Adnkronos (Adnkronos) – The complete results of the phase 3 Oberon and Titania studies have shown that tozorakimab, a potential first-in-class monoclonal antibody that acts by inhibiting interleukin 33 (IL-33), is the first biologic drug to demonstrate statistically significant and highly clinically relevant efficacy in reducing moderate to severe exacerbations in a broad population of patients with chronic obstructive pulmonary disease (COPD) who continued to exacerbate despite taking standard therapy.
Tozorakimab showed clinically meaningful benefits across all blood eosinophil levels. The results, reported by AstraZeneca, were published in the New England Journal of Medicine and presented at the European Respiratory Society (ERS) 2026 Congress in Barcelona.
Tozorakimab 300mg, administered once every 4 weeks – the company informs in a note – demonstrated in the primary population composed of former smokers a reduction in moderate and severe COPD exacerbations of 29% (Oberon) and 34% (Titania), respectively, and in the overall patient population composed of current and former smokers a reduction of 30% (Oberon) and 29% (Titania), compared to placebo when added to standard inhaled therapy.
In a pooled analysis of data from the two trials, tozorakimab also demonstrated a clinically meaningful reduction in moderate and severe exacerbations across all prespecified patient subgroups, including those defined by BEC (blood eosinophil count), in the overall population. Additionally, tozorakimab-treated patients with a baseline BEC of less than 150 achieved a 23% reduction in moderate and severe exacerbations; patients with a BEC of 150 or greater achieved a 34% reduction; and patients with a BEC of 300 or greater achieved a 43% reduction.
The full results of the Oberon and Titania studies were presented in a late-breaking oral presentation at the Alert-2 plenary session of the ERS Congress and were simultaneously published in the NEJM.
A poster was published featuring data from the integrated analysis of the two trials, which also showed a reduction in the mucus plug score in patients. Tozorakimab, AstraZeneca emphasizes, is the first biologic to have demonstrated a reduction in mucus plugging in a broad population of COPD patients. The mucus plug score represents an important new outcome measure, as it has been associated with worsening outcomes in COPD. Torozakimab was generally well tolerated, with a favorable safety profile. The only adverse event was an injection site reaction.
Tozorakimab selectively inhibits the activating signal of both the reduced and oxidized forms of IL-33, offering the potential to reduce inflammation and interrupt the cycle of mucus dysfunction that contributes to COPD worsening, the statement explains. The Biologics License Application for tozorakimab, administered once every 4 weeks, has been accepted with Priority Review by the U.S. Food and Drug Administration as an add-on maintenance treatment for adult patients with COPD, AstraZeneca notes. Tozorakimab is currently under regulatory review for the treatment of COPD in major markets, including Europe and China. The drug is also undergoing a Phase 3 study in severe asthma and a Phase 3 study in severe viral lower respiratory tract infections.
"The results of the Oberon and Titania studies represent a sea change for patients with COPD, a disease that still presents a significant unmet clinical need," commented Alberto Papi, Professor of Respiratory Medicine at the University of Ferrara and Director of the Respiratory Unit, Cardio-Respiratory Department, at Sant'Anna Hospital. "The studies," he emphasized, "demonstrated a statistically significant and highly clinically relevant reduction in moderate and severe exacerbations in a broad and heterogeneous patient population regardless of blood eosinophil levels, with reductions in the overall population in the Oberon and Titania studies of 30% and 29%, respectively, compared to placebo. These results demonstrate how tozorakimab offers the prospect of a new approach for patients who continue to exacerbate despite inhaled therapy, with the potential to have a tangible impact on long-term clinical outcomes." Frank Sciurba, professor of Pulmonary and Critical Care Medicine at the University of Pittsburgh and principal investigator of the Luna study program, notes that "the Oberon and Titania studies represent the first time we've seen a biologic for the treatment of COPD achieve efficacy in a broad patient population regardless of blood eosinophil levels, including patients with baseline eosinophil counts below 150 and regardless of smoking status. These unprecedented results, supported by a favorable safety profile," the specialist notes, "highlight tozorakimab's potential as a breakthrough treatment for the millions of patients living with COPD who remain at risk despite treatment with standard inhaled therapy."
Sharon Barr, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: "The groundbreaking results for tozorakimab in the two studies presented today set a new standard for COPD treatment outcomes across a broad patient population. AstraZeneca has clinically validated the innovative approach of targeting the activating signal of the two forms of IL-33 to reduce both inflammation and the cycle of mucus dysfunction. Following the FDA's Priority Review of the drug, we look forward to making this treatment available to patients as soon as possible."
News
webinfo@adnkronos.com (Web Info)