Virios Therapeutics, Inc. announced that female patients diagnosed with Long-COVID illness, otherwise known as Post-Acute Sequelae of COVID-19 infection (?PASC?), exhibited clinically and statistically significant improvements in fatigue, pain, and symptoms of autonomic dysfunction and general well-being 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 of female Long-COVID patients matched by age, gender and length of illness and treated with routine care. The statistically significant improvements in PASC symptoms and general health status were particularly encouraging given that the mean duration of Long-COVID illness was two years for both the treated and control cohort prior to enrollment in this trial. This open-label, single-center, investigator-initiated study was conducted at the Bateman Horne Center (?BHC?) with an unrestricted investigational grant.

BHC is a non-profit, interdisciplinary Center of Excellence advancing the diagnosis and treatment of chronic fatigue disorders including myalgic encephalomyelitis/chronic fatigue syndrome (?ME/CFS?), FM, post-viral syndromes, and related comorbidities. Based on these data, the Company plans to meet with the Food and Drug Administration (?FDA?) in the second half of 2023 to discuss opening an investigational new drug application to formally assess treatment of symptoms associated with PASC using a fixed dose combination of valacyclovir and celecoxib. Prevalence estimates suggest as many as 65 million people worldwide suffer Long-COVID sequelae, including varying degrees of fatigue, cognitive problems, headache, sleep disruption, myalgias, arthralgias, post-exertional malaise and autonomic dysfunction/orthostatic intolerance.