Dynavax and AstraZeneca to Advance TLR9 Agonist for Treatment of Asthma Into Phase 2a Clinical Study
AZD1419 is a proprietary, second-generation TLR9 agonist CpG oligodeoxynucleotide formulated for inhalation use. The decision to accelerate this potential disease-modifying therapeutic into Phase 2, eliminating the previously planned Phase 1b study, was based on the positive results of a Phase 1a study in 45 healthy volunteers. The primary study objective was assessment of the safety of 4 weekly doses of AZD1419 or placebo. 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.
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AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com.
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This press release contains "forward-looking statements," including statements related to expected payments under our AstraZeneca agreement and the expected initiation of a Phase 2a trial. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including whether the study will receive timely regulatory approval to proceed or results of completed studies can be replicated in further studies as well as difficulties or delays in discovery or development, initiation and completion of studies, the results of those studies and the impact of those results on the initiation and completion of subsequent studies and issues arising in the regulatory process; achieving our AstraZeneca agreement objectives; our ability to obtain additional financing to support our operations; and other risks detailed in
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