Virios Therapeutics, Inc. announced that the Food & Drug Administration ("FDA") communicated that, following their initial review of the Company's chronic toxicology program, the program's studies appear adequate to support the safety of IMC-1 at the dose proposed by the Company for chronic use. With this critical feedback in hand, the Company plans to initiate its proposed pharmacokinetic and food effect study ("pK") this year, while concurrently resubmitting a final Phase 3 program outline and study protocols for FDA review. Following completion of the pK study, the goal will be to begin enrollment in the first fibromyalgia Phase 3 safety and efficacy study in mid-2024.

The Compapany plans to execute the pK study in males and females as a precursor to the FM studies with an updated IMC-1 dose and formulation, which is intended to enable the Company to take advantage of all of the efficiencies afforded with utilization of the 505(b)(2) regulatory pathway. Consistent with the previously proposed Phase 3 plan, the Company will currently submit its final Phase 3 program outline and associated study protocols to FDA, to progress the following: Two adequate and well-controlled clinical studies; and A long-term extension trial to support chronic administration of IMC-1. Based on the results from its recently completed FORTRESS Phase 2b trial, the Company has designed a Phase 3 development program targeting community-based FM patients who have not participated in prior FM trials. The safety and efficacy results from the FORTRESS trial, along with the chronic toxicology program results, have enabled to define a clinical trial program as well as a formulation and dose of IMC-1 to enhance chances for success.

The Company will share more information about its FM Phase 3 program during its earnings update on August 10, 2023 at 8:30 a.m. ET.