HVIVO reports that the Phase IIb viral challenge Study for FLU-v (FLU-v004) achieved the primary endpoint of a statistically significant reduction in Mild to Moderate Influenza
Update to results announced 26 March 2018
Completes a compelling Phase II FLU-v data package around this first-in-class ‘universal’, broad spectrum, standalone, influenza vaccine candidate
- Primary endpoint achieved
- Additional endpoint achieved statistical significance and is identified as potential primary endpoint for future Phase III trials
London, UK 10 January 2019: 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. The successful achievement of statistical significance in the primary endpoints from two Phase II studies confirms that FLU-v has 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.”
Gregory Stoloff, Chief Executive Officer of SEEK, said: “NIAID has been conducting further and a more sensitive viral detection analysis on the FLU-v challenge study results as previously communicated. Our FLU-v vaccine has now demonstrated in two different Phase IIb studies, a statistically enhanced immune response which has translated into a statistical reduction in the number of people getting sick and severity of influenza symptoms which remains a significant burden to public health globally.”
Further details on Phase IIb challenge study of FLU-v (FLU-v 004)
A challenge study conducted by hVIVO using the NIAID virus, methods and analysis as a result of a collaboration between SEEK and NIAID.
A randomised, double-blind, placebo-controlled single-centre trial in collaboration with to assess the efficacy and safety of two different formulation and dosing regimens of FLU-v vaccine administered in healthy adults. In this trial, 123 subjects (aged 18-60 years) were assigned to either placebo or treatment arms.
- The primary endpoint was to assess the incidence of MMID which is defined as evidence of viral shedding in nasopharyngeal swab samples and the presence of at least one symptom.
Supportive regulatory and academic environment
The development of a universal influenza vaccine has become a worldwide public health priority in both industrialised and low-and middle-income countries. A large number of government, academic, public and private organisations (such as, for example, WHO, BARDA, NIH, FDA and EMA) are supportive of development of such a vaccine. These global stakeholders have indicated the benefits of vaccines that induce broad immunity so as to prime the population against newly emerging influenza viruses or other respiratory viruses of pandemic potential.
Significant unmet need
FLU-v is intended to address a number of key issues associated with current annual influenza vaccines whose effectiveness varies from year to year, which need to be redesigned every year, are available in limited quantities due to manufacturing cost, complexity and lead times and which offer limited protection over pandemic influenza. A synthetic universal flu vaccine offering long lasting protection across a broad spectrum of influenza which could be given to a much broader population would be a significant step forward, and a potential future blockbuster in terms of sales.