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Virios Therapeutics Completes Enrollment of 425 Patients in Phase 2b “FORTRESS” Clinical Trial for Fibromyalgia
- Top line Data from the FORTRESS Study Expected in September 2022 - ATLANTA--(BUSINESS WIRE)-- Virios Therapeutics, Inc. (Nasdaq: VIRI), a development-stage
About this update from Dogwood Therapeutics, Inc.
[{"type":"text","content":"\n- Top line Data from the FORTRESS Study Expected in September 2022 -\n\n ATLANTA--(BUSINESS WIRE)--\nVirios Therapeutics, Inc. (Nasdaq: VIRI), a development-stage biotechnology company focused on advancing novel, combination antiviral therapies to treat debilitating chronic diseases, including fibromyalgia, announced today that it has completed enrollment in its Phase 2b FORTRESS (Fibromyalgia Outcome Research Trial Evaluating Synergistic Suppression of Herpes Simplex Virus-1 (“HSV-1”)) study, which is a randomized, double-blind evaluation of IMC-1 in patients with fibromyalgia (“FM”).\n\nVirios’ lead antiviral development candidate, orally administered IMC-1, is a novel, proprietary, fixed dose, antiviral therapy combining famciclovir and celecoxib. This dual mechanism antiviral therapy is designed to synergistically suppress herpes virus activation and replication.\n\n“As an innovative new approach to the treatment of fibromyalgia, the potential for IMC-1 to address patients’ symptoms with minimal side effects has motivated investigators, and most importantly patients, to participate in our study, despite the COVID-19 pandemic environment,” said R. Michael Gendreau, M.D., Ph.D., Chief Medical Officer of Virios Therapeutics. “Based on the high level of interest in our study and the diligent efforts of the trial sites and our clinical operations team, we completed enrollment on plan and expect to report top line results in September 2022.”\n\nGreg Duncan, Chairman and CEO of Virios, stated, “At Virios we believe that activated herpes virus may serve as a potential catalyst for triggering or maintaining diseases like FM. Targeting suppression of herpes virus with combination therapy represents the potential for an exciting new treatment paradigm for FM. Our novel antiviral combination could be a “game changer” for millions of patients suffering from FM, especially given that our market research indicates that only 15% of surveyed physicians treating FM patients report satisfaction with existing treatment options.”\n\nIMC-1 has received “fast track” designation by the U.S. Food and Drug Administration (“FDA”), the first of its kind for a new FM development candidate. The FORTRESS study builds on the statistically significant results from the Company’s previously completed Phase 2a FM clinical study. The previous 143-patient tria...