FLU-v has been developed by Imutex, 49%-owned by Open Orphan unit hVIVO
The results of a successful phase IIb trial of a potential flu vaccine being developed by an Open Orphan PLC (LON:ORPH) joint-venture have been written up in a peer-reviewed article carried by a scientific journal.
The data from FLU-v 004 challenge study underlined its ability to reduce mild-to-moderate symptoms of the illness.
FLU-v has been developed by Imutex, 49%-owned by Open Orphan unit hVIVO, as the first ‘universal’, broad-spectrum influenza vaccine.
The publication of the results in the periodical ‘npj Vaccines’ follows hard on the heels of results from a separate field assessment of the drug, which revealed “cellular and humoral immunogenicity” from a single dose of adjuvanted FLU-v.
In other words, the jab immediately provoked an immune response.
Imutex, meanwhile, is scheduling meetings with regulators on both sides of the Atlantic ahead of further trials.
“Progression to larger phase III studies with FLU-v can further describe the cellular immune response and evaluate how the vaccine interacts with influenza disease,” said Open Orphan chief executive Trevor Phillips.
Chairman Cathal Friel added: “The need for better, more broadly protective vaccines against influenza is a high priority worldwide, and few new vaccines have demonstrated efficacy in humans as seen in the results of the challenge study for FLU-v 004.
“This is the first universal influenza vaccine that has shown this protection from influenza and reduction of symptoms in late-stage studies and together with the highly statistical immune results reported in a peer review article earlier this week means that the risk of failure in a phase III setting is greatly reduced compared with entering into phase III studies with no efficacy data.”
Link here to view the original Proactive article