Virios Therapeutics Long COVID Combo Therapy Shows Improvements: Long-COVID Impacts 65M People

Virios Therapeutics Inc VIRI announced that female patients diagnosed with Long-COVID illness exhibited clinically and statistically significant improvements related to Long-COVID when treated open-label with a combination of valacyclovir and celecoxib (Val/Cel) for 14 weeks, as compared to a control cohort. 

Prevalence estimates suggest that 65 million people worldwide suffer from Long-COVID sequelae.

The statistically significant improvements in Post-Acute Sequelae of COVID-19 infection (PASC) symptoms and general health status were encouraging, given that the mean duration of Long-COVID illness was two years for both the treated and control cohorts before enrollment in this trial.

The company plans to meet with the FDA in the second half of 2023 to discuss opening an investigational new drug application to formally assess the symptoms associated with PASC using a fixed dose combination of valacyclovir and celecoxib.

Treatment with Val/Cel was generally well tolerated, with an observed safety profile consistent with the known safety profiles of valacyclovir and celecoxib. 

No serious adverse events were observed in this study and only one treated patient discontinued treatment due to adverse events, possibly related to Val/Cel treatment. 

Price Action: VIRI shares are down 21.10% at $1.91 on the last check Monday.