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hVIVO’s flu vaccine set for phase III trials as regulators confirm mid-stage primary endpoint met

Secondary endpoints were confirmed last March and further analysis of the data has now found that the primary endpoint in symptom reduction was also met
man with flu
hVIVO thinks FLU-v has the potential to be a blockbuster drug

hVIVO PLC (LON:HVO) shares zipped higher on Thursday after US regulators found that its flu vaccine did achieve its primary endpoint in last year’s mid-stage clinical trial.

The National Institute of Allergy and Infectious Diseases (NIAID) confirmed last March that FLU-v had met key secondary endpoints in symptom reduction.

READ: hVIVO builds on position of strength in challenge trials

But the Institute said it needed more time to assess the primary endpoint as its initial analysis was based on results from a less sensitive assay, which sometimes misses the presence of influenza virus.

“The more sensitive assay, routinely utilised by NIAID to assess the presence of a virus, identified more cases of influenza infection than had originally been determined, resulting in the achievement of statistical significance,” said hVIVO executive chairman Trevor Phillips.

“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 final results are further verification that FLU-v is achieving measures of clinical efficacy and is now positioned to enter phase III.”

Potential blockbuster

hVIVO and its partner, SEEK Group, have a good idea of how they want to design the phase III trial which they will discuss with regulatory authorities at their upcoming meetings.

Currently, flu vaccines have to be redesigned every year as the flu virus evolves rapidly.

One of the major plus-points for FLU-v is that it offers long-lasting protection against a broad spectrum of influenza which hVIVO believes could be given to a much broader population.

“[That] would be a significant step forward, and a potential future blockbuster in terms of sales.”

By afternoon trading, hVIVO shares had leapt 36.8% higher to 39p.

 -- Updates share price --

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