Altimmune Completes Enrollment in Phase 1b Clinical Trial of NasoShield, a Single Dose Intranasal Anthrax Vaccine Candidate

GAITHERSBURG, Md., Aug. 07, 2020 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that it has completed enrollment in its Phase 1b clinical trial of NasoShield, a single dose intranasal anthrax vaccine candidate. With this milestone, the data readout for the Day 28 immunogenicity endpoint remains on target for Q4 2020.

The clinical trial has enrolled 42 evaluable healthy subjects to receive intranasally administered NasoShield or placebo and be followed for 6 months following dosing. The primary immunogenicity readouts are the serum antibody response to protective antigen and toxin-neutralizing antibody titer 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 other immunologic responses. Nasal mucosal immunity, which can play an important role in the body’s defense against respiratory diseases, is best stimulated by the nasal route of vaccine administration.

The NasoShield program is being developed under a contract with the Biomedical Advanced Research and Development Authority (BARDA), with a total potential value of $133.7 million if all options in the contract (HHSO100201600008C) are exercised. 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.

NasoShield has the potential to be a convenient and simple alternative to the current approved multi-dose anthrax vaccine, as it is intended to confer protection after a single intranasal dose instead of the three-injection regimen required by the only licensed vaccine. Intranasal dosing provides the potential to be administered rapidly and without the need for needles, syringes or trained healthcare personnel in the event of an anthrax incident. In addition, NasoShield’s expected room temperature stability profile may allow for broad distribution of the vaccine without the need for expensive cold-chain logistics, such as refrigeration or freezing.