemiology and treatment of pain in Rheumatic and Musculoskeletal Disorders."

    IMC-1 is a novel, proprietary, fixed dose, antiviral therapy combining famciclovir and celecoxib. This dual mechanism antiviral therapy is designed to synergistically suppress Herpes Simplex Virus-1 ("HSV-1") activation and replication, with the end goal of reducing viral mediated disease burden.

    "Given that FM is associated with a broad spectrum of symptoms beyond pain, it is important to understand the impact of IMC‑1 on other FM‑related symptoms," commented R. Michael Gendreau, M.D., Ph.D., Chief Medical Officer of Virios Therapeutics. "In our Phase 2a FM trial, in addition to meeting the primary endpoints of greater tolerability and significantly greater pain reduction compared with placebo, patients treated with IMC‑1 reported significantly greater improvement compared with placebo on the Revised Fibromyalgia Impact Questionnaire ("FIQ-R") total score and on all three FIQ‑R domains. These secondary endpoint results suggest that IMC‑1 may represent a promising treatment option not only for alleviating pain, but also for improving other symptoms associated with FM, such as stiffness, sleep quality, depression, anxiety and fatigue," surmised Dr. Gendreau.

    Title: IMC‑1, a Fixed Dose Combination of Famciclovir and Celecoxib, Improves Common Symptoms Associated with Fibromyalgia in Addition to Pain: Post Hoc Analysis of a Phase 2a Trial

    Lead Author: William Pridgen, M.D., Tuscaloosa Surgical Associates

    Conclusions: In this post hoc analysis of a Phase 2a trial of IMC‑1 in patients with FM, patients treated with IMC‑1 reported significantly greater improvement compared with placebo on FIQ‑R total scores and on all FIQ‑R domains. Patients receiving IMC‑1 treatment reported significantly greater improvements versus placebo on the FIQ‑R symptom items for stiffness, sleep quality, depression, and anxiety. Improvements in patient global assessments and in fatigue assessments provide additional evidence for the beneficial effects of IMC‑1 on FM related symptoms. These results suggest that IMC‑1 may represent a promising treatment option not only for alleviating pain, but also for improving other symptoms associated with FM.

    For more information, please visit www.virios.com.

    About IMC-1

    IMC-1 is a novel, proprietary, fixed dose combination of famciclovir and celecoxib. This dual mechanism antiviral therapy is designed to synergistically suppress HSV-1 activation and replication, with the end goal of reducing viral mediated disease burden. IMC-1 combines two specific mechanisms of action purposely selected to inhibit HSV-1 activation and replication, thereby keeping HSV-1 in a latent (dormant) state or "down-regulating" HSV-1 from a lytic (active) state back to latency. The famciclovir component of IMC-1 inhibits viral DNA polymerase necessary for replication. The celecoxib component of IMC-1 inhibits both cyclooxegenase-2 ("COX-2") and COX-1 enzymes, used by HSV-1 to accelerate its own replication. Virios Therapeutics holds a U.S. "Composition of Matter" Synergistic Patent (US 10,251,853) for the synergistic combination for total daily dose of famciclovir and celecoxib.

    About Virios Therapeutics

    Virios Therapeutics (Nasdaq: VIRI) is a clinical-stage biotechnology company focused on advancing novel, dual mechanism antiviral therapies to treat conditions associated with virally triggered or maintained immune responses, such as fibromyalgia ("FM"). Immune responses related to the activation of tissue resident Herpes Simplex Virus-1 ("HSV-1") have been postulated as a potential root cause triggering and/or sustaining chronic illnesses such as FM, irritable bowel disease ("IBS"), chronic fatigue syndrome and other functional somatic syndromes, all of which are characterized by waxing and waning symptoms with no obvious etiology. Our lead development candidate ("IMC-1") is a novel, proprietary, fixed dose combination of famciclovir and celecoxib designed to synergistically suppress HSV-1 replication, with the end goal of reducing virally promoted disease symptoms.

    Evidence of IMC-1's efficacy on a broad spectrum of FM outcome measures was previously demonstrated in a Phase 2a clinical trial. These trial results are suggestive that IMC-1 may represent a new and novel treatment for fibromyalgia. IMC-1 has been granted fast track designation by the FDA and is currently being tested in a multi-center, randomized, double-blind, placebo-controlled Phase 2b trial ("FORTRESS") designed to set the stage for registrational studies. The company is led by an executive team highly experienced in the successful development and commercialization of novel therapies. For more information, please visit www.virios.com.

    Forward-Looking Statements

    Statements in this press release contain "forward-looking statements" 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," "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 and timing of the Phase 2b trial. 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, 2020 filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Virios Therapeutics, Inc. (VIRI) undertakes no duty to update such information except as required under applicable law.

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  5. Virios Therapeutics, Inc. (Nasdaq: VIRI), a clinical-stage biotechnology company focused on advancing novel antiviral therapies to treat diseases associated with virally triggered or maintained immune responses, announced today that clinical data was highlighted in an oral presentation at Digestive Disease Week® ("DDW") 2021, the premier global meeting for physicians, researchers and industry in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery, which was held virtually May 21 – 23, 2021.

    "The data presented by Dr. Duffy comprised a tissue biopsy study jointly conducted between the University of Alabama and Virios Therapeutics," commented R. Michael Gendreau, M.D., Ph.D., Chief Medical Officer of Virios Therapeutics…

    Virios Therapeutics, Inc. (Nasdaq: VIRI), a clinical-stage biotechnology company focused on advancing novel antiviral therapies to treat diseases associated with virally triggered or maintained immune responses, announced today that clinical data was highlighted in an oral presentation at Digestive Disease Week® ("DDW") 2021, the premier global meeting for physicians, researchers and industry in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery, which was held virtually May 21 – 23, 2021.

    "The data presented by Dr. Duffy comprised a tissue biopsy study jointly conducted between the University of Alabama and Virios Therapeutics," commented R. Michael Gendreau, M.D., Ph.D., Chief Medical Officer of Virios Therapeutics. "The study examined gastric mucosa biopsies from three cohorts: patients with functional gastrointestinal disorders ("FGID"), patients with both FGID and fibromyalgia (FM), and control patients. Biopsy specimens were analyzed for the presence of active herpesvirus infections. As is discussed in the presentation, there was a marked increase in the presence of actively replicating herpes simplex virus type 1 (HSV-1) in gastric mucosal tissue from FGID and FGID + FM patient groups as compared to control patients."

    "This finding highlights the potential role of activated HSV-1 as a potential root cause of chronic gastrointestinal disorders. Furthermore, this presentation provides further visibility to the medical community on the potential utility of combination antiviral drug therapies, such as IMC-1, for patients with chronic illnesses such as fibromyalgia ("FM") and irritable bowel syndrome ("IBS"), which are characterized by waxing and waning manifestation of disease," concluded Dr. Gendreau."

    Session: Clinical Science Late-Breaking Abstract Plenary

    Title: Active Herpes Simplex Virus Type 1 Infection of the Gastric Mucosa is Associated with Functional Gastrointestinal Disorders: A Pilot Case-Control Study (Abstract # 3581012)

    Presenter: Carol Duffy, Ph.D., University of Alabama

    Conclusions: Analysis of gastric mucosa biopsies revealed a significant positive association between actively replicating gastric HSV-1 and multiple functional gastrointestinal disorders, with and without concomitant FM. FGIDs including IBS, functional dysphagia, and functional dyspepsia may be related to active HSV-1 infection. Further investigation into the prevalence and possible causal nature of this association is warranted.

    For more information, please visit www.virios.com.

    About IMC-1

    IMC-1 is a novel, proprietary, fixed dose combination of famciclovir and celecoxib. This dual mechanism antiviral therapy is designed to synergistically suppress Herpes Simplex Virus-1 ("HSV-1") activation and replication, with the end goal of reducing viral mediated disease burden. IMC-1 combines two specific mechanisms of action purposely selected to inhibit HSV-1 activation and replication, thereby keeping HSV-1 in a latent (dormant) state or "down-regulating" HSV-1 from a lytic (active) state back to latency. The famciclovir component of IMC-1 inhibits viral DNA polymerase necessary for replication. The celecoxib component of IMC-1 inhibits both cyclooxegenase-2 ("COX-2") and COX-1 enzymes, used by HSV-1 to accelerate its own replication. Virios Therapeutics holds a U.S. "Composition of Matter" Synergistic Patent (US 10,251,853) for the synergistic combination for total daily dose of famciclovir and celecoxib.

    About Virios Therapeutics

    Virios Therapeutics (Nasdaq: VIRI) is a clinical-stage biotechnology company focused on advancing novel, dual mechanism antiviral therapies to treat conditions associated with virally triggered or maintained immune responses, such as fibromyalgia ("FM"). Immune responses related to the activation of tissue resident Herpes Simplex Virus-1 ("HSV-1") have been postulated as a potential root cause triggering and/or sustaining chronic illnesses such as FM, irritable bowel disease ("IBS"), chronic fatigue syndrome and other functional somatic syndromes, all of which are characterized by waxing and waning symptoms with no obvious etiology. Our lead development candidate ("IMC-1") is a novel, proprietary, fixed dose combination of famciclovir and celecoxib designed to synergistically suppress HSV-1 replication, with the end goal of reducing virally promoted disease symptoms.

    Evidence of IMC-1's efficacy on a broad spectrum of FM outcome measures was previously demonstrated in a Phase 2a clinical trial. These trial results are suggestive that IMC-1 may represent a new and novel treatment for fibromyalgia. IMC-1 has been granted fast track designation by the FDA and is currently being tested in a multi-center, randomized, double-blind, placebo-controlled Phase 2b trial ("FORTRESS") designed to set the stage for registrational studies. The company is led by an executive team highly experienced in the successful development and commercialization of novel therapies. For more information, please visit www.virios.com.

    Forward-Looking Statements

    Statements in this press release contain "forward-looking statements" 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," "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 and timing of the Phase 2b trial. 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, 2020 filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Virios Therapeutics, Inc. (VIRI) undertakes no duty to update such information except as required under applicable law.

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