tozorakimab (MEDI3506) / AstraZeneca - LARVOL DELTA

Tozorakimab exerts distinct dual pharmacology to reduce COPD epithelial remodelling (ERS 2025) - No abstract available

Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

A phase 3 extension study evaluating long-term efficacy and safety of tozorakimab in COPD: PROSPERO study design (ERS 2025) - No abstract available

Clinical • P3 data • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Phase 3 studies evaluating the efficacy and safety of tozorakimab in COPD: OBERON and TITANIA study designs (ERS 2025) - No abstract available

Clinical • P3 data • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Safety Profile of Tozorakimab (an Anti-IL-33 Monoclonal Antibody): Data From the FRONTIER Phase 2 Program of 1076 Patients (ATS 2025) - P2, P3 | "Across all four FRONTIER studies, tozorakimab was well tolerated with no safety concerns identified. Several phase 3 studies are ongoing for tozorakimab in COPD (NCT05166889, NCT05158387, NCT06040086 and NCT05742802) and severe viral lower respiratory tract disease (NCT05624450)."

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

New data for Airsupra and Breztri highlight progress in advancing asthma and COPD care globally (AstraZeneca Press Release) - "AstraZeneca will present the latest clinical and real-world data across its leading inhaled, biologic and early science respiratory portfolio at the American Thoracic Society (ATS) International Conference, in San Francisco, CA from 16 to 21 May 2025...With more than 75 abstracts, including eight late-breakers, the Company continues to drive innovation and address unmet needs in care across all severities of asthma, chronic obstructive pulmonary disease (COPD), eosinophilic granulomatosis with polyangiitis (EGPA) and other chronic inflammatory diseases."

Clinical data • Asthma • Chronic Obstructive Pulmonary Disease • Chronic Rhinosinusitis With Nasal Polyps • Eosinophilic Granulomatosis With Polyangiitis • Inflammation

An Accessorised Prefilled Syringe to an Autoinjector Pharmacokinetic Bridging Study of Tozorakimab (clinicaltrials.gov) - P1 | N=252 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

Enrollment open

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 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Tozorakimab: Data from P2 UMBRIEL trial (NCT06932263) for uncontrolled asthma post 2026 (AstraZeneca) - Q1 2025 Results

P2 data • Asthma • Immunology

Umbriel: Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids (clinicaltrials.gov) - P2 | N=540 | Recruiting | Sponsor: AstraZeneca

New P2 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

OBERON: Efficacy and Safety of Tozorakimab in Symptomatic Chronic Obstructive Pulmonary Disease With a History of Exacerbations (clinicaltrials.gov) - P3 | N=1132 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting

Enrollment closed • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

TITANIA: Efficacy and Safety of Tozorakimab in Symptomatic Chronic Obstructive Pulmonary Disease With a History of Exacerbations. (clinicaltrials.gov) - P3 | N=1172 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting

Enrollment closed • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

An Accessorised Prefilled Syringe to an Autoinjector Pharmacokinetic Bridging Study of Tozorakimab (clinicaltrials.gov) - P1 | N=252 | Not yet recruiting | Sponsor: AstraZeneca

New P1 trial

A phase 2a trial of the IL-33 mAb tozorakimab in patients with COPD: FRONTIER-4. (PubMed, Eur Respir J) - P2 | "Although the primary endpoint was not met in the intent-to-treat population, tozorakimab showed positive efficacy signals versus placebo in a subgroup of patients with COPD with a high risk of exacerbations."

Clinical • Journal • P2a data • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases • IL33

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 | Not yet recruiting | Sponsor: AstraZeneca

New P2 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Umbriel: Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids (clinicaltrials.gov) - P2 | N=540 | Not yet recruiting | Sponsor: AstraZeneca

New P2 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

MIRANDA: Efficacy and Safety of Tozorakimab in Symptomatic Chronic Obstructive Pulmonary Disease With a History of Exacerbations (clinicaltrials.gov) - P3 | N=1240 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting | Trial completion date: Aug 2026 ➔ May 2026 | Trial primary completion date: Jun 2026 ➔ Mar 2026

Enrollment closed • Trial completion date • Trial primary completion date • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Tozorakimab: Data from P3 PROSPERO trial (NCT05742802) for COPD in 2026 (AstraZeneca) - Q4 & FY2024 Results: Data from P3 MIRANDA trial (NCT06040086) in adults with symptomatic COPD with a history of exacerbations in 2026

P3 data • Chronic Obstructive Pulmonary Disease

Tozorakimab: Data from P3 OBERON trial (NCT05166889) for COPD in 2026 (AstraZeneca) - Q4 & FY2024 Results: Data from P3 TITANIA trial (NCT05158387) for COPD in 2026

P3 data • Chronic Obstructive Pulmonary Disease

TILIA: Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen (clinicaltrials.gov) - P3 | N=2870 | Recruiting | Sponsor: AstraZeneca | Trial completion date: Mar 2025 ➔ Jun 2026 | Trial primary completion date: Mar 2025 ➔ Jun 2026

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

FRONTIER-4: a phase 2a study to investigate tozorakimab (anti-IL-33 mAb) in COPD (BTS WM 2024) - P2 | "Tozorakimab was well tolerated. Conclusion Tozorakimab may improve lung function and reduce COPD exacerbations, especially in patients with frequent exacerbation history."

P2a data • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases • IL33

Tozorakimab: Data from P3 OBERON trial (NCT05166889) for COPD post 2025 (AstraZeneca) - Q3 2024 Results: Data from P3 TITANIA trial (NCT05158387) for COPD post 2025

P3 data • Chronic Obstructive Pulmonary Disease • Immunology

FRONTIER-3: a randomized, phase 2a study to evaluate the efficacy and safety of tozorakimab (an anti-interleukin-33 monoclonal antibody) in early-onset asthma (BTS WM 2024) - P2 | "A trend towards greater numerical improvements was observed for the tozorakimab 600 mg dose compared with the 300 mg dose for several endpoints. View this table: View inline View popup Abstract S90 Table 1 Efficacy endpoints in the ITT population and patients with at least two exacerbations in previous 12 months"

Clinical • P2a data • Asthma • Immunology • Respiratory Diseases • IL33

Tozorakimab: Data from P3 PROSPERO trial (NCT05742802) for COPD post 2025 (AstraZeneca) - Q3 2024 Results: Data from P3 MIRANDA trial (NCT06040086) in adults with symptomatic COPD with a history of exacerbations post 2025

P3 data • Chronic Obstructive Pulmonary Disease • Immunology

Efficacy and safety of tozorakimab in moderate-to-severe atopic dermatitis: A Phase 2a randomized controlled trial (FRONTIER-2). (PubMed, J Eur Acad Dermatol Venereol) - P2 | "FRONTIER-2 did not show a statistically significant difference in the primary endpoint for tozorakimab compared with placebo. However, numerical increases in responder rates were observed."

Journal • P2a data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • Pruritus • IL33

Tozorakimab (anti-IL-33 mAb) reduces mucus plugging in COPD: an imaging sub-study in the FRONTIER-4 phase 2a COPD trial (BTS WM 2024) - P2, P3 | "Conclusion This exploratory study offers the first insights into the effect of tozorakimab on mucus plugging in COPD, using CT imaging. Ongoing phase 3 studies ( NCT05166889 , NCT05158387 , NCT06040086 ) provide further opportunity to investigate the effect of tozorakimab on mucus plugging and the impact on symptoms, quality of life and lung function."

P2a data • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases • IL33