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Virios Therapeutics Highlights Clinical Sites Fully Operational in Phase 2b Fibromyalgia Study Featuring FDA “Fast Track” Review Designated Antiviral Therapy, Oral IMC-1
ATLANTA--(BUSINESS WIRE)-- Virios Therapeutics, Inc. (Nasdaq: VIRI), a clinical-stage biotechnology company focused on advancing novel antiviral therapies to
About this update from Dogwood Therapeutics, Inc.
[{"type":"text","content":" ATLANTA--(BUSINESS WIRE)--\nVirios Therapeutics, Inc. (Nasdaq: VIRI), a clinical-stage biotechnology company focused on advancing novel antiviral therapies to treat chronic pain and fatigue related diseases, announced today that all 41 sites involved in its ongoing 460 patient Phase 2b fibromyalgia (FM) trial are now fully activated and enrolling patients. This trial builds on the encouraging results from the Company’s previously completed IMC-1 phase 2a FM clinical study. The 143-patient Phase 2a trial demonstrated that VIRI’s lead antiviral development candidate, orally administered IMC-1, met its primary endpoint of pain reduction and was statistically better tolerated than placebo.\n\nIMC-1 is a novel, proprietary, fixed dose, antiviral therapy combining famciclovir and celecoxib. This dual mechanism antiviral therapy is designed to synergistically suppress Herpes Simplex Virus-1 (“HSV-1”) activation and replication. It is the Company’s hypothesis that HSV-1 related immune responses can serve as a catalyst for symptoms commonly associated with FM, irritable bowel syndrome (IBS) and fatigue related disorders. This hypothesis is supported by both clinical and mechanistic data, the latter of which has suggested that HSV-1 is actively replicating in the tissue of patients diagnosed with FM and chronic GI disorders, such as IBS.\n\n“We are pleased that enrollment in our FORTRESS study is proceeding as planned and that all of our sites are now able to recruit patients,” said Dr. R. Michael Gendreau, Virios’ Chief Medical Officer.\n\nDr. Gendreau continued, “Data from our prior clinical work has been presented in several recent medical meetings. These data demonstrate that in our Phase 2a FM trial, in addition to meeting the primary endpoint of significantly greater pain reduction compared with placebo, patients treated with IMC‑1 reported significantly greater improvement on the Revised Fibromyalgia Impact Questionnaire (“FIQ-R”) total score showed significant improvement on all three of the FIQ‑R domains, and also showed statistical significance on the patient global impression of change (PGIC). In addition, treatment with IMC-1 was exceptionally well tolerated in this study. These secondary endpoint results, combined with excellent tolerability, suggest that IMC‑1 may represent a promising treatment option not only for alleviat...