Virios Therapeutics Completes Enrollment in IMC-2 Phase 2 Long-COVID Study

Virios Therapeutics, Inc. (Nasdaq: VIRI), a company dedicated to developing novel antiviral treatments for chronic diseases such as fibromyalgia (FM) and Long-COVID (LC), announced that the Bateman Horne Center (BHC) has completed enrollment for its proof of concept study on LC. Preliminary results from this study are expected in October 2024.

The BHC study is a randomized, double-blind, placebo-controlled trial examining the effectiveness of a combination of valacyclovir and celecoxib (IMC-2) in treating fatigue and other LC symptoms. This study builds on an earlier investigation that showed the valacyclovir/celecoxib combination improved various symptoms such as fatigue, pain, orthostatic issues, anxiety, and overall health in LC patients compared to an untreated control group.

Greg Duncan, Chairman and CEO of Virios, commented on the potential significance of this treatment approach. He stated that herpes virus activation might play a role in triggering or sustaining conditions like LC and FM. He highlighted that their novel antiviral combination could significantly impact millions of LC patients who are in urgent need of effective treatments. Duncan also pointed out that this comes at a crucial time, especially given the recent negative outcomes from studies assessing Paxlovid as an LC treatment.

According to the 2024 National Center for Health Statistics Household Pulse Survey, 17.6% of the U.S. population—or nearly 45 million adults—have experienced LC since the onset of the COVID-19 pandemic in November 2019. Currently, there are no FDA-approved treatments specifically for LC symptoms, emphasizing the necessity for new therapeutic options.

Research indicates that LC emerges as a consequence of SARS-CoV-2 infection and is linked to immune system dysfunction and complement activation. It is suggested that the initial COVID-19 infection might weaken the immune system enough to allow dormant herpesviruses to reactivate. Reactivated viruses such as Epstein-Barr virus (EBV) are thought to contribute to fatigue and cognitive dysfunction, which are prevalent symptoms in LC patients.

Virios Therapeutics is focused on developing antiviral therapies aimed at treating diseases associated with an abnormal immune response triggered by viral infections, such as FM and LC. Overactive immune responses due to tissue-resident herpesvirus activation are believed to be potential root causes of chronic illnesses like FM, irritable bowel syndrome, LC, chronic fatigue syndrome, and other functional somatic syndromes. These conditions are characterized by fluctuating symptoms often triggered by events that compromise the immune system.

The company's leading development candidates are novel, proprietary, fixed-dose combinations of antiviral compounds and celecoxib. These combinations are designed to work synergistically to suppress herpesvirus replication, with the ultimate goal of reducing disease symptoms driven by viral activity. One of these combinations, IMC-1 (a fixed dosage combination of famciclovir and celecoxib), has been granted fast track designation by the FDA.