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Virios Therapeutics Announces Second Quarter 2023 Financial Results and Provides Corporate Update
- Continued Progress in Expanding and Advancing Clinical Pipeline -- Conference Call Today at 8:30 a.m. ET - ATLANTA, Aug. 10, 2023 (GLOBE NEWSWIRE) -- Virios
About this update from Dogwood Therapeutics, Inc.
[{"type":"text","content":"- Continued Progress in Expanding and Advancing Clinical Pipeline -- Conference Call Today at 8:30 a.m. ET - ATLANTA, Aug. 10, 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”) and Long-COVID, today announced financial results for the second quarter ended June 30, 2023 and provided a corporate update. Key Highlights and Upcoming Milestones The Company 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 treating fibromyalgia.The Company plans to initiate its proposed pharmacokinetic and food effect study (“pK”) this year, while concurrently submitting a final Phase 3 program outline and associated Phase 3 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.With the recent completion of the IMC-2 (fixed combination of valacyclovir and celecoxib) exploratory, open-label, Long-COVID proof of concept study conducted by the Bateman Horne Center, we are planning to sponsor a second investigator-initiated study with the Bateman Horne Center this fall. This follow up study will be a double-blinded placebo-controlled study otherwise very similar to the initial proof of concept study.The Company plans to meet with the FDA in the second half of 2023 to discuss a proposal to advance its IMC-2 into Phase 2 development as a potential treatment for the symptoms associated with Long-COVID illness. “We are encouraged about the potential to expand our pipeline and progress IMC-1 into Phase 3 development as a treatment for FM and IMC-2 into Phase 2 development as a treatment for Long-COVID. Our team is working closely with the FDA to determine next steps in advancing these promising programs,” said Greg Duncan, Chairman and CEO of Virios Therapeutics. Second Quarter 2023 Financial Results Research and development expenses for the second quarter of 2023 were $0.6 million, compared to $2.4 million for the second quarter of 2...