We are developing AZD1419, a novel candidate drug for asthma, under our worldwide collaboration with AstraZeneca. AZD1419 is a proprietary TLR9 agonist and represents a new strategy for the treatment of allergic respiratory diseases. AZD1419 therapy is designed to modify the course of disease by changing the basic immune response to environmental allergens, such as house dust and pollens, leading to a prolonged reduction in asthma symptoms. By contrast, the current mainstays of asthma therapy corticosteroids and bronchodilators, control disease activity or briefly relieve asthma symptoms. Preclinical studies conducted by Dynavax and AstraZeneca, have shown that AZD1419 is capable of producing long lasting disease-modifying effects in a mouse model of atopic asthma.
We have also completed a Phase 1 study in healthy subjects which demonstrated an acceptable safety and tolerability profile and proof of mechanism observed through induction of interferon regulated genes stimulated by AZD1419. We are currently designing a Phase 2 study in moderate to severe asthmatics in partnership with AstraZeneca.
Dynavax is eligible to receive additional development milestones and royalties on worldwide sales of approved products and has the option to co-promote the product in the United States.
According to the World Health Organization, asthma affects 300 million people worldwide. Asthma is a chronic disease of the lungs and is caused primarily by allergic inflammation of the airways. In addition, 210 million people worldwide are affected by COPD, a term used to describe chronic lung diseases that limit airflow in the lungs. Analysts estimate the current worldwide market opportunity for asthma and COPD therapies to be over $15 billion annually.