Virios Therapeutics Shares Tank After Failing Fibromyalgia Study

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  • Virios Therapeutics Inc's VIRI shares crashed after its FORTRESS Phase 2b trial of IMC-1 antiviral combination therapy for fibromyalgia failed to meet the primary endpoint.
  • Fibromyalgia is a disorder characterized by widespread musculoskeletal pain accompanied by fatigue, sleep, memory, and mood issues.
  • Overall, the FORTRESS study 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 pain severity scores comparing IMC-1 to placebo (p=0.302). 
  • However, data analysis suggests a bifurcation of response based on the timing of patient enrollment in the FORTRESS trial. 
  • During the first half of the trial, for the patients who were enrolled (n=208) when the Delta variant of COVID-19 was the dominant strain in the U.S., IMC-1 demonstrated no improvement versus placebo-treated patients. 
  • During the second half of the trial, for the patients who were enrolled (n=214) when vaccination rates improved and the less severe Omicron variant of COVID-19 became the dominant U.S. strain, IMC-1-treated patients demonstrated a statistically significant improvement in the primary pain reduction endpoint.
  • IMC-1 was well-tolerated overall, with 4.6% of IMC-1 treated patients dropping out due to adverse events, compared with 8.1% of placebo-treated patients.
  • Price Action: VIRI shares are down 64.10% at $3.15 on the last check Monday.
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