Altimmune announces ‘positive’ data from Phase 2a study of NasoVax
Altimmune (ALT), announced positive data from its Phase 2a study of NasoVAX intranasal influenza vaccine and provided an update on its Phase 1b study of HepTcell targeted immunotherapy in chronic hepatitis B infection.
Results from the Phase 2a study of NasoVAX intranasal flu vaccine in 60 healthy individuals showed 100% seroprotection in the mid- and high-dose groups.
Results from the Phase 1b study of HepTCell in hepatitis B infection showed that HepTcell was well tolerated at all doses tested, while the unblinded T-cell immunogenicity results were inconclusive.
The randomized Phase 2a study compared a monovalent NasoVAX vaccine against an H1 strain of influenza to intranasal placebo in 60 healthy adults across three dose ranges.
In a parallel open label study, a similar population of 20 subjects were given Fluzone, a licensed injectable influenza vaccine. Blood samples from both studies were tested and the lab was blinded to treatment assignment.
Data demonstrated 100% seroprotection for the middle and high dose groups of NasoVAX as compared to 95% seroprotection with Fluzone. Mean antibody titers against influenza, as measured by the hemagglutinin inhibition and microneutralization assays increased up to 4.3-fold, indicating that high levels of immunity were induced in this study population, even with prior immunity to the influenza strain.
The serum antibody responses were also robust and dose dependent. Seroconversion rates and breadth of antibody response were comparable to Fluzone for the highest NasoVAX dose tested. Additionally, compared to Fluzone, the highest dose of NasoVAX induced over nearly 6-fold higher levels of influenza cellular immunity, an important element in defending against influenza disease.
All doses of NasoVAX were well tolerated and there were no cases of fever, serious adverse events or discontinuations. Rates of local and systemic side effects did not increase with dose and were not statistically different than placebo. Subjects will continue to be followed through six months after vaccination to assess durability of antibody response.
The company plans to submit the full data, which will also include mucosal antibody and serum antibody levels at other time points, for presentation at an appropriate scientific conference later this year.
ALT last traded at $1.60.
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