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Virios Therapeutics Announces Submission of Final Toxicology Results to Support Proposed Phase 3 Program for Novel Therapy to Treat Fibromyalgia
ATLANTA, May 15, 2023 (GLOBE NEWSWIRE) -- Virios Therapeutics, Inc. (Nasdaq: VIRI) (the “Company”), a development-stage biotechnology company focused on
About this update from Dogwood Therapeutics, Inc.
[{"type":"text","content":"ATLANTA, May 15, 2023 (GLOBE NEWSWIRE) -- Virios Therapeutics, Inc. (Nasdaq: VIRI) (the “Company”), a development-stage biotechnology company focused on advancing novel antiviral therapies to treat debilitating chronic diseases, including fibromyalgia (“FM”), today announced that it has submitted final toxicology reports as per Food & Drug Administration (“FDA”) request as part of their overall review of the Company’s Phase 3 proposal. Key Highlights Proposed Phase 3 program for lead development candidate IMC-1 to the FDA as treatment for FM consisting 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.Based on data from its 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. “We are pleased to report that we have submitted the final toxicology program results in support of our proposal to advance IMC-1 to Phase 3 development,” said Greg Duncan, Chairman and CEO of Virios Therapeutics. “We will report material FDA feedback on our Phase 3 proposal promptly, as we receive it.” About Virios Therapeutics Virios Therapeutics (Nasdaq: VIRI) is a development-stage biotechnology company focused on 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. Our 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. The Company is pursuing a second development candidate, a combination of valacyclovir and celecoxib, as a potential treatment for...