Virios Therapeutics Announces Research Collaboration Exploring the Potential of Combination Antiviral Therapy for Treating Long COVID

On Mar 1, 2022

Virios Therapeutics, Inc. a development-stage biotechnology company focused on advancing novel antiviral therapies to treat chronic diseases, including fibromyalgia, announced a collaboration with the Bateman Horne Center (“BHC”) of Salt Lake City, Utah, to explore the role of combination antiviral therapy in Long COVID, otherwise known as Post-Acute Sequelae of COVID-19 . The Bateman Horne Center is a non-profit, interdisciplinary Center of Excellence advancing the diagnosis and treatment of myalgic encephalomyelitis/chronic fatigue syndrome (“ME/CFS”), fibromyalgia (“FM”), post-viral syndromes, and related comorbidities.

Virios Therapeutics, Inc. is providing BHC with an unrestricted grant for an investigator-sponsored study to explore the therapeutic potential of combination antiviral therapy with Virios’ second development candidate, IMC-2. The study will evaluate changes in common Long COVID symptoms such as fatigue, sleep, attention, pain, autonomic function and anxiety.

“We are pleased to support the Bateman Horne Center, a leading clinical research center in post-viral syndromes, as they study the therapeutic potential of IMC-2 to ease the burden of Long COVID, which is an emerging healthcare crisis,” said Greg Duncan, Chairman and CEO of Virios Therapeutics Inc.

According to the World Health Organization, COVID-19 has caused more than 373 million infections and more than 5.6 million deaths as of January 2022. Published estimates in the scientific literature suggest that up to 30% will experience Long COVID symptoms. It is estimated that one in three patients who develop Long COVID symptoms were asymptomatic during their acute COVID-19 infection. The mechanisms by which COVID-19 causes lingering symptoms are not well understood. Potential triggers for long term symptoms might include:

Immune-system dysregulation triggered by the COVID-19 virus, including increased production of autoantibodies,
Lingering or re-infection with COVID-19 variants, and
Co-infection or activation of previous viral infections that had become dormant

“Most adults are infected with normally harmless dormant viruses contracted years earlier,” said R. Michael Gendreau, M.D., Ph.D., Chief Medical Officer of Virios Therapeutics. “It is becoming increasingly clear that COVID-19 acutely depresses our immune system, which may allow for reactivation of neurotrophic pathogens such as viruses in the herpes family.”

Virios’ lead antiviral development candidate, orally administered IMC-1, is a novel, proprietary, fixed dose, antiviral therapy combining famciclovir and celecoxib. The ongoing Phase 2b FORTRESS study is a randomized, double-blind evaluation of IMC-1 in patients with FM. The FORTRESS study builds on the statistically significant results from the Company’s previously completed Phase 2a FM clinical study. The 143-patient Phase 2a trial demonstrated that IMC-1 met its primary endpoint of pain reduction and was statistically better tolerated than placebo.

The Company’s dual mechanism antiviral development candidates are designed to synergistically suppress herpes virus activation and replication. The uniqueness of this approach has garnered IMC-1 “fast track” designation by the U.S. Food and Drug Administration (“FDA”), the first of its kind for a new FM development candidate.