AZD-1419

Asthma drug failed to show a statistically clinical improvement in controlling asthma, Dynavax said. Shares of Dynavax Technologies Corporation fell more than 5 percent in Thursday’s trading and is continuing to fall in premarket trading after the company reported that an asthma drug it is co-developing with AstraZeneca failed to meet endpoints in a mid-stage trial. Bay Area-based Dynavax revealed that the drug failed in a filing with the U.S. Securities and Exchange Commission on Thursday. In the filing, Dynavax said it was informed by the U,K,-based pharma giant that initial high-level results from a Phase IIa study of AZD1419, a second-generation TLR9 agonist CpG oligodeoxynucleotide, did not show a statistically significant improvement in controlling asthma. As a result, the drug failed to meet its primary endpoint of the study. Dynavax added that ASD1419 did confirm activation of the TLR9 pathway. Dynavax noted that the proposed mechanism of action of AZD1419 is distinct from that of the other TLR9 agonists the company has under development. The drug appeared to be safe and well tolerated, Dynavax added in its brief filing. The data from the Phase IIa trial will be reviewed by AstraZeneca before the two companies decide on the next steps in the drug’s development. Data from the mid-stage trial will be presented at a future conference, the company said. The failure for AZD1419 comes about two years after a successful Phase Ia study of the safety of four weekly doses of AZD1419 compared to placebo in 45 healthy volunteers. Additional endpoints assessing pharmacodynamics were met, with dose-dependent induction of interferon-regulated genes in sputum and blood cells, the companies said in 2016 as they amended a research and collaboration agreement . The results of the Phase Ia trial were strong enough that the two companies opted to bypass a Phase Ib study and move directly into the Phase IIa trial. The IIa study was initially supposed to be conducted by Dynavax, but due to AstraZeneca’s strong respiratory pipeline and Dynavax’s focus on vaccines and immuno-oncology, the two companies agreed for AstraZeneca to conduct the trial. For AstraZeneca, the Phase IIa failure of AZD1419 comes on the heels of multiple trial failures of two COPD treatments. In August, AstraZeneca said its Phase IIIb drug Bevespi Aerosphere (glycopyrronium/formoterol fumarate) failed to distinguish itself against rival GlaxoSmithKline’s Anoro Ellipta (umeclidinium/vilanterol). In May, the company reported its add-on asthma treatment Fasenra failed to hit endpoints in a Phase III trial of patients with moderate to very severe chronic obstructive pulmonary disease. Fasenra’s failure to achieve a statistically significant reduction of exacerbations in the TERRANOVA trial came hard on the heels of its failure in the Phase III GALATHEA trial . In that trial, Fasenra also failed to achieve a statistically-significant decrease of exacerbations in COPD patients. AstraZeneca has had some good news in respiratory treatments this year. In January AstraZeneca noted its three-in-one inhaler PT010 improved lung function in COPD patients. The trial compared PT010 to Bevespi Aerosphere, Symbicort Turbuhaler and PT009. The U.K. pharma company has been slowly divesting drug assets that are not part of its core business strategy. The company divested two drugs to the privately-held German company, Grünenthal and also sold the rights its respiratory drug, Synagis, a drug used to treat RSV in infants .