How are Herpes Viruses Potentially Implicated in Fibromyalgia, As Well As Both Fatigue and Gastroint

Nearly four billion people around the world are infected with herpes viruses. Herpes viruses are highly contagious, and most people who become infected are asymptomatic and unaware that they have been infected with a Herpes virus. It is possible to have been infected with multiple different Herpes viruses over the course of a lifetime. Herpes viruses that commonly infect people and remain dormant in the nervous system include Human Herpes Virus-1 (HHV-1, also commonly referred to as HSV-1), HHV-4 (EBV), HHV-5 (CMV, cytomegalovirus virus) and HHV-3 (Herpes varicella-zoster), the virus that causes chickenpox and shingles. Virios Therapeutics (Nasdaq: VIRI) hypothesizes that resident herpes viruses may remain dormant for months or years before reactivating in response to decreased immune surveillance due to stress, genetics or other factors. The Company believes activated herpes viruses may trigger or maintain conditions such as fibromyalgia (FM), chronic fatigue and GI related disorders.

VIRI believes a growing body of both clinical and mechanistic research supports this hypothesis. VIRI’s lead development candidate, IMC-1, is a combination antiviral treatment that has been specifically designed to convert activated replicating herpes viruses back into a dormant state. This, in turn, allows a patient’s immune response to reset, with the hope that symptoms will then improve as a result. As evidence of this thesis in action, in a Phase 2a clinical study, orally administered IMC-1 demonstrated significant FM related pain reduction, improved patient health and was tolerated as well as placebo in patients diagnosed with FM.

Antiviral therapy

As a physician who specialized in GI disorders including gastrointestinal reflux, ulcers and irritable bowel, I saw a large number of patients with pain and fatigue that was not explained by any obvious physical or laboratory findings. In 2002, I noticed that many of my patients with gastrointestinal (GI) issues had recurring symptoms that appeared to get worse during times of stress. It seemed clear to me that these symptoms could be caused by reactivation of a previous herpes virus infection, especially in light of the waxing and waning nature of patients’ symptoms. I began prescribing antiviral drugs, which not only improved patients’ GI symptoms, but in many patients resolved other symptoms including depression, fatigue and pain. These insights and experiences led me to form Innovative Med Concepts, which later transformed into Virios Therapeutics, Inc.

The Virios Therapeutics Research Pipeline

The Company has secured intellectual property protection for a pipeline of combination antiviral development candidates. Our lead development candidate, IMC-1, is a novel, proprietary, fixed dose combination of famciclovir and celecoxib designed to synergistically suppress herpes virus replication, with the end goal of reducing virally promoted disease symptoms. 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 trial (“FORTRESS”), designed to potentially serve as a supportive registrational study. Evidence of IMC-1’s efficacy on a broad spectrum of FM outcome measures was demonstrated in a previous Phase 2a clinical study. The Company is pursuing a second development candidate, IMC-2 (valacyclovir and celecoxib), as a potential treatment for managing the fatigue, poor sleep, pain, autonomic dysfunction and anxiety associated with Long COVID, otherwise known as Post-Acute Sequelae of COVID-19 (PASC). The Company has provided Bateman Horne Center with an unrestricted investigational grant to conduct this study on a cohort of PASC patients.

What’s next?

Virios Therapeutics, Inc. recently announced that it has completed enrollment in its Phase 2b FORTRESS (Fibromyalgia Outcome Research Trial Evaluating Synergistic Suppression of Herpes Simplex Virus study), which is a follow-up randomized, double-blind evaluation of IMC-1 in patients with FM. If results from the ongoing FORTRESS study are consistent with the previously completed Phase 2a study, we believe that IMC-1 has the potential to be a novel new treatment for the millions of patients across the globe living with FM, many of whom are looking for safe and effective new therapies.