Tozorakimab Met Primary End Point in Phase 3 Trial, Improving COPD

Tozorakimab, a potential first-in-class biologic, has met its primary endpoint in the pivotal phase 3 MIRANDA (NCT06040086) trial, demonstrating a statistically significant and clinically meaningful reduction in the annualized rate of moderate-to-severe exacerbations for patients with chronic obstructive pulmonary disease (COPD). These positive high-level results were observed in the primary population of former smokers as well as the overall study population, which included both current and former smokers across all stages of lung function severity and all blood eosinophil counts.¹

In the trial, patients received a 300 mg dose of tozorakimab or a placebo administered every 2 weeks on top of their existing standard-of-care inhaled therapies. This success follows previously announced positive results from the replicate OBERON (NCT05166889) and TITANIA (NCT05158387) phase 3 trials, which investigated a four-week dosing interval of the same medication.^1,2

About The Trials

The phase 3 LUNA development program, which encompasses the MIRANDA, OBERON, TITANIA, and the ongoing PROSPERO (NCT05742802) long-term extension trials, aims to provide robust evidence for this new therapeutic class. Beyond COPD, tozorakimab is also being investigated for its efficacy in treating severe viral lower respiratory tract disease and asthma.

Safety data from the MIRANDA trial indicated that the drug was generally well tolerated, maintaining a favorable safety profile consistent with previous clinical investigations. These data will be submitted to global regulatory authorities and shared with the scientific community at an upcoming medical meeting as the industry looks toward new options for managing this progressive and often debilitating condition.

The Pharmacist’s Role

For pharmacists and clinicians, tozorakimab represents a novel pharmacological approach as a monoclonal antibody that binds to IL-33, a cytokine positioned at the top of the inflammatory cascade. Unlike other agents, tozorakimab uniquely inhibits the signaling of both the reduced and oxidized forms of IL-33, a mechanism designed to simultaneously reduce inflammation and disrupt the cycle of mucus dysfunction that characterizes progressive lung damage. This differentiated mechanism of action is particularly relevant given that COPD is a complex, heterogeneous disease involving chronic inflammation of the airways and persistent airflow limitation.^1,3

“Prior to starting therapy, medication education, including dosing and administration, inhalation technique, storage and disposal requirements, and [adverse] effects, should be reviewed,” Nishita Hira, PharmD, CSP, clinical program manager for Walgreens Specialty Pharmacy in Tampa, Florida, said.⁴ “Lifestyle modifications, such as smoking cessation, diet, and exercise, should be discussed as clinically appropriate. Monthly follow-up, including reassessing inhaler techniques, screening, and counseling for adverse events and adherence barriers, is important to ensure continued adherence.”

The clinical urgency for such an intervention is underscored by the fact that COPD remains the third leading cause of death globally, affecting nearly 400 million people. Despite adherence to current standard inhaled maintenance therapies, more than half of patients still experience exacerbations that can lead to life-threatening cardiopulmonary events, such as heart attacks, and increased mortality.

Within the United States alone, COPD exacerbations are responsible for over 2500 emergency department visits every day, and historical data suggests that only 50% of patients survive more than 3.5 years after their first severe exacerbation.

Pharmacists continue to play a vital role in COPD management due to the overwhelming nature of the disease combined with complex medication regimens and financial barriers associated with care.

“We have the face-to-face and opportunities to discuss their medications and maybe more importantly, what’s not covered by their insurance and what options might look like,” Steve Coomes, PharmD, owner of Aubrey Health Mart Pharmacy in Aubrey, Texas, said. “One of the problems with today’s treatment in COPD is a lot of the products being promoted and prescribed are really expensive.”

READ MORE: Respiratory Resource Center

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REFERENCES

1. Tozorakimab met primary endpoint in phase III Miranda trial in patients with COPD. News release. AstraZeneca. April 20, 2026. Accessed April 20, 2026. https://www.astrazeneca-us.com/content/az-us/media/press-releases/2026/Tozorakimab-met-primary-endpoint-in-Phase-III-MIRANDA-trial-in-patients-with-COPD.html

2. Tozorakimab met primary endpoint in both Oberon and Titania phase III trials in patients with COPD. News release. AstraZeneca. March 27, 2026. Accessed April 20, 2026. https://www.astrazeneca-us.com/content/az-us/media/press-releases/2026/Tozorakimab-met-primary-endpoint-in-both-OBERON-and-TITANIA-Phase-III-trials-in-patients-with-COPD.html

3. Mayo Clinic. COPD. March 13, 2026. Accessed April 20, 2026. https://www.mayoclinic.org/diseases-conditions/copd/symptoms-causes/syc-20353679

4. Loria K. Pharmacists help patients stay adherent to COPD therapy, improving overall quality of life. Drug Topics. October 17, 2025. Accessed April 20, 2026. https://www.drugtopics.com/view/pharmacists-help-patients-stay-adherent-to-copd-therapy-improving-overall-quality-of-life