Tozorakimab, a first‑in‑class monoclonal antibody targeting interleukin‑33, reduced moderate and severe COPD exacerbations by 29%–34% in two late‑stage randomized trials. The drug (300 mg by injection every four weeks) was generally well tolerated aside from injection‑site reactions. AstraZeneca has secured FDA Priority Review for tozorakimab as an add‑on maintenance therapy for adults with COPD, but peer review and regulatory assessment are pending.
AstraZeneca’s Tozorakimab Cuts COPD Exacerbations in Late‑Stage Trials
STOCK PHOTO/Adobe - PHOTO: A doctor looks at a lung x-ray in an undated stock photo.
AstraZeneca’s experimental monoclonal antibody tozorakimab significantly reduced moderate and severe chronic obstructive pulmonary disease (COPD) exacerbations in two replicate late‑stage clinical trials, the company reported. The data were presented at the European Respiratory Society Congress and are slated for peer‑reviewed publication.
In both randomized, placebo‑controlled studies, adults already receiving inhaled maintenance therapy for COPD were assigned to 300 mg of tozorakimab by injection every four weeks or to placebo. AstraZeneca reported reductions in exacerbation rates versus placebo ranging from 29% to 34% in former smokers and 29% to 30% in the combined population of current and former smokers.
Safety and Mechanism
Aside from injection‑site reactions, tozorakimab was generally well tolerated in the trials, with no new major safety signals reported in the company’s press release. Tozorakimab is a first‑in‑class monoclonal antibody that targets interleukin‑33 (IL‑33), a protein released by injured cells that can drive airway inflammation and mucus dysfunction in COPD. AstraZeneca says the drug binds both forms of IL‑33 to reduce inflammation and interrupt pathways that contribute to disease worsening.
Regulatory Status and Next Steps
The U.S. Food and Drug Administration has accepted tozorakimab for Priority Review as an add‑on maintenance therapy for adults with COPD, which expedites the agency’s evaluation timeline. AstraZeneca is also conducting additional studies to assess the drug’s potential in asthma and other lower respiratory tract diseases.
“These replicate trial results set a new standard for COPD treatment outcomes in a broad population of patients,” said Sharon Barr, Executive Vice President of BioPharmaceuticals R&D at AstraZeneca. Dr. Frank Sciurba of the University of Pittsburgh noted that tozorakimab is the first biologic to demonstrate efficacy for COPD symptom control in late‑stage trials, per the company statement.
Context and Caveats
Nearly 16 million U.S. adults live with COPD, a progressive group of lung diseases that includes emphysema and chronic bronchitis. There is currently no cure; management focuses on symptom control, reducing exacerbations and lifestyle changes such as smoking cessation. Tobacco smoke remains the leading cause of COPD, although up to one in four people with COPD have never smoked.
Important caveats: the published data are company‑released and will be scrutinized in peer review and by regulators. Longer‑term safety, comparative effectiveness against existing therapies, and which patient subgroups derive the most benefit will need further clarification before broad clinical adoption.
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