CAMBRIDGE, United Kingdom, April 20, 2026

AstraZeneca has reported positive results from its pivotal Phase III MIRANDA trial, demonstrating that tozorakimab, a novel IL-33-targeting monoclonal antibody, achieved its primary endpoint by significantly reducing moderate-to-severe exacerbations in patients with chronic obstructive pulmonary disease (COPD). The findings reinforce the therapy’s potential as a first-in-class biologic addressing a major unmet need in respiratory medicine.

Phase III Trial Demonstrates Significant Clinical Benefit

The MIRANDA Phase III trial evaluated tozorakimab 300 mg administered every two weeks in patients with symptomatic COPD who continued to experience exacerbations despite receiving standard inhaled therapies. The study showed a statistically significant and clinically meaningful reduction in the annualised rate of moderate-to-severe COPD exacerbations, both in former smokers (primary population) and across the broader patient population, including current smokers and individuals with varying levels of disease severity.

These results are particularly important given that more than 50% of COPD patients continue to experience exacerbations even with standard-of-care treatments, leading to increased risks of hospitalisation, cardiopulmonary complications, and mortality. The MIRANDA findings build upon earlier positive outcomes from the OBERON and TITANIA Phase III trials, further strengthening the evidence supporting tozorakimab’s clinical efficacy.

Additionally, the therapy demonstrated a favorable safety and tolerability profile, consistent with previous studies, highlighting its potential suitability for long-term use in chronic respiratory disease management.

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First-in-Class IL-33 Targeting Mechanism

Tozorakimab represents a novel therapeutic approach by targeting interleukin-33 (IL-33), a key driver of inflammation in respiratory diseases. Unlike conventional therapies, tozorakimab uniquely inhibits both reduced and oxidised forms of IL-33, enabling it to suppress inflammation and disrupt mucus dysfunction, which are central to the progression of COPD.

This dual mechanism positions tozorakimab as a differentiated biologic therapy, capable of addressing the underlying causes of disease rather than just managing symptoms. The drug is also being investigated in additional indications, including severe viral lower respiratory tract disease (Phase III) and asthma (Phase II), reflecting its broader therapeutic potential.

The therapy has received Fast Track Designation from the U.S. FDA for COPD and related respiratory conditions, further emphasizing its importance in addressing high unmet medical needs in pulmonary care.

Addressing a Global Health Burden

COPD affects nearly 400 million people worldwide and is the third leading cause of death globally, representing a significant public health challenge. The disease is characterized by persistent airflow limitation, chronic inflammation, and progressive respiratory decline, often resulting in reduced quality of life and increased healthcare burden.

Exacerbations play a critical role in disease progression, with each episode increasing the risk of future complications, hospitalisations, and mortality. Despite advancements in inhaled therapies, many patients remain inadequately controlled, highlighting the urgent need for innovative biologic treatments like tozorakimab.

AstraZeneca’s ongoing Phase III LUNA clinical program, which includes multiple large-scale trials, aims to further validate the long-term efficacy and safety of tozorakimab, supporting potential regulatory submissions and future commercialization.

The positive results from the MIRANDA Phase III trial mark a significant milestone in the development of tozorakimab, positioning it as a potential first-in-class biologic therapy for COPD. With its innovative mechanism of action, strong clinical efficacy, and favorable safety profile, AstraZeneca is advancing a promising solution that could transform the treatment landscape for millions of patients suffering from chronic respiratory diseases worldwide.

Source: AstraZeneca press release