hVIVO, a specialty biopharma company, has revealed positive results for the primary endpoint, following completion of analysis of samples by the National Institute of Allergy and Infectious Diseases (NIAID) and additional results from the Phase IIb viral challenge study of FLU-v, (Study 004, NCT03180801), it was reported on Friday.
FLU-v is being developed by Imutex, the company's 49% joint venture with the SEEK Group.
Following additional analysis of the samples from the study by NIAID, part of the US National Institutes of Health, the company reports that the study's primary endpoint achieved a statistically significant result. One dose of FLU-v produced a highly statistically significant decrease in the primary endpoint of Mild to Moderate Influenza Disease, 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 National Institute of Allergy and Infectious Diseases 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.
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