Zacks Small Cap Research – VIRI: Enrollment Complete in Phase 2a Long COVID Trial; Results Expected in October 2024… – Technologist

By David Bautz, PhD

NASDAQ:VIRI

READ THE FULL VIRI RESEARCH REPORT

Business Update

Phase 2a Trial Results of IMC-2 in Long COVID Expected in October 2024

Virios Therapeutics, Inc. (NASDAQ:VIRI) is advancing IMC-2 (valacyclovir + celecoxib) as a treatment for Long COVID. The drug is currently being evaluated in a Phase 2a clinical trial being conducted by the Bateman Horne Center. Virios previously supplied the Bateman Horne Center with an unrestricted investigational grant to fund the ongoing 12-week, placebo controlled study of the valacyclovir/celecoxib combination in up to 60 Long COVID patients across three treatment arms:

• Val/Cel 750mg/200mg BID (1.5g/400mg per day)

• Val/Cel 1500mg/200mg BID (3.0g/400mg per day)

• Placebo

The company announced that enrollment of the Phase 2a trial had completed in July 2024 and that data from this study are anticipated in October 2024. Previously, the company announced it had reached alignment with the U.S. Food and Drug Administration (FDA) on the requirements for advancing IMC-2 as a treatment for Long COVID. The FDA agreed that for the Phase 2 study, Virios can use fatigue as the primary endpoint and orthostatic intolerance as a key secondary endpoint. In addition, the FDA would like Virios to evaluate a range of IMC-2 doses, which includes valacyclovir doses above presently approved dosage strengths.

Previously, the Bateman Horne Center conducted an open label, proof-of-concept trial of IMC-2 in patients with Long COVID and showed that patients experienced clinically and statistically significant improvements in fatigue, pain, and symptoms of autonomic dysfunction. Importantly, the combination of valacyclovir/celecoxib was well tolerated as there were no serious adverse events and the side effect profile was consistent with what is known for both valacyclovir and celecoxib. The following table gives an overview of the results for various study endpoints examined, the majority of which statistically significantly favored valacyclovir/celecoxib. For a full analysis of those results please see our previous report here.

While we believe the treatment of Long COVID is a compelling opportunity, it is difficult to get an accurate assessment of the total number of individuals who are suffering from the condition. A 2023 survey by the Centers for Disease Control (CDC) estimated that the prevalence of Long COVID in U.S. adults went from 7.5% in 2022 to 6.0% in 2023, but remained unchanged during 2023 (Ford et al., 2023). Importantly, approximately one-quarter of adults in that survey reported significant activity limitations due to Long COVID. This is translating into a severe economic cost, including an estimated approximately $500 billion in increased medical expenses (Cutler, 2022). A recent study in the New England Journal of Medicine shows that Long COVID continues to be a pressing unmet medical need, particularly among unvaccinated individuals (Xie et al., 2024).

Financial Update

On August 8, 2024, Virios announced financial results for the second quarter of 2024. As expected, the company did not report any revenues for the second quarter of 2024. R&D expenses for the three months ending June 30, 2024 were $0.3 million compared to $0.6 million for the second quarter of 2023. The decrease was primarily due to decreased expenses for drug development and manufacturing. G&A expenses for the second quarter of 2024 were $0.7 million compared to $0.9 million for the second quarter of 2023. The decrease was primarily due to a decrease in insurance expenses and accounting and legal fees.

As of June 30, 2024, Virios had approximately $3.0 million in cash and cash equivalents due in part to a public financing in May 2024 in which the company raised gross proceeds of $1.7 million. We estimate the company has sufficient capital to fund operations into the first quarter of 2025. As of August 7, 2024, Virios had approximately 27.8 million common shares outstanding and, when factoring in stock options and warrants, a fully diluted share count of approximately 30.3 million.

Conclusion

We look forward to the results of the ongoing Phase 2 clinical trial of IMC-2 in Long COVID in October 2024. These results will help to guide the design of a Phase 2b trial, and while the final details of the trial won’t be known until closer to its initiation, it’s good to see that the FDA has agreed to the use of fatigue as the primary endpoint. We also anticipate an update from the company on partnering discussions for IMC-1 in fibromyalgia at some point in the near future. After incorporating the recent financing into our model our valuation is now $3.00 per share.

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