Virios Therapeutics to Develop Long Covid Therapy

Virios Therapeutics, Inc have announced plans for advancing IMC-2 (combination of valacyclovir and celecoxib) as a treatment for the fatigue, orthostatic intolerance and other symptoms associated with long covid, also known as post-acute sequelae of SARS-CoV-2 infection (“PASC”). The Company is targeting the initiation of a Phase 2 program in the second half of 2024, with data expected in 2025.

“We believe the profound unmet medical need associated with LC symptoms provides a unique and timely opportunity for Virios to advance our combination therapy, IMC-2,” said Greg Duncan, Chairman and CEO of Virios Therapeutics. “There are currently no FDA-approved LC treatments, thus IMC-2 has potential to be one of the first therapies for addressing LC symptoms. With FDA agreement that fatigue reduction can serve as the primary endpoint in this program, success on the LC indication may allow extension to other fatigue related illnesses such as Chronic Fatigue Syndrome, thereby expanding our potential market opportunity.”

“Virios has provided the Bateman Horne Centre with an unrestricted investigational grant to fund their ongoing placebo-controlled 12-week study of the valacyclovir/celecoxib combination in up to 60 LC patients, with data expected by mid-year 2024. In addition, we have received input from the FDA on development requirements and key endpoints associated with advancing IMC-2 into Phase 2 development as a treatment for LC symptoms. We are now taking the organisational steps necessary to prepare for the initiation of a Phase 2 clinical program in the second half of this year. We further expect to provide an update on potential partnership developments later this quarter,” Duncan concluded.