Amgen (NASDAQ: AMGN) has announced the unveiling of groundbreaking respiratory research at the American Thoracic Society (ATS) 2024 International Conference, scheduled from May 12 to May 22 in San Diego. The presentation will include thirteen abstracts supporting two approved medications and one investigational treatment.
Dr. Jay Bradner, Amgen’s Executive Vice President of Research and Development and Chief Scientific Officer, expressed anticipation regarding the presentation of promising data from the Phase 2a COURSE trial focusing on COPD with Tezspire and the Phase 1 investigational study of asthma with AMG104/AZD8630, an inhaled anti-TSLP therapy. He emphasized Amgen’s dedication to pioneering new treatments for respiratory conditions with limited therapeutic options.
The COURSE trial data, presented within the Clinical Trials Symposium, was a proof-of-concept Phase 2a study evaluating the safety and efficacy of Tezspire® (tezepelumab-ekko) in patients with moderate to very severe chronic obstructive pulmonary disease (COPD), regardless of inflammatory drivers, blood eosinophil count (BEC), emphysema, chronic bronchitis, and smoking status.
Key highlights from other research include late-breaking data from the Phase 1 study of AMG104/AZD8630, an investigational inhaled anti-TSLP therapy, being assessed in patients with poorly controlled asthma. Additionally, there will be a post-hoc analysis from the Phase 3 ADVOCATE trial, evaluating the efficacy and safety of TAVNEOS® (avacopan) in patients with severe active ANCA-associated vasculitis (GPA or MPA) with lung involvement.
Below are the abstracts and presentation times:
TEZSPIRE
- Tezepelumab in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD): Efficacy and Safety from the Phase 2a COURSE Study
- Clinical Responses to Tezepelumab in Patients with Severe, Uncontrolled Asthma and a History of Nasal Polyps from the NAVIGATOR Study
- A Phase 4, Single-Arm, Open-Label Study to Evaluate the Effectiveness and Safety of Tezepelumab in Patients with Severe Asthma, Including Underrepresented Racial and Clinical Groups: Initial Baseline Demographics and Clinical Characteristics from the PASSAGE Study
- Effect of Biologics on Biomarkers of Type 2 Inflammation in Asthma: A Review of the Literature
- Efficacy of Biologics for Reducing Exacerbations Requiring Hospitalization or an Emergency Department Visit in Patients with Moderate to Severe, Uncontrolled Asthma
- Efficacy of Tezepelumab in Black or African American Patients: A Pooled Analysis of the PATHWAY and NAVIGATOR Studies
- Effect of Tezepelumab on Exercise Tolerance in Patients with Severe, Uncontrolled Asthma from the NAVIGATOR Study
- Patient Characteristics and Treatment Patterns with Tezepelumab in the United States: An Early Claims Data Study
- Asthma Exacerbation Rates as a Function of Biomarker Levels 4 Weeks After Initiation of Tezepelumab Treatment: An Analysis of the NAVIGATOR Study
- Reduced Mucus Plugging with Tezepelumab is Spatially Associated with Reduced Air Trapping in a Broad Population of Patients with Moderate to Severe Asthma
SEVERE ASTHMA DISEASE BURDEN
- Greater Exacerbation Reductions with Earlier Biologic Initiation After Severe Asthma Onset: Results from the CHRONICLE Study
AMG104/AZD8630 (iTSLP)
- Phase 1 Safety and Efficacy of AZD8630/AMG104 Inhaled Anti-TSLP in Healthy Volunteers and Patients with Asthma on Medium-High Dose Inhaled Corticosteroid (ICS) and Long-Acting Beta-Agonist (LABA) with Elevated Baseline Fractional Exhaled Nitric Oxide (FeNO)
TAVNEOS
- Efficacy and Safety of Avacopan Versus Prednisone Taper in Patients with ANCA-Associated Vasculitis with Lung Involvement: A Post Hoc Analysis of the ADVOCATE Trial
