A new drug, tozorakimab, has shown promise in reducing symptoms of chronic obstructive pulmonary disease (COPD) in former and current smokers, according to the results of late-stage clinical trials.
The medication, developed by AstraZeneca, is the first biologic drug to demonstrate efficacy in treating COPD symptoms, according to Dr. Frank Sciurba, professor of Pulmonary and Critical Care Medicine at the University of Pittsburgh, in a press release from AstraZeneca.
Results from two clinical trials, presented at the European Respiratory Society Congress and slated for publication in a peer-reviewed journal, indicated that patients receiving standard inhaler regimens for COPD management experienced a significant reduction in moderate and severe COPD exacerbations when treated with tozorakimab compared to a placebo. Patients were randomized to receive either 300 milligrams of tozorakimab via injection once every four weeks or a placebo.
The reduction in symptoms ranged from 29% to 34% among former smokers and 29% to 30% among current and former smokers. Aside from localized reactions at the injection site, tozorakimab was well-tolerated with no significant side effects reported.
Tozorakimab functions as a monoclonal antibody that binds to interleukin-33, a protein released by damaged cells that triggers inflammation associated with conditions like COPD. AstraZeneca is also investigating the drug's potential for treating asthma and lower respiratory tract disease.
The U.S. Food and Drug Administration (FDA) has accepted tozorakimab for priority review as an add-on maintenance drug for adults with COPD. This expedited review process suggests the agency will move swiftly toward potential approval.
COPD affects nearly 16 million adults in the U.S. and is a group of lung diseases that worsen over time, according to the Centers for Disease Control and Prevention (CDC). The most common types are emphysema and bronchitis, and there is no cure. Treatment typically involves lifestyle changes, such as smoking cessation, and medications. Tobacco smoke is the primary cause of COPD in the U.S.
COPD ranks among the top 10 leading causes of death in the U.S. In 2021, more than 138,825 people died from the disease, according to the American Lung Association. While often associated with smokers and former smokers, the CDC notes that up to one in four COPD patients have never smoked.
"Today's groundbreaking tozorakimab results, from two replicate trials, 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, in a statement. "AstraZeneca has validated the novel approach of targeting the two forms of IL-33 to both decrease inflammation and disrupt the cycle of mucus dysfunction. With our FDA Priority Review, we look forward to bringing this treatment to patients as quickly as possible."