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Virios Therapeutics Announces First Quarter 2023 Financial Results
ATLANTA, May 11, 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 11, 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 financial results for the first quarter ended March 31, 2023. Key Highlights The Company proposed a Phase 3 program for its lead development candidate IMC-1 to the U.S. Food & Drug Administration (“FDA”) as a 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 preceding 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.Initial FDA feedback was that the agency is amenable to the Company’s Phase 3 proposal, subject to review of the final results from its recently completed chronic toxicology program. The Company submitted final toxicology reports as per FDA’s request as part of their overall review of the Phase 3 proposal in May 2023.An updated IMC-1 Phase 3 program proposal, responsive to FDA guidance, will also be provided once FDA completes its review of the chronic toxicology reports.Top line results from the exploratory Long-COVID study, featuring the combination of valacyclovir and celecoxib to treat Long-COVID sequelae, are expected in June 2023. “Our initial discussions with the FDA regarding our fibromyalgia program were constructive and we look forward to further FDA feedback on our proposal to advance IMC-1 to Phase 3 development,” said Greg Duncan, Chairman and CEO of Virios Therapeutics. First Quarter 2023 Financial Results Research and development expenses for the first quarter of 2023 were $0.5 million, compared to $2.8 million for the first quarter of 2022. The quarter over quarter change was due to decreases in expenses for clinical trials of $2.2 million, toxicology studies of $0.1 million and salaries and related costs of $0.1 million, offset by an increase in regulatory consulting costs of $0.1 million. General and administr...