Virios jumps 23% after FDA feedback on proposed IMC-1 program for FM treatment

Virios Therapeutics jumps 23% or 14c per share to to 77c in late-day trading after announcing a program summary based on initial feedback from the U.S. Food & Drug Administration on its Phase 3 FM program proposal featuring its lead development candidate IMC-1. IMC-1 is a novel, proprietary, fixed dose combination of famciclovir and celecoxib designed to synergistically suppress herpes virus replication, with the end goal of reducing virally promoted fibromyalgia disease symptoms. This feedback was provided following a guidance meeting between the Anesthesiology, Addiction Medicine and Pain Medicine division of FDA and the Company in The proposed Phase 3 program consists of four primary components: two adequate and well-controlled clinical studies, one of which would be a full factorial design with each of the individual components of IMC-1 as separate comparator arms, a long-term safety trial, and a pharmacokinetic/food effect study. Based on data from the recently completed FORTRESS Phase 2b trial, the Company proposed a Phase 3 development program targeting community-based FM patients, who have not participated in prior FM trials. Initial FDA feedback was that the Company’s Phase 3 proposal is acceptable, subject to review of the final results from its recently completed chronic toxicology program. The Company will submit the final toxicology reports and associated data in May 2023.