(RTTNews) - Virios Therapeutics, Inc. (VIRI), a development-stage biotechnology company focused on chronic diseases, including fibromyalgia or FM, Monday said topline results from its Phase 2b Study of oral IMC-1 for the treatment of FM failed to meet primary efficacy endpoint.
In pre market activity on Nasdaq, Virios shares were losing around 65.2 percent to trade at $$3.05.
The company noted that FORTRESS (Fibromyalgia Outcome Research Trial Evaluating Synergistic Suppression of Herpes Simplex Virus-1 or HSV-1) study was a double-blind, placebo-controlled safety and efficacy study of IMC-1 antiviral combination therapy.
The trial did not achieve statistical significance on the prespecified primary efficacy endpoint of change from baseline to Week 14 in the weekly average of daily self-reported average pain severity scores comparing IMC-1 to placebo.
However, analysis of the data suggests a bifurcation of response based on the timing of patient enrollment in the FORTRESS trial.
The company noted that IMC-1 was well-tolerated overall, with only 4.6% of IMC-1 treated patients dropping out due to adverse events, as compared with 8.1% of placebo treated patients.
Michael Gendreau, Chief Medical Officer of Virios, said, "Overall, the efficacy data from this trial were not what we had expected. We will continue to explore IMC-1's potential as a viable FM treatment option."
The company and outside advisors are in the process of further analyzing the FORTRESS data, and an update on its overall plan to advance the development of IMC-1 will be provided as soon as possible.
The Virios Therapeutics team received unblinded data relating to the FORTRESS study on September 16.
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