Astrazeneca (NYSE:AZN) presented Phase III data for tozorakimab in chronic obstructive pulmonary disease, or COPD, at the 2026 European Respiratory Society Congress in Barcelona, reporting statistically significant reductions in moderate-to-severe exacerbations across two trials and across a broad range of patient subgroups.
The company said the FDA has granted priority review for tozorakimab, an investigational anti-IL-33 monoclonal antibody, with a Prescription Drug User Fee Act action date in the first quarter of 2027.
OBERON and TITANIA results
The primary endpoint measured the annualized rate of moderate-to-severe exacerbations among former smokers. AstraZeneca reported reductions of 29% in OBERON and 34% in TITANIA for that population. In the overall population of current and former smokers, the company reported exacerbation-rate reductions of 30% and 29%, respectively.
The trial population included patients across blood-eosinophil levels, including approximately 40% with fewer than 150 eosinophils, according to Sciurba. About 20% of participants had severe airflow limitation, defined as less than 30% predicted post-bronchodilator FEV1.
In a pooled analysis, Sciurba said the treatment effect was consistent across eosinophil levels, lung-function severity and smoking status. The company cited a 23% reduction in exacerbations among patients with eosinophil counts below 150 cells per microliter, a population for which it said no biologic is currently approved. It also reported reductions of 34% among patients at or above 150 cells per microliter and 43% among those at or above 300 cells per microliter.
Severe exacerbations involving emergency-department visits or hospitalization declined by 36% in one trial and 33% in the other, according to the presentation.
Secondary endpoints and safety
The St. George’s Respiratory Questionnaire, a quality-of-life measure, did not achieve statistical significance in the hierarchical testing sequence. Sciurba said the Exacerbations of Chronic Pulmonary Disease Tool-Respiratory Symptoms score, or E-RS, showed statistically significant symptom improvements in both studies, although those findings were nominally significant following the missed St. George’s endpoint.
FEV1 improved by roughly 25 cubic centimeters in both trials, Sciurba said, reaching statistical significance in OBERON but narrowly missing it in TITANIA.
Overall adverse events were balanced between the treatment and placebo groups except for injection-site reactions, Sciurba said. Major adverse cardiovascular events were uncommon but showed a slight numerical imbalance toward tozorakimab. Sharon Barr, AstraZeneca’s executive vice president of BioPharmaceuticals R&D, said the events in the treatment arm were reviewed by an independent data committee and were not adjudicated as related to the study drug.
Sciurba said he would review the broader safety dataset, while noting that COPD patients often have substantial cardiovascular comorbidity.
Potential market and launch considerations
Ruud Dobber, executive vice president of AstraZeneca’s BioPharmaceuticals Business Unit, said COPD remains an area of substantial unmet need. The company estimates that approximately 6 million people with COPD could be eligible for a biologic by 2030.
Dobber said that improving COPD diagnosis and increasing biologic use would be major launch priorities if tozorakimab is approved. He declined to comment on first-year sales expectations or the eventual product label, saying payer and regulatory discussions still lie ahead.
On use in clinical practice, Sciurba said he would not necessarily switch patients doing well on existing biologics, but he would consider tozorakimab as a first-line biologic option for patients continuing to exacerbate despite maintenance therapy. He said eosinophil testing would likely remain clinically informative even if it is not required for use or reimbursement.
AstraZeneca said tozorakimab’s proposed mechanism may differentiate it from other IL-33 approaches. Barr said the antibody is designed to prevent IL-33 signaling through both the ST2 pathway and the RAGE/EGFR pathway, the latter of which is associated with epithelial remodeling and mucus production. She also cited a separate congress poster reporting a statistically significant reduction in mucus plugs with tozorakimab treatment.
Broader pipeline outlook
Chief Executive Officer Pascal Soriot said AstraZeneca views tozorakimab as a potential asset with peak sales exceeding $5 billion across indications. The company is also studying the medicine in severe lower respiratory tract disease and asthma and is considering additional indications including bronchiectasis, chronic rhinosinusitis and connective-tissue-disease-associated inflammatory interstitial lung disease.
Soriot said AstraZeneca has 12 programs with potential peak sales of at least $5 billion that are expected to generate pivotal data before 2030. He reiterated the company’s confidence in growth after 2030 despite anticipated patent expirations, while saying its business-development strategy has generally prioritized smaller and mid-sized transactions. He added that the company would consider a larger deal in the range of roughly $10 billion to $30 billion if it made strategic, scientific and financial sense.
About Astrazeneca (NYSE:AZN)
AstraZeneca plc is a global biopharmaceutical company focused on the discovery, development and commercialization of prescription medicines. Its principal therapeutic areas include oncology, cardiovascular, renal and metabolic diseases, respiratory and immunology conditions, and rare diseases.
The company’s portfolio includes medicines such as Tagrisso, Imfinzi and Lynparza for cancer; Farxiga for cardiovascular, kidney and metabolic conditions; Fasenra for severe asthma; and Symbicort for respiratory disease.
-online-lending--digital-banking-etf-logo-1200x675.png){kind=logo}