Virios, FDA AGree FDA on Advancing Development Candidate IMC-2 to Treat Long-COVID

Virios Therapeutics, Inc. (Nasdaq: VIRI) (the “Company”), a development-stage biotechnology company focused on developing novel antiviral therapies to treat debilitating chronic diseases, including fibromyalgia (“FM”) and Long-COVID (“LC”), today 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.

https://www.globenewswire.com/news-release/2024/01/02/2802578/0/en/Virios-Therapeutics-Inc-Reaches-Alignment-with-FDA-on-Requirements-for-Advancing-Development-Candidate-IMC-2-as-Treatment-for-Long-COVID.html