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Virios Therapeutics Achieves Over 50% Enrollment Milestone in its Phase 2b Clinical Trial for Fibromyalgia
New Potential Treatment Targets Millions of Fibromyalgia Patients Worldwide First Ever FDA “Fast Track” Designation for Fibromyalgia Development Candidate
About this update from Dogwood Therapeutics, Inc.
[{"type":"text","content":"\n\nNew Potential Treatment Targets Millions of Fibromyalgia Patients Worldwide\n\n\nFirst Ever FDA “Fast Track” Designation for Fibromyalgia Development Candidate\n\n\nPhase 2b Clinical Trial Builds on Positive Phase 2a Data\n\n\n ATLANTA--(BUSINESS WIRE)--\nVirios Therapeutics, Inc. (Nasdaq: VIRI), a development-stage biotechnology company focused on advancing novel antiviral therapies to treat debilitating chronic diseases, including fibromyalgia, announced today that more than 50% of the patients planned for the Phase 2b FORTRESS (Fibromyalgia Outcome Research Trial Evaluating Synergistic Suppression of HSV-1) study have been randomized.\n\nThe FORTRESS study is a randomized, double-blind evaluation of IMC-1 in patients with fibromyalgia (“FM”). Worldwide, FM affects 3-6% of the population and is characterized by widespread chronic pain and multiple symptoms often including severe fatigue, sleep disruption and cognitive dysfunction. Based on Virios market analysis, we estimate that only 15% of FM treatment prescribers report satisfaction with existing treatment options. The FORTRESS study builds on the statistically significant results from the Company’s previously completed Phase 2a FM clinical study. The 143-patient Phase 2a trial demonstrated that IMC-1 met its primary endpoint of pain reduction and was statistically better tolerated than placebo.\n\n“We are pleased that enrollment in our FORTRESS trial is progressing rapidly, with careful patient selection and the support of more than 40 U.S. clinical sites,” said R. Michael Gendreau, M.D., Ph.D., Chief Medical Officer of Virios Therapeutics. “We are very grateful for the physicians at these sites and their patients for their commitment and willingness to participate in this critical FM trial, especially during a pandemic. Reaching this enrollment milestone on a timely basis indicates that we are currently on track to report top line results in Q3 of 2022.”\n\nGreg Duncan, Chairman and CEO of Virios, stated, “Fibromyalgia is a chronic disease that affects 10 million patients in the U.S. As many as 40% of FM patients are being treated with opioids, according to market surveys. This is particularly troubling given FM patients treated with opioids have been shown to experience worse outcomes among multiple assessment domains. Consistent with our mission, Virios Therapeutics...