Virios Therapeutics - biotech company with anti-viral therapies for post-infection syndromes

Sly Saint

Sly Saint

Senior Member (Voting Rights)
ATLANTA--(BUSINESS WIRE)--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 Greg Duncan, Chairman and Chief Executive Officer, will present a company overview at the Benzinga Global Small Cap Conference on May 14, 2021 at 11:55 a.m. ET.
Click to expand...

The presentation will focus on the need for new approaches to treat fibromyalgia (“FM”), the novel antiviral approach being pursued by Virios Therapeutics, and the potential of IMC-1 as an FM treatment, based on positive results from a Phase 2 proof of concept clinical trial.

A link to the live and archived webcast of the presentation may be accessed on Virios Therapeutics’ website under the Investors section: Events and Presentations.
Click to expand...
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 2 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 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.
Click to expand...
https://www.pharmiweb.com/press-rel...t-at-the-benzinga-global-small-cap-conference
 
Virios currently holds 20 patents that include composition of matter, a unique synergy patent and method of use patents for FM, IBS & CFS patents. as well as Functional Somatic Syndrome (recently renamed the Somatic Symptom Disorder (SSD). These additional chronic conditions represent a substantially larger market opportunity. The below listed SSD conditions are all chronic-pain related conditions. Based on blinded survey data, we believe that many of the SSD conditions will be responsive to treatment with IMC-1.
https://www.virios.com/pipeline

1. Fibromyalgia

2. Irritable Bowel Syndrome

3. Chronic Pelvic Pain

4. Chronic Neck and Back Pain

5. Temporomandibular Joint Dysfunction (TMJ)

6. Frequent Headaches
 
This is the company begun from Skip Pridgen's protocols. He is on the board of Directors:

William L. Pridgen, M.D
William L. Pridgen, M.D. is our founder and has been a director since 2018. Dr. Pridgen is a board-certified surgeon practicing with Tuscaloosa Surgical Associates, P.C. in Tuscaloosa, Alabama. Dr. Pridgen obtained his B.S. in Biology from Rhodes College, attending the medical school and completing his surgical residency at the University of Tennessee College of Medicine. Dr. Pridgen is certified in general surgery and is a fellow of the American College of Surgeons. Dr. Pridgen has spent nearly 20 years searching for effective treatments in IBS, FM, and MECFS, and served as a physician and surgeon in the United States Navy for five years.
 
How could Somatic Symptom Disorder possibly be successfully and/or ethically be treated using antivirals - given that the definition excludes any biological cause for symptoms?

Or, is it just a case of lets make some money from the sickies (doesn't matter if it's ethical or might work)?

(I am aware that most, if not all, people diagnosed with SSD probably have a biological reason for their symptoms, just not ones that a GP or his favourite psychiatrist can be bothered to look for. It just puzzles me how people who have decided that there can be no biomedical explanation, who then diagnose SSD, can then be happy to offer antivirals - to the same patients).

Is this another have cake, eat it, and then still have all the cake scenario?
 
Last edited:
Virios Therapeutics’ Announces Dosing of First Patient in IMC-2 Long-COVID Treatment Trial

Virios Therapeutics, Inc. (Nasdaq: VIRI), a development-stage biotechnology company focused on advancing novel, combination antiviral therapies to treat debilitating chronic diseases, including fibromyalgia (“FM”), today announced commencement of enrollment in its exploratory Long-COVID trial. This study is supported via an unrestricted investigational grant to the Bateman Horne Center, a non-profit, interdisciplinary Center of Excellence advancing the diagnosis and treatment of myalgic encephalomyelitis/chronic fatigue syndrome (“ME/CFS”), FM, post-viral syndromes, and related comorbidities.

The trial will assess the safety and effectiveness of antiviral therapy with Virios’ second development combination, IMC-2 (valacyclovir + celecoxib), to treat the symptoms associated with Long-COVID, including fatigue, pain, sleep disruption, anxiety, depression and cognitive function and overall health improvement. IMC-2 is a novel, dual mechanism antiviral therapy combining valacyclovir and celecoxib designed to synergistically suppress herpes virus activation and replication, with the end goal of reducing viral mediated disease burden.

“The dosing of the first patient in this exploratory trial marks an important milestone for Virios, as we develop new combination antiviral therapies to improve care standards for patients suffering from virally mediated diseases,” said Greg Duncan, Chairman and Chief Executive Officer of Virios Therapeutics. “Virios has unique potential to create significant value in meeting the medical need for a new treatment that could help the estimated 100 million people worldwide who are suffering from Long-COVID symptoms.”
Click to expand...
https://www.theglobeandmail.com/inv...-patient-in-imc-2-long-covid-treatment-trial/
 
There doesn't seem to be anything in Clinical Trials for IMC-2 (there's one for IMC-002, but that seems to be a different treatment for a different disease and a different company). And yet the first patient is being dosed.

If anyone knows Lucinda Bateman, maybe they could ask her to ensure that the trial plan is lodged in the Clinical Trials register before the trial starts, for every trial that they have any involvement with? It's even more important when the trial is being done for a for-profit company.
The Bateman Horne Center must be turning a rather good profit by running these trials for speculative companies - which is fine, so long as they do a scrupulously great job. Pre-registration is surely a fundamental thing to do to avoid any suggestion of 'being able to be bought'.
 
press release
ATLANTA, Jan. 05, 2023 (GLOBE NEWSWIRE) -- Virios Therapeutics, Inc. (Nasdaq: VIRI), a development-stage biotechnology company focused on advancing novel, combination antiviral therapies to treat debilitating chronic diseases including fibromyalgia (“FM”), announced today that its end-of-Phase 2 meeting request with the U.S. Food and Drug Administration (“FDA”) to discuss advancing IMC-1 into Phase 3 development as a treatment for FM has been scheduled for mid-March 2023. At this meeting, the Company will discuss with the FDA plans for a Phase 3 program that would support submission of a new drug application for IMC-1 for the treatment of FM. The Company plans to provide a program update by the end of April following the receipt of formal written feedback from the FDA.

The Company believes the safety and efficacy results from its FORTRESS Phase 2b FM study support progression of IMC-1 to Phase 3 development for “new” patients, who represent the vast majority of the FM patient community.

Analysis of the Company’s recent FORTRESS Phase 2b FM study data revealed:

  • “New” FM patients treated with its novel FM development candidate, IMC-1 , who were recruited into FORTRESS via advertising, demonstrated statistically significant reductions in FM related pain, fatigue, anxiety and depressive symptoms and showed an overall improvement in their global health status.
  • In contrast, “experienced” FM patients (i.e. patients previously enrolled in FM studies and those with a prior relationship with the FORTRESS study sites), who in the Company’s view represent a more treatment refractory/resistant cohort of patients, did not exhibit meaningful treatment benefits.
  • “New” patients treated with IMC-1 also exhibited a lower discontinuation rate due to adverse events as compared with “new” patients receiving] placebo.
  • All patients treated with IMC-1 demonstrated exemplary safety and tolerability in the FORTRESS study.
Click to expand...
https://greenstocknews.com/news/nas...to-discuss-imc-1-fibromyalgia-phase-3-program
 
copied post
"This open-label, single-center, investigator-initiated study was conducted at the Bateman Horne Center (“BHC”) with an unrestricted investigational grant."

Virios Therapeutics Announces Positive Data Demonstrating Improvement in Multiple Long-COVID Symptoms Following Treatment with a Combination of Valacyclovir and Celecoxib in an Exploratory, Open-Label, Proof of Concept Study
ATLANTA, July 17, 2023 (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”), today announced that female patients diagnosed with Long-COVID illness, otherwise known as Post-Acute Sequelae of COVID-19 infection (“PASC”), exhibited clinically and statistically significant improvements in fatigue, pain, and symptoms of autonomic dysfunction and general well-being related to Long-COVID when treated open-label with a combination of valacyclovir and celecoxib (“Val/Cel”) for 14 weeks, as compared to a control cohort of female Long-COVID patients matched by age, gender and length of illness and treated with routine care. The statistically significant improvements in PASC symptoms and general health status were particularly encouraging given that the mean duration of Long-COVID illness was two years for both the treated and control cohort prior to enrollment in this trial.

This open-label, single-center, investigator-initiated study was conducted at the Bateman Horne Center (“BHC”) with an unrestricted investigational grant. BHC is a non-profit, interdisciplinary Center of Excellence advancing the diagnosis and treatment of chronic fatigue disorders including myalgic encephalomyelitis/chronic fatigue syndrome (“ME/CFS”), FM, post-viral syndromes, and related comorbidities.

Based on these data, the Company plans to meet with the Food and Drug Administration (“FDA”) in the second half of 2023 to discuss opening an investigational new drug application to formally assess treatment of symptoms associated with PASC using a fixed dose combination of valacyclovir and celecoxib.

Key Highlights

  • Female patients diagnosed with Long-COVID exhibited clinically and statistically significant improvements when comparing both within the Val/Cel cohort and between study cohorts in:
    • fatigue as measured with both the PROMIS fatigue instrument and a numeric rating scale (“NRS”) for fatigue,
    • pain as measured by a NRS scale for pain,
    • and in autonomic dysfunction symptoms as measured using the Orthostatic Intolerance Questionnaire.
  • Two different scales for Patient’s Global Impression of Change documented improvement in overall health when treated with open-label Val/Cel twice daily for 14 weeks.
  • Treatment with Val/Cel was generally well tolerated, with an observed safety profile consistent with the known safety profiles of valacyclovir and celecoxib. There were no serious adverse events observed in this study and only one treated patient discontinued treatment due to adverse events, possibly related to Val/Cel treatment. Among those patients receiving Val/Cel, nausea was the most common adverse event. The most common adverse events in the routine care group were headaches and muscle pain.
Click to expand...

https://www.globenewswire.com/news-...-of-Valacyclovir-and-Celecoxib-in-an-Exp.html
 
Last edited by a moderator:
Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain and help relieve symptoms of arthritis (eg, osteoarthritis, rheumatoid arthritis, or juvenile rheumatoid arthritis), such as inflammation, swelling, stiffness, and joint pain.
Click to expand...
Not surprising that celecoxib would help pain.

I'm skeptical of valacyclovir making a significant difference. It's been trialled in ME/CFS before.
Forum thread here:Antivirals as ME/CFS or Long Covid treatments (e.g. valacyclovir, valgancyclovir)

Still, it will be interesting to see the results of a blinded controlled study, so I hope they are able to do that. I hope they have treatment arms with each drug alone as well as combined. Even if a study just found that pain control improves quality of life, that would be useful.
 
These drugs have already been tried by so many patients for decades. What reason is there for not going straight to a blinded trial? Are they trying to milk unsophisticated investors?
 
Just thinking about the blinding - that will be difficult. It will be fairly obvious if someone is receiving the painkiller, so, if they don't have treatment arms with each drug individually and combined, then I don't think the blinding will be effective. There will be some people who get frequent cold sores, and so the blinding of valacyclovir will also be compromised.

I hope that Bateman Horne (if they run the blinded controlled study) will use some good objective outcomes, such as wearable technology for activity monitoring.
 
You must log in or register to reply here.
Back
Top Bottom