- Virios Therapeutics Inc VIRI announced a program summary based on initial feedback from the FDA 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, aiming to reduce virally promoted fibromyalgia (FM) disease symptoms.
- The proposed Phase 3 program consists of four primary components: Two adequate and well-controlled clinical studies, 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.
- FORTRESS Phase 2b trial of IMC-1 antiviral combination therapy for fibromyalgia failed to meet the primary endpoint.
- 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.
- An updated IMC-1 Phase 3 program proposal, responsive to FDA guidance, will also be provided once the FDA reviews the chronic toxicology reports.
- The company will provide material progress updates as it continues to work with the FDA to advance IMC-1 into Phase 3 development as a potential new treatment option for the FM patient community.
- Price Action: VIRI shares are up 87.1% at $1.17 on the last check Tuesday.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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