HVO Jan 201915 Dec 2020 11:42
hVIVO plc (AIM: HVO), an industry leading clinical development services business pioneering human disease models based upon viral and allergen challenge, today announces positive result for the primary endpoint, following completion of analysis of samples by NIAID and additional results from the Phase IIb viral challenge study of FLU-v, (Study 004, NCT03180801). FLU-v is being developed by Imutex Limited, hVIVO's 49% joint venture with the SEEK Group.
· Following additional analysis of the samples from the study by the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health, hVIVO reports that the study's primary endpoint achieved a statistically significant result
o One dose of FLU-v produced a highly statistically significant reduction in the primary endpoint of Mild to Moderate Influenza Disease (MMID), comprising a positive signal of influenza infection and at least one influenza symptom, compared with placebo (p=0.035)
· A statistically significant additional endpoint has been achieved (p=0.006) from further data analysed by the NIAID from FLU-v 004, which confirmed the result for the primary endpoint and has the potential to become the primary regulatory endpoint for Phase III
· These results together with the previously reported highly statistically significant reduction in symptoms endpoint (p=0.023) and performing better than placebo in a number of other key endpoints is evidence of the vaccine's protective effect
Trevor Phillips, Executive Chairman of hVIVO, said: "We are pleased to finally be in a position to report a positive primary endpoint outcome for this Phase IIb challenge study resulting from the NIAID's additional analysis of samples taken during the study. These results follow an announcement in March 2018 confirming that key secondary endpoints in symptom reduction had achieved statistical significance and indicating that the NIAID would be conducting further sample analyses to assess the primary endpoint outcome, as the initial analysis, using results from a less sensitive assay for the presence of influenza virus, had showed the primary endpoint only trended to statistical significance. The more sensitive assay, routinely utilised by NIAID to assess the presence of virus, identified more cases of influenza infection than had originally been determined, resulting in the achievement of statistical significance. These final results are further verification that FLU-v is achieving measures of clinical efficacy and is now positioned to enter Phase III.
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