Virios Therapeutics, Inc. announced receipt of the Food and Drug Administration's ("FDA") feedback on requirements for advancing IMC-2 (combination of valacyclovir + celecoxib) as a treatment for the fatigue, orthostatic intolerance and other symptoms associated with LC illness, also known as post-acute sequelae of SARS-CoV-2 infection ("PASC"). Key Highlights Associated with FDA Feedback: The FDA agreed that for the planned Phase 2 proof-of-concept study, Virios can use fatigue as the primary endpoint and orthostatic intolerance as a key secondary endpoint to assess the effectiveness of IMC-2 in treating PASC. The FDA recommended assessment of a range of IMC-2 doses, including valacyclovir doses above presently approved dosage strengths, to ensure effective inhibition of reactivated herpesvirus.

Following the receipt of the FDA's feedback, Virios is currently exploring options to advance the IMC-2 LC Phase 2 research program. IMC-2 has the potential to be one of the first approved treatments specifically for LC.