In a previously reported Phase 1a study of the safety of 4 weekly doses of AZD1419 compared to placebo in 45 healthy volunteers, ascending doses were well tolerated with no serious adverse events observed in treated subjects.
Additional endpoints assessing pharmacodynamics were met, with dose-dependent induction of interferon-regulated genes in sputum and blood cells.
On the basis of these encouraging results, the companies decided to bypass a planned Phase 1b trial and proceed to Phase 2a, a study that was to be conducted by Dynavax.
As trial design progressed, AstraZeneca elected, with Dynavax’s full support, to conduct the study in house, consistent with AstraZeneca’s commitment to respiratory disease, one of the company’s three main therapy areas, and Dynavax’s increasing strategic focus on vaccines and immuno-oncology.
Dynavax CEO Eddie Gray said: "Our partnership with AstraZeneca is focused on the advancement of AZD1419. This amendment will promote that objective by leveraging AstraZeneca’s expertise in international clinical development of respiratory products."
AZD1419 is a proprietary, second-generation TLR9 agonist CpG oligodeoxynucleotide formulated for inhalation use. The Phase 2a study is planned to be initiated in 2016.