October 12, 2016
By Alex Keown, BioSpace.com Breaking News Staff
SOUTHAMPTON, England – Shares of Synairgen PLC are down more than 32 percent this morning after AstraZeneca halted a Phase IIa trial for an experimental severe asthma treatment after interim data indicated the drug would not achieve its primary endpoints.
The trial was studying AZD9412, an experimental inhaled interferon beta treatment for asthma, developed by Synairgen and licensed to AstraZeneca in 2014. AstraZeneca limited the trial participants to patients who suffered asthma symptoms thought to have been caused by cold or flu. AstraZeneca said an examination of interim data determined the study may not yield enough meaningful data to achieve primary endpoints. This morning Synairgen said it was informed by London-based AstraZeneca that the interim data showed primary endpoints were not likely to be met due to low numbers of “reported severe exacerbations.” Previous research has shown that common colds can cause severe exacerbations of asthma and that boosting the antiviral defenses of the lung with AZD9412 (inhaled interferon beta, an antiviral protein) during this time could prevent exacerbations from developing, Synairgen said in a statement.
Stephen Holgate, a clinical professor of immunopharmacology at University of Southampton and researcher attached to the Synairgen trial, said “unexpectedly, colds did not cause as many asthma exacerbations as were predicted in this clinical trial population.”
“We hope to learn from the results of this trial which population within severe asthma, or other respiratory diseases, will most benefit from AZD9412 and should be included in future trials,” Holgate said in a statement.
Richard Marsden, Synairgen’s chief executive officer, said the company will continue to review the data from the trial and build on the company’s previous trial outcomes in patients with this form of asthma.
Synairgen said it anticipated full data results from the Phase IIa trial in the first quarter of 2017. Like Synairgen, AstraZeneca said it plans to evaluate the data and focus on the secondary goals of the AZD9412 trial, which could predict when asthma symptoms could worsen due to other factors, Synairgen said in its statement.
In addition to AZD9412, Synairgen has partnered with AstraZeneca to develop an investigational therapy for chronic obstructive pulmonary disease. Additionally, Synairgen has an experimental drug to treat idiopathic pulmonary fibrosis, according to the company website.
The trial stoppage was a bit of a blow for AstraZeneca as the company has been looking to bolster its respiratory pipeline. A focus on respiratory drugs has been key to AstraZeneca’s strategy, particularly since the $575 million acquisition of Takeda Pharmaceutical Company ’s core respiratory business, including global rights to roflumilast, a treatment for chronic obstructive pulmonary disease (COPD). The company is also banking on its new COPD drug, Bevespi Aerosphere, to boost sagging revenue due to stiffer competition from other companies, including GlaxoSmithKline . Earlier this year AstraZeneca revealed positive results from its Phase III trial of its new asthma drug, benralizumab. The drug demonstrated significant reductions in the annual asthma exacerbation rate compared to placebo. Benralizumab, if approved, will be one more step in AstraZeneca bolstering its respiratory pipeline.
Shares of Synairgen, which are traded on the London Stock Exchange, are trading at £23.50 as of 2:49 GMT. Shares of AstraZeneca are slightly down, but nowhere near the levels of Synairgen. AstraZeneca is currently trading at $31.03 per share as of 10:02 a.m.
