VIRI: Enrollment Complete in FORTRESS Trial; Results Expected in September 2022…

By David Bautz, PhD

NASDAQ:VIRI

READ THE FULL VIRI RESEARCH REPORT

Business Update

FORTRESS Trial Fully Enrolled; Topline Results in September 2022

On April 28, 2022, Virios Therapeutics, Inc. VIRI announced that it has completed enrollment of 425 fibromyalgia patients into the Phase 2b FORTRESS (Fibromyalgia Outcome Research Trial Evaluating Synergistic Suppression of Herpes Simplex Virus-1) trial, a randomized, double blind, placebo controlled study of IMC-1. The primary endpoint of the trial is reduction in pain and secondary endpoints include change in fatigue, sleep disturbance, global health status, and patient functionality (NCT04748705). An outline of the trial is shown below.

In parallel with the FORTRESS trial, Virios is continuing the chronic toxicology studies of IMC-1 in two animal species. The results of these studies are required by regulators before Virios will be allowed to dose patients for one year or more, which is the plan for the Phase 3 program. The results of the chronic toxicology studies should be known around the time of the completion of the FORTRESS trial, thus the company should be able to move into a final Phase 3 program following completion of the current study, pending positive results.

Testing Combination Antiviral Therapy for the Treatment of Long COVID

In February 2022, Virios announced a collaboration with the Bateman Horne Center (BHC) to test combination antiviral therapy for the treatment of Long COVID. Following an infection with SARS-CoV-2, the virus that causes COVID-19, approximately 30% of patients will experience symptoms that last for weeks or months, which is referred to as Long COVID. The range of symptoms varies from patient to patient, however the most commonly reported (from a recent meta analysis) were fatigue (58%), headache (44%), attention disorder (27%), hair loss (25%), and dyspnea (24%) (Lopez-Leon et al., 2021).

The main theories for what might be causing Long COVID include:

- The SARS-CoV-2 virus remains hidden in the body and continues to inflict damage

- An overreactive immune system set off by the SARS-CoV-2 virus remains at an elevated state, which may include the development of autoantibodies

- Immune suppression caused by the SARS-CoV-2 infection leads to the reactivation of a dormant virus

The planned trial with BHC will test the hypothesis that a dormant virus is being reactivated in Long COVID patients. This is a natural fit with what Virios is currently testing in patients with fibromyalgia (FM), in which the reactivation of the herpes simplex virus-1 (HSV-1) is hypothesized to be driving the disease. While Virios is testing IMC-1 (a combination therapy of famciclovir and celecoxib) in patients with FM, BHC will be testing IMC-2 (a combination of valacyclovir and celecoxib) in patients with Long COVID since it is their hypothesis that a herpesvirus (e.g., Epstein-Barr virus; EBV) could be to blame. BHC has chosen to test valacyclovir as part of the combination therapy since previous results suggest that valacyclovir is effective in reducing the number of EBV-infected B cells (Hoshino et al., 2009).

We anticipate the trial enrolling approximately 25-30 Long COVID patients with a control group to be comprised of a cohort of Long COVID patients treated by BHC with similar demographics. The study subjects will be treated for 14 weeks with a number of parameters being examined such as fatigue and brain fog. With an expected start in the second quarter of 2022, we anticipate topline data in the first half of 2023.

BHC is a non-profit, interdisciplinary Center of Excellence with a focus on treating myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), fibromyalgia (FM), post-viral syndromes, and related comorbidities, thus making them an excellent collaborator for Virios. While exploratory, this study expands Virios' pipeline and, with an estimated 373 million SARS-CoV-2 infections already being reported, represents an enormous potential opportunity should IMC-2 be effective.

Financial Update

On May 12, 2022, Virios announced financial results for the first quarter of 2022. As expected, the company did not report any revenues for the first quarter of 2022. R&D expenses for the three months ending March 31, 2022 were $2.8 million compared to $1.7 million for the first quarter of 2021. The increase was primarily due to increased expenses for clinical trials. G&A expenses for the first quarter of 2022 were $1.2 million compared to $1.4 million for the first quarter of 2021. The decrease was primarily due to a decrease in accounting and legal fees.

As of March 31, 2022, Virios had approximately $11.4 million in cash and cash equivalents. We estimate the company has sufficient capital to fund operations through the end of 2022. As of May 12, 2022, Virios had approximately 8.3 million common shares outstanding and, when factoring in stock options and warrants, a fully diluted share count of approximately 9.5 million.

Conclusion

With enrollment complete in the Phase 2b FORTRESS study, the countdown begins to the release of topline results, which we believe will occur in September 2022. The results of the chronic toxicology studies should be available at approximately the same time, thus Virios should be in position to approach the FDA about advancing IMC-1 into a Phase 3 program in fibromyalgia pending positive results from the FORTRESS study. With no changes to our model, our valuation remains at $22.

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