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NASDAQ:VIRI
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Financial Update
On September 23, 2022, Virios Therapeutics, Inc. (NASDAQ:VIRI) announced the closing of a previously announced underwritten public offering of 10 million shares of common stock at a price of $0.50 per share. The company raised gross proceeds of $5.0 million before deducting underwriting discounts, commissions, and offering expenses. We estimate the company now has sufficient capital to fund operations into the second quarter of 2023, however the company will need to raise additional capital for any potential future trials of IMC-1 in fibromyalgia.
Business Update
FORTRESS Trial Does Not Meet Primary Endpoint
On September 19, 2022, Virios Therapeutics, Inc. (VIRI) announced topline results from the Phase 2b FORTRESS (Fibromyalgia Outcome Research Trial Evaluating Synergistic Suppression of Herpes Simplex Virus-1) trial of IMC-1 for the treatment of fibromyalgia (FM). The FORTRESS trial was a randomized double blind, placebo controlled study of IMC-1. The primary endpoint of the trial was reduction in pain and secondary endpoints included change in fatigue, sleep disturbance, global health status, and patient functionality (NCT04748705). A copy of the company’s data presentation can be found here.
The topline results showed that the FORTRESS trial did not achieve statistical significance on the prespecified primary efficacy endpoint of change from baseline to Week 14 in the weekly average of daily self-reported average pain severity scores comparing IMC-1 to placebo (P=0.302). The following graph shows the primary endpoint over the 16 weeks of the trial (all participants received placebo after Week 14). Patients receiving IMC-1 showed a statistically significant treatment effect over the first five weeks of the trial, however that separation diminished between the two treatment groups and by Week 14 there was no statistically significant difference.
A similar lack of separation between the two treatment groups was seen in the secondary endpoints examining the PROMIS Fatigue outcome as well as the FIQR Symptom Domain and the FIQR Function Domain, as shown in the following graphs.
The company performed an initial deeper examination of the data by separating out patients that were enrolled in the first half of the trial (“Cohort 1”) compared to patients that were enrolled in the second half of the trial (“Cohort 2”). It was noted that during the first half of the trial the Delta variant of SARS-CoV-2 was the predominant strain circulating in the U.S. while during the second half of the trial the Omicron strain was dominant. While the differing SARS-CoV-2 strains may not have impacted the FORTRESS trial, it is interesting that there seems to be a large difference in the efficacy outcomes for the two cohorts.