Altimmune has submitted an investigational new drug application to FDA for its NasoVAX intranasal flu vaccine and is planning a Phase 2 study of the product, the company said. The safety and immunogenicity study is anticipated to enroll 60 volunteers, with data available in early 2018, and is expected to be followed by a larger immunogenicity study for a quadrivalent vaccine formulation later that year.
Altimmune Chief Medical Officer Sybil Tasker commented, “Our IND filing is an important milestone for our development program that we hope will eventually lead to the availability of NasoVAX for patients in the US who are at risk for developing the flu. The risks from flu and flu-related complications are well-known, particularly in populations with weakened immune systems. Current vaccines leave significant room for improvement, and according to the CDC, have about a 40% efficacy rate over the ten year period 2005-2015. In pre-clinical studies, NasoVAX generated cross protection against divergent strains. If this is confirmed in the clinic, it will be a very promising sign that the vaccine has the potential to be more efficacious than currently licensed vaccines.”
In addition to NasoVax, the company’s pipeline includes an intranasal anthrax vaccine called NasoShield for which development is funded by a contract with the US Biomedical Advanced Research and Development Authority (BARDA). Earlier this year, Altimmune announced that it would merge with vaccine developer PharmAthene.
Read the Altimmune press release.
