AstraZeneca Strengthens Position In COPD Race With Successful Trials

On Friday, AstraZeneca Plc (NASDAQ:AZN) released positive topline data from Phase 3 OBERON and TITANIA trials of tozorakimab in patients with chronic obstructive pulmonary disease (COPD), also known as smoker’s lung disease.

Positive COPD Data

Tozorakimab is a monoclonal antibody targeting interleukin-33 (IL-33), which inhibits the signalling of the reduced and oxidised forms of IL-33, offering the potential to both reduce inflammation and disrupt the cycle of mucus dysfunction that contributes to COPD worsening.

The data showed that tozorakimab reduced the annualized rate of moderate-to-severe COPD exacerbations compared with placebo.

Primary Endpoint Achieved Across Broad Patient Groups

The trials met the primary endpoint in the primary population of former smokers, and in the overall population, which included former and current smokers, and patients across all blood eosinophil counts and all stages of lung function severity.

Eosinophils are a type of white blood cell that, at increased levels, may contribute to inflammation in respiratory diseases.

Tozorakimab was generally well-tolerated with a favourable safety profile.

In the trials, tozorakimab was studied in patients with COPD still experiencing exacerbations while on inhaled standard of care.

Patients received tozorakimab 300mg or placebo on top of standard of care once every four weeks.

AstraZeneca Competitive Landscape Shows Mixed Results

Additional Phase 3 trials of tozorakimab in COPD, PROSPERO and MIRANDA, are ongoing.

Tozorakimab is also being studied in a Phase 3 trial for severe viral lower respiratory tract disease and in a Phase 2 trial in asthma.

AstraZeneca’s RESOLUTE Phase 3 trial data of Fasenra (benralizumab), released in September 2025, did not achieve statistical significance in the primary endpoint in COPD patients.

In May 2025, Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and Sanofi SA (NASDAQ:SNY) reported mixed data from two COPD trials evaluating itepekimab.

Regeneron and Sanofi’s Dupixent gained FDA approval for COPD in November 2024, marking its sixth U.S. indication since its first use for atopic dermatitis seven years ago.

AstraZeneca Market Opportunity

Nearly 400 million people are diagnosed with COPD, a heterogeneous and progressive disease, and the 3rd leading cause of death globally.

Reuters reported that AstraZeneca has forecast peak annual sales of $3 billion to $5 billion for tozorakimab.

AZN Stock Price Activity: AstraZeneca shares were up 3.68% at $190.15 during premarket trading on Friday, according to Benzinga Pro data.

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