Virios Therapeutics Receives FDA Feedback on Proposed Phase 3 Program; Share Price up 87%
Virios Therapeutics (Nasdaq: VIRI) has received initial feedback from the FDA regarding its proposed Phase 3 program for IMC-1, a potential treatment for fibromyalgia.
IMC-1 is a novel, proprietary, fixed dose combination of famciclovir and celecoxib designed to synergistically suppress herpes virus replication, to reduce virally-promoted fibromyalgia disease symptoms. It has been granted fast track designation by the FDA.
The company’s share price increased by 87% following the news.
Highlights
The FDA has provided initial feedback to Virios, stating that the company’s Phase 3 proposal is acceptable, subject to review of the final results from its recently completed chronic toxicology program.
Virios expects to submit final toxicology reports and associated data to the FDA in May 2023.
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 (famciclovir and celecoxib) as separate comparator arms, a long-term safety trial, and a pharmacokinetic/food effect study.
Virios has stated that its goal is to advance IMC-1 into Phase 3 development as a potential new treatment option for the FM patient community.
About Virios Therapeutics
Virios Therapeutics is advancing novel antiviral therapies to treat debilitating chronic diseases, such as fibromyalgia (FM). Immune responses related to the activation of tissue resident herpes have been postulated as a potential root cause triggering and/or sustaining chronic illnesses such as FM, irritable bowel disease, chronic fatigue syndrome and other functional somatic syndromes, all of which are characterized by waxing and waning symptoms with no obvious etiology. The company’s lead development candidate (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 disease symptoms. IMC-1 has been granted fast track designation by the FDA.
