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(Updated – September 19, 2022 7:15 am EDT)
Virios Therapeutics, Inc. (Nasdaq: VIRI), a development-stage biotechnology company focused on advancing novel combination antiviral therapies to treat debilitating chronic diseases, including fibromyalgia (“FM”), today announced topline results from its FORTRESS (Fibromyalgia Outcome Research Trial Evaluating Synergistic Suppression of Herpes Simplex Virus-1 (“HSV-1”)) study of oral IMC-1 for the treatment of FM.
Overall, the FORTRESS study failed to reach statistical significance at the pre-specified primary efficacy endpoint of change from baseline to week 14 in the weekly mean of daily self-reported mean pain severity scores comparing IMC-1 to placebo (p=0.302). However, analysis of the data suggests a bifurcation of responses based on the time of patient enrollment in the FORTRESS study. During the first half of the study (June 2021 to November 2021), IMC-1 showed no improvement over enrolled patients (n=208) when the delta variant of COVID-19 was the dominant strain in the US Placebo-treated patients. Conversely, in the second half of the study (November 2021 to April 2022) for those patients who enrolled (n=214) as vaccination rates improved and the less severe omicron variant of COVID-19 became the dominant US strain , IMC-1 treated patients demonstrated statistically significant improvement in the primary endpoint of pain reduction (p=0.03) at week 14, as well as statistically significant improvement in the key secondary PROMIS fatigue score (p=0.006) and the Fibromyalgia Impact Questionnaire-Revised ( FIQR) symptom domain score (p=0.015).
IMC-1 was well tolerated overall, with only 4.6% of IMC-1 treated patients discontinuing due to adverse events compared to 8.1% of placebo treated patients. No adverse event category in the IMC-1 group exceeded a 4% rate, with the exception of COVID-19 infection. Overall discontinuations were 18.5% in the IMC-1 treated group versus 23% in the placebo treated group. Patients in the FORTRESS study were randomized 1:1 to either IMC-1 or placebo, and patient demographics and baseline pain scores were well matched.
“We were surprised by the primary overall efficacy result of this study as we believe this approach has continued scientific validity and the potential to provide a much-needed, well-tolerated therapeutic option for FM patients. We believe that the interplay between different COVID-19 strains and herpesvirus activation may contribute to the differential response we observed in patients enrolled in 2021 versus 2022,” said Greg Duncan, Chairman and CEO of Virios Therapeutics. “Our team and external consultants are continuing to analyze the FORTRESS data and we will provide an update on our overall plan for the further development of IMC-1 as soon as possible.”
“Overall, the efficacy data from this study did not meet our expectations,” said R. Michael Gendreau, MD, Ph.D., Virios Therapeutics’ chief medical officer. “We will continue to investigate the potential of IMC-1 as a viable FM treatment option. We would like to thank all researchers and patients who participated in FORTRESS for their support of this important research.”
The FORTRESS study was a double-blind, placebo-controlled safety and efficacy study of combination antiviral therapy with IMC-1. The final enrollment included 425 patients aged 18 to 65 years, all of whom were diagnosed with FM using the 2016 American College of Rheumatology diagnostic criteria for FM. Study participants were matched 1-to-1 with either IMC-1 or a matched placebo. Three patients were randomized but no data were collected and are therefore excluded from our statistical analysis design. The pre-specified primary endpoint for the FORTRESS study was the reduction in pain over time, as measured by the change from baseline to endpoint at week 14 in the weekly average of daily self-reported average pain severity scores on the Numerical Rating Scale (“NRS”). of the diary. The values range from 0 to 10, with a higher value indicating a poorer result. Pain was recorded in an electronic diary system that patients used daily at home. In addition to assessing pain reduction in FM patients, the study also evaluated IMC-1’s ability to improve symptoms of fatigue and sleep disorders, and measured improvements in overall health and patient function.
The Virios Therapeutics team received open-label data from the FORTRESS study on Friday, September 16, 2022.
Virios Therapeutics will host a conference call and live webcast today, Monday, September 19 at 8:30 am Eastern Time to discuss the results of the FORTRESS study. The live webcast can be accessed at https://www.webcaster4.com/Webcast/Page/2639/46330. To participate in the conference call, US participants can call (888) 506-0062 and international participants can call (973) 528-0011. The conference ID number is 449989. A live webcast and replay of the conference will also be available on Virios Therapeutics, Inc.’s website at www.virios.com. A telephone replay of the conference call is available until Monday, October 3, 2022. To access this recording, US subscribers can call (877) 481-4010 and international subscribers can call (919) 882-2331. The replay conference ID number is 46330.