Altimmune Announces Initial Single-Dose Data from Its NasoShield Phase 1 Study

Altimmune (Nasdaq:ALT) a clinical-stage immunotherapeutics company, today announced initial data from its Phase 1 study of NasoShield under investigation as a potential vaccine against anthrax.

As quoted in the press release:

The purpose of the Phase 1 study was to assess the safety and immunogenicity of a single intranasal dose of NasoShield at four dose cohort levels. An additional cohort received a repeated dose of NasoShield at Day 21.

The study included 145 healthy volunteers.  Four single-dose cohorts of 30 subjects each were randomized to receive either one dose of NasoShield in amounts of 1×10⁸ virus particles (vp), 1×10⁹vp, 1×10¹⁰ vp or 1×10¹¹ vp, three doses of the currently licensed anthrax vaccine, or placebo.  Based on initial data from the single-dose cohorts, NasoShield was safe and well-tolerated with no serious adverse events.  The study also showed limited immunogenicity, possibly indicating that like other anthrax vaccines, NasoShield may require more than one dose.

“We were pleased to see NasoShield had a nearly identical safety profile compared to placebo in this first in man study and much better tolerated than BioThrax®, which uses a three dose schedule and is the only licensed anthrax vaccine.  Additionally, with the ease of nasal delivery, no need for an adjuvant and ability for longer storage at refrigerated and room temperatures, we believe NasoShield remains the best anthrax vaccine candidate in development,” said William J. Enright, president and chief executive officer of Altimmune.

Click here to read the full press release.