Data on Phase 2a Secondary Efficacy Endpoints Presented at EULAR
On June 2, 2021, Virios Therapeutics, Inc. (NASDAQ:VIRI) announced a poster presentation at the annual EULAR European Congress of Rheumatology showing there was a significantly greater improvement on the Revised Fibromyalgia Impact Questionnaire (FIQ-R) total score and all three FIQ-R domains in patients taking IMC-1 compared to placebo. The FIQ-R contains 21 questions across three domains (function, overall impact, symptoms) and is a commonly used tool to assess functional capacity and the overall impact of FM on a patient’s life. The data is derived from the Phase 2a trial of IMC-1 in patients with fibromyalgia (FM). A copy of the poster presentation can be found here.
The following figure shows the mean change from baseline in the 24-hour recall average pain score recorded using the 11-point Numerical Rating Scale (NRS), which was the primary efficacy outcome of the Phase 2a trial, as well as the change from baseline in the FIQ-R 7-day recall scores. Both of those measures showed a statistically significant effect for those treated with IMC-1 compared to those treated with placebo.
When examining the different symptom domains of the FIQ-R, the following figure shows that treatment with IMC-1 resulted in a statistically significant improvement compared to placebo in the areas of stiffness, sleep quality, depression, and anxiety.
Lastly, the following table shows that a significantly greater percentage of IMC-1-treated patients met the criteria for response on the Patient Global Impression of Change (PGIC) compared to placebo-treated patients and there was a significantly greater improvement in PROMIS fatigue scores in IMC-1-treated patients compared to those treated with placebo. There was no statistically significant different in the change from baseline to 16 weeks in Multidimensional Fatigue Inventory (MFI).
The data presented at EULAR by Virios show that not only does IMC-1 have a significant impact on reducing pain in patients with FM but that it also significantly improves a number of other FM symptoms, including stiffness, sleep quality, depression, and anxiety. This is very encouraging and helps to reinforce our view that targeting HSV-1 infection could prove to be an effective means to treat FM. In addition, being able to positively impact multiple FM symptoms could lead to greater uptake by patients if the drug is approved. We look forward to the initiation of the Phase 2b clinical trial in the second quarter of 2021 and we anticipate topline results from the trial in the second quarter of 2022. With no changes to our model our valuation remains at $22 per share.
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