AstraZeneca initiates Phase IIa study of AZD 9412 (inhaled interferon beta) for severe asthma

AstraZeneca has commenced its Phase IIa study of AZD 9412 (inhaled interferon beta, developed by Synairgen and formerly known as SNG 001). The study population will comprise patients with severe asthma, building on the clinical data from Synairgen’s exploratory Phase lla trial in moderate to severe asthma, which showed that difficult to treat asthma patients appeared to derive most benefit from therapy.

AZD 9412, a novel, inhaled interferon beta, supports the immune system by correcting a deficiency which makes patients vulnerable to respiratory tract viral infections. The programme was out-licensed to AstraZeneca by Synairgen in June 2014 in a global deal worth up to $232 million plus tiered royalties. AstraZeneca is responsible for all development, regulatory and commercial activities and on-going costs associated with this programme. The licence agreement with AstraZeneca also provides the opportunity to expand the clinical programme into other pulmonary diseases, including COPD.

This placebo-controlled Phase IIa trial seeks to enroll 220 asthma patients from countries in both the northern and southern hemispheres (to maximise the benefit of access to a ‘continuous’ cold season). The study population will be GINA Step 4/5 asthma patients (i.e. patients requiring treatment with medium-to-high dose inhaled corticosteroids and a second controller medication) who have a history of severe exacerbations caused by cold viruses. The primary endpoint for the trial is the number of severe exacerbations during the 14 day dosing period.