Positive results from FLU-v study welcomed by hVIVO

Clinical development services company hVIVO announced positive results 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.

The AIM-traded firm said FLU-v was being developed by Imutex, its 49%-owned joint venture with the SEEK Group.

It said that, following additional analysis of the samples from the study by the National Institute of Allergy and Infectious Diseases (NIAID) - part of the US National Institutes of Health - the study's primary endpoint achieved a “statistically significant” result.

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.

It explained that a statistically significant additional endpoint had been achieved from further data analysed by the NIAID from FLU-v 004, which confirmed the result for the primary endpoint, and ahd the potential to become the primary regulatory endpoint for Phase III.

hVIVO said the results, together with the previously-reported highly statistically significant reduction in symptoms endpoint and performing better than placebo in a number of other key endpoints, was evidence of the vaccine's protective effect.

“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,” said hVIVO executive chairman Trevor Phillips.

“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.”

Phillips said the final results were further verification that FLU-v was achieving measures of clinical efficacy, and was now positioned to enter Phase III.

He said the successful achievement of statistical significance in the primary endpoints from two Phase II studies confirmed that FLU-v had clinical impact in establishing immunity and disease, symptom and viral load reduction.

“The exploratory design of -004 has also enabled us to determine, what we believe to be the most appropriate clinical efficacy endpoint, relating to confirmed influenza infection, for application in the Phase III programme and we look forward to discussing this with the regulatory authorities at our next meetings.”

“We continue to endeavour to progress strategic discussions with regards to our joint venture, Imutex, and to maximise the strategic options available to both companies as we now await publication of the data from the UNISEC and NIAID FLU-v studies in peer reviewed journals.”