Synairgen, a drug discovery and development company focused on advancing novel approaches for severe respiratory conditions recently announced that AstraZeneca has initiated its Phase IIa clinical trial of AZD9412.
The drug, which was originally developed by Synairgen (SNG001), is inhaled interferon beta that supports the immune system by correcting a deficiency that makes patients vulnerable to respiratory tract viral infections.
For the clinical trial, the researchers will recruit patients suffering with severe asthma. The study will build on the clinical results from the company’s exploratory Phase lla clinical study, which assessed the drug in patients with mild to severe asthma. The study results revealed that difficult to treat asthma patients seemed to gain more benefits from the drug.
In June 2014, the program was out-licensed by Synairgen to AstraZeneca in a global agreement value of up to $232 million plus tiered royalties. Under the agreement, AstraZeneca has the responsibility to develop the therapy and be held responsible for all the commercial and regulatory activities as well as with the on-going costs related to the program.
The licence agreement between Synairgen and AstraZeneca also offers the prospect of expanding the program to other pulmonary conditions such as COPD.
The new Phase IIa placebo-controlled clinical trial aims to enroll a total of 220 patients with severe asthma from countries in both Northern and Southern Hemispheres. This will help to maximize the benefit of access to a ‘continuous’ cold season.
The clinical trial is going to involve patients with GINA Step 4/5 asthma. These patients require medium-to-high dose inhaled corticosteroid treatment, as well as a second controller drug. Patients inclusion criteria also involves having a history of severe exacerbations caused by cold viruses.
The clinical trial primary endpoint includes the number of severe exacerbations experienced by the patients during the 14 days of treatment.