Altimmune, Inc. announced today dosing of the first patient in the Company’s Phase 1b clinical trial of NasoShield, a single dose intranasal anthrax vaccine candidate.
“NasoShield is the only single dose anthrax vaccine in development that is supported by BARDA, and has the potential to provide a significant improvement over the available two- and three-dose injectable anthrax vaccine regimens”, said Vipin K. Garg, Ph.D., President and CEO of Altimmune. “We are excited to begin enrollment in this important clinical trial as this is an opportunity to further validate our vaccine platform and its broadly-applicable intranasal approach, and we look forward to reviewing the results later this year.”
The clinical trial is expected to enroll 42 healthy subjects who will receive intranasally administered NasoShield or placebo and be followed for 6 months. The primary immunogenicity readouts are the serum titers of antibody to protective antigen and toxin-neutralizing antibody 28 and 56 days after dosing. As with Altimmune’s other vaccine programs, stimulation of a mucosal IgA immune response in the nasal cavity will also be assessed as a potential additional benefit to serum antibody responses. Nasal mucosal immunity is not stimulated by the vast majority of vaccines but is likely to play an important role in the body’s defense against respiratory diseases.
Because NasoShield is intended to protect against anthrax after a single intranasal dose, it has the potential to be a convenient and simple alternative to the only approved vaccine, which must be given as a series of three injections over 1 month. The simplified immunization route and schedule, together with the reliable stability at ambient temperature may allow NasoShield to be deployed in an anthrax event more easily and faster than the currently approved vaccine. At the conclusion of the Phase 1b NasoShield trial, BARDA will have the option of exercising the remaining contract options valued at approximately $105 million to enable Phase 2 development.
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