Virios Therapeutics Inc’sVIRI 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.
