VIRI - Virios surges 48% on positive feedback from FDA on fibromyalgia disease treatment

2023-04-24 16:51:29 ET

• Virios Therapeutics ( NASDAQ: VIRI ) is trading 48% higher post market after it received initial feedback from the U.S. Food & Drug Administration (“FDA”) on its Phase 3 FM program proposal featuring its lead development candidate IMC-1.
• Virios’ IMC-1 Phase 3 Proposed Program is considered acceptable by the FDA, the company said.
• IMC-1 is a fixed dose combination of famciclovir and celecoxib designed to suppress herpes virus replication, with the end goal of reducing virally promoted fibromyalgia disease symptoms
• Within the proposed Phase 3 program, there are four key components, consisting of two adequate and well-controlled clinical studies. One of these is a full factorial study, with IMC-1 components famciclovir and celecoxib operating as separate comparator limbs, along with a long-term safety study and a pharmacokinetic/food effect exploration.
• The Company will submit the final toxicology reports and associated data in May 2023.
• Press Release

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