02.01.2024 13:40:37

Virios Therapeutics Reports Receipt Of FDA's Feedback On Requirements For Advancing IMC-2

(RTTNews) - Virios Therapeutics, Inc. (VIRI) announced receipt of the FDA feedback on requirements for advancing IMC-2, or a combination of valacyclovir + celecoxib, as a treatment for the fatigue, orthostatic intolerance and other symptoms associated with Long-COVID illness, also known as post-acute sequelae of SARS-CoV-2 infection. The FDA recommended assessment of a range of IMC-2 doses, including valacyclovir doses above presently approved dosage strengths. For the planned Phase 2 proof-of-concept study, the company can use fatigue as the primary endpoint and orthostatic intolerance as a key secondary endpoint to assess the effectiveness of IMC-2.

Following the receipt of the feedback, Virios is exploring options to advance the IMC-2 LC Phase 2 research program.

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