tozorakimab (MEDI3506) / AstraZeneca - LARVOL DELTA

Updates in COPD Management: From Inflammatory Pathways to Targeted Therapies. (PubMed, Eur J Clin Invest) - "COPD management is evolving toward precision medicine, guided by inflammatory phenotypes, biomarkers, and individualised risk profiles. Continued investigation into targeted biologics, anti-inflammatory agents, and incorporating biomarkers into clinical practice may improve outcomes and reduce disease burden."

Biomarker • Journal • Review • Cardiovascular • Chronic Obstructive Pulmonary Disease • Cognitive Disorders • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • IL33

Tozorakimab restores epithelial dysfunction in COPD (ERS 2026) - "Tozorakimab is a human therapeutic mAb with a dual pharmacological profile that can inhibit both IL-33 activities with demonstrated ability to reverse epithelial dysfunction in COPD. Tozorakimab is under clinical investigation in COPD. Table."

Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases • EGFR • IL33 • IL5 • MUC5AC

Efficacy of Biologics in Patients with Moderate to Very Severe COPD: A Systematic Review. (PubMed, Int J Chron Obstruct Pulmon Dis) - "Sixteen publications were included, covering 12 studies of seven biologics (astegolimab, benralizumab, dupilumab, itepekimab, mepolizumab, tezepelumab and tozorakimab). Improvements in SGRQ total score were observed in patients with BEC ≥300 cells/µL (dupilumab and tezepelumab) and astegolimab improved SGRQ-C total score in patients with BEC >170 cells/µL. Overall, AECOPD reductions and improvements in lung function and health-related quality of life in patients with moderate to very severe COPD varied by biologic and baseline BEC subgroup; within studies, efficacy was generally greater in patients with an elevated baseline BEC, suggesting these patients may benefit most from biologic treatment."

Journal • Review • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Late Breaking Abstract - Tozorakimab reduces the number of lung segments with mucus plugs in patients with COPD at high risk of exacerbations: integrated analysis of the replicate OBERON and TITANIA phase 3 studies (ERS 2026) - P3 | "Tozorakimab is the first biologic shown to significantly reduce the number of lung segments with mucus plugs in a broad population of current and former smokers with COPD."

Clinical • Late-breaking abstract • P3 data • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases • IL33

Late Breaking Abstract - Tozorakimab Modulates COPD Airway Biology Beyond Type 2 Inflammation: Insights from the Ph2 FRONTIER‑4 Study (ERS 2026) - P3 | "In FRONTIER-4, tozorakimab inhibited markers beyond T2 inflammation in both the upper and lower airways. These data suggest potential benefit in a broad COPD population and support future analysis in the ongoing Ph3 Studies (NCT05166889, NCT05158387, NCT06040086). 1.Singh D et al."

Late-breaking abstract • Chronic Obstructive Pulmonary Disease • Immunology • Inflammation • Respiratory Diseases • IL33

Late Breaking Abstract - PRT-089Q01, an IND-enabling anti-interleukin-33 antibody, represents a potential best-in-class agent for chronic obstructive pulmonary disease (ERS 2026) - "Notably, Tozorakimab and Itepekimab recognize distinct epitopes on IL-33red. With its unique molecular format, potency and favorable developability, PRT-089Q01 holds great potential to become a best-in-class antibody targeting IL-33."

Late-breaking abstract • Chronic Obstructive Pulmonary Disease • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • CXCL8 • IFNG • IL33 • IL6

Late Breaking Abstract - Tozorakimab to prevent COPD exacerbations: results from the replicate OBERON and TITANIA phase 3 studies (ERS 2026) - P3 | "Tozorakimab significantly reduced the rate of moderate/severe exacerbations in a broad population of current and former smokers with COPD and was well tolerated."

Late-breaking abstract • P3 data • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases • IL33

Standardized double‑read plus adjudication improves the reproducibility of CT mucus plug scoring in the LUNA Ph3 tozorakimab COPD clinical trials (ERS 2026) - "A standardized DR+A paradigm for CT mucus plug scoring in a large Phase 3 COPD program yielded excellent reproducibility, supporting DR+A as the preferred approach for mucus plug endpoints in clinical trials. Results across the full LUNA CT dataset will be presented."

Clinical • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

TOZORAKIMAB TREATMENT IMPROVES DAILY RESPIRATORY SYMPTOMS IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE: RESULTS FROM THE OBERON AND TITANIA STUDIES (CHEST 2026) - No abstract available

Clinical • Late-breaking abstract • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

LONG-TERM EFFICACY AND SAFETY OF TOZORAKIMAB IN PATIENTS WITH COPD: AN INTEGRATED ANALYSIS OF OBERON, TITANIA AND THE PROSPERO EXTENSION STUDY (CHEST 2026) - No abstract available

Clinical • Late-breaking abstract • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Tozorakimab is currently under regulatory review for the treatment of COPD in major markets, including the EU and China. (AstraZeneca Press Release)

China filing • EMA filing • Chronic Obstructive Pulmonary Disease • Immunology

The Biologics License Application for tozorakimab 300mg, administered once every four weeks, has been accepted for Priority Review by the US Food and Drug Administration as an add-on maintenance treatment for adult patients with COPD. (AstraZeneca Press Release) - "Full results from the positive Phase III OBERON and TITANIA trials showed that tozorakimab is the first biologic to demonstrate statistically significant and highly clinically meaningful efficacy in reducing moderate and severe exacerbations in a broad population of patients with chronic obstructive pulmonary disease (COPD) still experiencing exacerbations while on inhaled standard of care....The Prescription Drug User Fee Act date is anticipated during the first quarter of 2027 following use of a Priority Review voucher."

FDA approval • FDA filing • Priority review • Chronic Obstructive Pulmonary Disease • Immunology

Tozorakimab demonstrated statistically significant and highly clinically meaningful reduction in COPD exacerbations in OBERON and TITANIA Phase III trials (AstraZeneca Press Release) - "In a pooled analysis of OBERON and TITANIA, tozorakimab also demonstrated clinically meaningful reductions in moderate and severe exacerbations in all prespecified patient subgroups including those defined by BEC in the overall population. In addition, patients on tozorakimab with a baseline BEC of less than 150 achieved a 23% reduction in moderate and severe exacerbations; patients at or above 150 achieved a 34% reduction; and patients at or above 300 achieved a 43% reduction...These data were presented today as a late-breaker oral presentation in the ALERT-2 plenary session at the European Respiratory Society Congress...In a separate poster presentation at the ERS Congress 2026, AstraZeneca presented results from an integrated analysis of OBERON and TITANIA that demonstrated a reduction in patients’ mucus plug score."

Late-breaking abstract • P3 data • Chronic Obstructive Pulmonary Disease • Immunology

Tozorakimab: FDA action date for COPD in Q1 2027 (AstraZeneca) - ERS 2026

PDUFA • Chronic Obstructive Pulmonary Disease • Immunology

Tozorakimab: “Tozorakimab significantly reduced the annualized rate of moderate/severe exacerbations by up to 34% versus placebo”; Chronic obstructive pulmonary disease (AstraZeneca) - ERS 2026: “In a prespecified pooled analysis, tozorakimab reduced the rate of moderate/ severe exacerbations across subgroups defined by screening BEC, baseline airflow obstruction and smoking status (current/former)”

P3 data • Chronic Obstructive Pulmonary Disease • Immunology

Tozorakimab to Prevent COPD Exacerbations. (PubMed, N Engl J Med) - P3 | "Among patients with COPD, treatment with tozorakimab resulted in a significantly lower rate of moderate or severe exacerbations than placebo in the cohort of former smokers and in the overall population of current and former smokers. (Funded by AstraZeneca; OBERON ClinicalTrials.gov number, NCT05166889; TITANIA ClinicalTrials.gov number, NCT05158387.)."

Journal • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases • IL33

Identifying molecular signatures underpinning treatment responses to novel therapeutics influencing COVID-19 outcomes. (PubMed, J Immunol) - "The ACCORD trial evaluated 3 investigational treatments-bemcentinib, tozorakimab, and zilucoplan-in patients hospitalized with COVID-19, each of which has demonstrated clinical efficacy. These insights support the need for adaptive precision medicine approaches tailored to individual, evolving immune trajectories. Moreover, the immunological mechanisms targeted by these repurposed immunomodulatory therapies may inform treatment strategies across a broader spectrum of immune-mediated diseases beyond COVID-19."

Journal • Infectious Disease • Inflammation • Novel Coronavirus Disease

Safety Profile of Tozorakimab (an Anti-IL-33 Monoclonal Antibody): Data from the FRONTIER Phase 2 Program. (PubMed, Biologics) - "No clinically significant trends were observed in laboratory or vital-sign parameters, and immunogenicity was low. Tozorakimab was well tolerated across a range of inflammatory diseases, with no safety concerns identified."

Clinical • Journal • P2 data • Asthma • Atopic Dermatitis • Cardiovascular • Chronic Obstructive Pulmonary Disease • Congestive Heart Failure • Dermatitis • Dermatology • Diabetic Nephropathy • Heart Failure • Immunology • Inflammation • Nephrology • Pulmonary Disease • Renal Disease • Respiratory Diseases • IL33

Tozorakimab Reduces COPD Exacerbations via IL-33 Blockade in Phase 3 trial (Medical Dialogues) - "The phase 3 MIRANDA trial showed that add-on tozorakimab significantly reduced moderate-to-severe exacerbations in patients with chronic obstructive pulmonary disease (COPD), particularly in former smokers already on inhaled therapy. In MIRANDA, patients received tozorakimab 300mg or placebo on top of standard of care once every two weeks....Tozorakimab was generally well tolerated with a favorable safety profile consistent with previous trials. The data will be submitted to regulatory authorities and shared with the scientific community at an upcoming medical meeting."

P3 data • Chronic Obstructive Pulmonary Disease • Immunology

Tozorakimab: Regulatory decision for COPD (based on OBERON and TITANIA trials) in H2 2027 (AstraZeneca) - H1 & Q2 2026 Results: Regulatory decision for COPD (based on MIRANDA and PROSPERO trials) in H2 2027

Approval • Chronic Obstructive Pulmonary Disease • Immunology

Tozorakimab: Data from P2 UMBRIEL trial (NCT06932263) for uncontrolled asthma in H2 2027 (AstraZeneca) - H1 & Q2 2026 Results

P2 data • Asthma • Immunology

Phase III LUNA clinical programme: design of four randomised, double-blind, placebo-controlled studies assessing the efficacy and safety of tozorakimab in patients with symptomatic COPD and a high risk of exacerbations. (PubMed, BMJ Open Respir Res) - P3 | "Results of the studies will be submitted to the EU Clinical Trials Information System within a year from the global end of trial data in all participating countries and will be published or presented at scientific meetings. OBERON: NCT05166889; TITANIA: NCT05158387; MIRANDA: NCT06040086; PROSPERO: NCT05742802."

Clinical protocol • Journal • P3 data • Chronic Obstructive Pulmonary Disease • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • IL33

TILIA: Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen (clinicaltrials.gov) - P3 | N=3527 | Recruiting | Sponsor: AstraZeneca | Trial completion date: Jun 2026 ➔ Nov 2027 | Trial primary completion date: Jun 2026 ➔ Nov 2027

Trial completion date • Trial primary completion date • Infectious Disease • Respiratory Diseases

COMETA: A Study to Investigate Efficacy and Safety of Tozorakimab Injections Compared With Placebo in Adult Participants With Symptomatic Chronic Obstructive Pulmonary Disease (COPD) With a History of COPD Exacerbations and Elevated Eosinophils (clinicaltrials.gov) - P2 | N=98 | Completed | Sponsor: AstraZeneca | Active, not recruiting ➔ Completed

Trial completion • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Long-term Efficacy and Safety of Tozorakimab in Participants With Chronic Obstructive Pulmonary Disease With a History of Exacerbations (PROSPERO). (clinicaltrials.gov) - P3 | N=1713 | Completed | Sponsor: AstraZeneca | Recruiting ➔ Completed

Trial completion • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases