Altimmune Announces Initial Single-Dose Data from Its NasoShield Phase 1 Study
Studies funded by BARDA
GAITHERSBURG, Md., Aug. 31, 2018 (GLOBE NEWSWIRE) — Altimmune, Inc. (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. 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), 1×109 vp, 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.
The NasoShield program is funded through a contract (HHSO100201600008C) with the Biomedical Advanced Research and Development Authority(BARDA), which runs through September 2021, and if all options are exercised, is expected to provide funding through the end of Phase 2 development. Immunogenicity data for the two-dose cohort will be available in the fourth quarter of this year.
Altimmune is a clinical-stage immunotherapeutics company focused on the development of products to stimulate robust and durable immune responses for the prevention and treatment of disease and on the development of two next-generation anthrax vaccines that are intended to improve protection and safety while having favorable dosage and storage requirements compared to other anthrax vaccines.
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