Business
Virios Therapeutics Announces Third Quarter 2022 Financial Results and Provides Corporate Update
- FORTRESS Study Analysis Reveals Fibromyalgia Patients New to Research Demonstrate Significant IMC-1 Pain Reduction Treatment Benefits - - Company Believes
About this update from Dogwood Therapeutics, Inc.
[{"type":"text","content":"\n- FORTRESS Study Analysis Reveals Fibromyalgia Patients New to Research Demonstrate Significant IMC-1 Pain Reduction Treatment Benefits -\n\n- Company Believes FORTRESS Safety Data Supports Phase 3 Development, Requesting FDA Meeting to Discuss Next Steps -\n\n- Patient Dosing Continues in IMC-2 Exploratory Long-COVID Treatment Study -\n\n- Conference Call Today at 8:30 a.m. ET -\n\n ATLANTA--(BUSINESS WIRE)--\nVirios Therapeutics, Inc. (Nasdaq: VIRI) (the “Company”), a development-stage biotechnology company focused on advancing novel, combination antiviral therapies to treat debilitating chronic diseases including fibromyalgia (“FM”), today announced financial results for the third quarter ended September 30, 2022, as well as plans to advance development of its lead antiviral development candidate, IMC-1, as a potential new treatment for FM patients.\n\nKey Highlights and Upcoming Milestones\n\n\nPost-hoc analysis of the FORTRESS (Fibromyalgia Outcome Research Trial Evaluating Synergistic Suppression of Herpes Simplex Virus-1) study results indicated that FM patients who were generally more naïve to prior clinical studies and prior FM drug treatment (“new” patients), demonstrated clinically and statistically significant reductions in pain, fatigue, FM symptoms and both anxiety and depression symptoms. In contrast, FM patients who were prior FM trial participants and/or study site database patients (“experienced” patients) did not exhibit a statistically significant treatment benefit in this study.\n\n\nThe Company believes targeting new FM patients for IMC-1 development is the optimal approach and plans to meet with the U.S. Food & Drug Administration (“FDA”) with the goal to progress IMC-1 into Phase 3 development.\n\n\nIn September, the Company raised $5 million in equity capital to further advance the clinical development of IMC-1 and for working capital and general corporate purposes.\n\n\nAs previously announced, Virios’ novel FM development candidate, IMC-1, demonstrated exemplary safety and tolerability in the FORTRESS study but did not achieve statistical significance on the pre-specified primary efficacy endpoint of change from baseline in daily self-reported average pain severity scores compared to placebo. However, analysis of the top-line data revealed a bifurcation of response based on the timing of patient enro...