VIRI - Virios says mid-stage pain trial for lead asset did not reach main goal

Clinical-stage biotech Virios Therapeutics, Inc. ( NASDAQ: VIRI ) announced Monday that the company’s lead candidate, IMC-1, did not achieve statistical significance for the main goal in its Phase 2b trial involving patients with fibromyalgia.

The FORTRESS study, designed to evaluate oral IMC-1 antiviral therapy against placebo, enrolled 425 female fibromyalgia patients aged 18 to 65.

A candidate with the FDA’s fast track designation, IMC-1 is a combination therapy consisting of famciclovir and celecoxib designed to suppress herpes virus replication to reduce virally driven disease symptoms.

The trial did not reach statistical significance for the primary efficacy endpoint of change in the weekly average of daily average pain severity scores, as reported by patients from baseline to Week 14 (p=0.302).

However, during the second half of the trial, when the less severe Omicron variant became dominant in the U.S., the patients who joined the study (n=214) indicated a statistically significant improvement on the primary pain reduction endpoint (p=0.03) at week 14.

During the first half, when the Delta variant was dominant, IMC-1 indicated no improvement versus placebo.

“We believe the interplay between different COVID-19 strains and herpes virus activation may be contributing to the differential response we observed in patients enrolled in 2021 versus 2022,” VIRI Chief Executive Greg Duncan said.

Overall discontinuations in the trial stood at 18.5% and 23% in the IMC-1 and placebo arms, respectively.

The company said that further analysis of FORTRESS data is currently underway, and an update on the future development plans for IMC-1 is expected shortly.

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