Virios Therapeutics, a biotechnology company focused on developing antiviral therapies for chronic diseases like fibromyalgia (FM) and Long-COVID, has received positive feedback from the Food & Drug Administration (FDA) regarding its IMC-1 safety study. The FDA confirmed that the chronic toxicology program conducted by the company appears sufficient to support the safety of IMC-1 at the proposed dose for chronic use.
With this critical feedback, Virios Therapeutics plans to initiate a pharmacokinetic and food effect study later this year. Simultaneously, the company will submit a final Phase 3 program outline and study protocols for FDA review. Following the completion of the pharmacokinetic study, expected by mid-2024, Virios Therapeutics aims to begin enrolling patients for the first Phase 3 study to evaluate the safety and efficacy of IMC-1 in treating fibromyalgia.
R. Michael Gendreau, the Chief Medical Officer of Virios Therapeutics, expressed excitement about the progress made. He highlighted how the safety and efficacy results from the FORTRESS trial, combined with the chronic toxicology program results, have allowed the company to define a clinical trial program and determine the optimal formulation and dose of IMC-1 to increase the chances of success.
Virios Therapeutics plans to share further information about its Phase 3 program for fibromyalgia during its earnings update on August 10, 2023.
Fibromyalgia is a chronic condition characterized by widespread pain, fatigue, and cognitive difficulties. The exact cause of the disease remains unclear, but an overactive immune response triggered by tissue-resident herpesvirus has been proposed as a possible root cause. The development candidates from Virios Therapeutics are fixed dose combinations of an antiviral compound and celecoxib, designed to synergistically suppress herpesvirus replication and alleviate virally promoted disease symptoms.
IMC-1, the lead development candidate consisting of famciclovir and celecoxib, has already been granted fast track designation by the FDA. Virios Therapeutics also plans to engage with the FDA in the second half of 2023 to evaluate IMC-2, a fixed combination of valacyclovir and celecoxib, as a potential treatment for the lingering effects of Long-COVID.
Since this news has significant implications for those suffering from fibromyalgia and Long-COVID, Virios Therapeutics aims to provide an effective treatment option to alleviate their symptoms. The company’s commitment to advancing novel antiviral therapies for these debilitating conditions brings hope to millions of individuals worldwide.
Disclaimer: This article contains forward-looking statements, subject to inherent uncertainties, risks, and assumptions. The statements made are based on Virios Therapeutics’ current expectations and may not prove to be accurate in the future. The company’s actual results may differ materially from these forward-looking statements. The article does not constitute financial or investment advice. Please consult with a professional investment advisor or conduct thorough research before making any investment decisions.
