AstraZeneca's experimental COPD drug shows strong results in late-stage trials

AstraZeneca's experimental biologic drug tozorakimab demonstrated strong results in two Phase 3 trials, reducing moderate-to-severe COPD flare-ups by approximately 30%. The drug targets interleukin-33 to reduce inflammation and mucus production. Crucially, tozorakimab showed efficacy across a broad patient population, including those with low blood eosinophil counts who currently lack biologic options. The FDA has granted priority review, with potential approval expected in early 2027.

Tozorakimab late-stage trial results

• ▪AstraZeneca's tozorakimab is designed to inhibit two distinct interleukin-33 pathways, addressing both inflammation and mucus production, unlike previous interleukin-33 treatments
• ▪AstraZeneca's experimental biologic drug tozorakimab significantly reduced chronic obstructive pulmonary disease flare-ups in two Phase 3 clinical trials
• ▪The overall safety profile of AstraZeneca's tozorakimab was similar to placebo in Phase 3 trials, with injection-site reactions being the most frequent adverse event
• ▪AstraZeneca's tozorakimab targets interleukin-33, a protein released by damaged cells that drives airway inflammation and mucus production in chronic obstructive pulmonary disease
• ▪The Phase 3 clinical trials evaluated AstraZeneca's tozorakimab, a monoclonal antibody administered via subcutaneous injection every four weeks, over a one-year period

COPD exacerbation reduction efficacy

• ▪In Phase 3 trials, AstraZeneca's tozorakimab reduced moderate-to-severe flare-ups by 29% and 34% in former smokers, and by 30% and 29% in current and former smokers
• ▪In Phase 3 trials, AstraZeneca's tozorakimab reduced moderate-to-severe flare-ups by 23% in patients with blood eosinophil counts below 150, 34% at or above 150, and 43% at or above 300
• ▪Patients receiving AstraZeneca's tozorakimab experienced approximately 29% to 34% fewer moderate-to-severe chronic obstructive pulmonary disease exacerbations compared to those receiving a placebo
• ▪In Phase 3 trials, patients receiving AstraZeneca's tozorakimab had moderate or severe exacerbation rates of 1.41 and 1.44 events, compared to 2.00 and 2.03 events for placebo

FDA priority review timeline

• ▪The U.S. Food and Drug Administration accepted AstraZeneca's tozorakimab for priority review as an add-on maintenance treatment for adults with chronic obstructive pulmonary disease
• ▪AstraZeneca raised its peak annual sales forecast for the chronic obstructive pulmonary disease drug tozorakimab to more than $5 billion to support its 2030 revenue targets
• ▪AstraZeneca expects potential U.S. Food and Drug Administration approval for the chronic obstructive pulmonary disease drug tozorakimab in the first quarter of 2027

Broad patient population benefit

• ▪If approved, AstraZeneca's tozorakimab would become the first biologic treatment option for chronic obstructive pulmonary disease patients with lower blood eosinophil counts under 150
• ▪AstraZeneca's tozorakimab demonstrated clinical efficacy across a broad chronic obstructive pulmonary disease population, regardless of smoking status, lung function severity, or blood eosinophil levels
• ▪Dr. Meilan Han of the University of Michigan Health stated that doctors face open questions regarding whether to prescribe AstraZeneca's tozorakimab before or after existing biologics like Dupixent and Nucala

COPD disease burden statistics

• ▪Chronic obstructive pulmonary disease affects an estimated 16 million to 26 million people in the United States and is a leading cause of death globally
• ▪According to the Centers for Disease Control and Prevention, tobacco smoke is the primary cause of chronic obstructive pulmonary disease in the United States, though up to 25% of patients have never smoked