Virios Fibromyalgia Drug Fails Phase IIb And Firm Says COVID-19 May Be To Blame

A Phase IIb trial testing IMC-1 for fibromyalgia failed to reach statistical significance on the primary pain endpoint, but one cohort showed an improvement and Virios intends to pursue the drug further.

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Virios saw different results in different cohorts in Phase IIb • Source: Shutterstock

Virios Therapeutics, Inc. thinks COVID-19 could have thwarted a Phase IIb trial testing its lead drug candidate, a fixed-dose combination of the antiviral famciclovir and non-steroidal anti-inflammatory celecoxib called IMC-1, for the treatment of fibromyalgia. The company, focused on antivirals for chronic diseases, announced on 19 September that the Phase IIb FORTRESS trial failed to demonstrate a statistically significant improvement in pain scores in patients with fibromyalgia versus placebo at week 14.

The results of the trial surprised management, coming after IMC-1 demonstrated efficacy on an array of fibromyalgia outcome measures in a Phase IIa clinical trial

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