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Virios Therapeutics Announces Scheduling of FDA Meeting in March 2023 to Discuss IMC-1 Fibromyalgia Phase 3 Program
ATLANTA, Jan. 05, 2023 (GLOBE NEWSWIRE) -- Virios Therapeutics, Inc. (Nasdaq: VIRI), a development-stage biotechnology company focused on advancing novel,
About this update from Dogwood Therapeutics, Inc.
[{"type":"text","content":"ATLANTA, Jan. 05, 2023 (GLOBE NEWSWIRE) -- Virios Therapeutics, Inc. (Nasdaq: VIRI), a development-stage biotechnology company focused on advancing novel, combination antiviral therapies to treat debilitating chronic diseases including fibromyalgia (“FM”), announced today that its end-of-Phase 2 meeting request with the U.S. Food and Drug Administration (“FDA”) to discuss advancing IMC-1 into Phase 3 development as a treatment for FM has been scheduled for mid-March 2023. At this meeting, the Company will discuss with the FDA plans for a Phase 3 program that would support submission of a new drug application for IMC-1 for the treatment of FM. The Company plans to provide a program update by the end of April following the receipt of formal written feedback from the FDA. The Company believes the safety and efficacy results from its FORTRESS Phase 2b FM study support progression of IMC-1 to Phase 3 development for “new” patients, who represent the vast majority of the FM patient community. Analysis of the Company’s recent FORTRESS Phase 2b FM study data revealed: “New” FM patients treated with its novel FM development candidate, IMC-1 , who were recruited into FORTRESS via advertising, demonstrated statistically significant reductions in FM related pain, fatigue, anxiety and depressive symptoms and showed an overall improvement in their global health status.In contrast, “experienced” FM patients (i.e. patients previously enrolled in FM studies and those with a prior relationship with the FORTRESS study sites), who in the Company’s view represent a more treatment refractory/resistant cohort of patients, did not exhibit meaningful treatment benefits.“New” patients treated with IMC-1 also exhibited a lower discontinuation rate due to adverse events as compared with “new” patients receiving] placebo.All patients treated with IMC-1 demonstrated exemplary safety and tolerability in the FORTRESS study. About Virios Therapeutics Virios Therapeutics (Nasdaq: VIRI) is a development-stage biotechnology company focused on advancing novel antiviral therapies to treat debilitating chronic diseases, such as fibromyalgia (“FM”). Immune responses related to the activation of tissue resident herpes have been postulated as a potential root cause triggering and/or sustaining chronic illnesses such as FM, irritable bowel disease, chronic fatigue syndro...