Zacks Small Cap Research – VIRI: Moving IMC-2 into Phase 2 Program in Long COVID – Technologist

By David Bautz, PhD

NASDAQ:VIRI

READ THE FULL VIRI RESEARCH REPORT

Business Update

IMC-2 to be Developed as Treatment for Long COVID

In January 2024, Virios Therapeutics, Inc. (NASDAQ:VIRI) announced alignment with the U.S. Food and Drug Administration (FDA) on the requirements for advancing IMC-2 (valacyclovir + celecoxib) as a treatment for Long COVID as well as the company’s intention to initiate a Phase 2 program in Long COVID in the second half of 2024. 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. Based on the feedback from the FDA, Virios is planning to initiate a Phase 2 program in Long COVID for IMC-2 in the second half of 2024, with data anticipated in the second half of 2025.

Final details regarding the Phase 2 trial of IMC-2 in Long COVID will depend upon the results of an ongoing Phase 2 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

Data from this study are anticipated in mid-2024. 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).

Conclusion

Virios has a clear pathway to initiate a Phase 2 program for IMC-2 in Long COVID in the second half of 2024. The company is continuing to have partnering discussions but is prepared to advance IMC-2 ahead on its own. The final details of the Phase 2 trial won’t be known until the company has a chance to review the results of the ongoing Phase 2 trial of IMC-2 at the Bateman Horne Center in Long COVID patients. Those results should be available in mid-2024. We also anticipate an update from the company on partnering discussions for IMC-1 in fibromyalgia at some point in the near future. We have advanced our DCF model ahead by one year, which has increased our valuation to $4.00 per share.

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