Amgen Showcases New COPD, Asthma, Vasculitis Research at ATS 2024

Amgen, a biopharmaceutical company, announced the presentation of new respiratory research at the American Thoracic Society (ATS) 2024 International Conference set for May 12-22 in San Diego. Thirteen abstracts discussing two approved drugs and one investigational therapy will be showcased.

Jay Bradner, M.D., Amgen's executive vice president of Research and Development and chief scientific officer, expressed anticipation for presenting data from the Phase 2a COURSE trial for Tezspire® (tezepelumab-ekko) in treating chronic obstructive pulmonary disease (COPD), and the Phase 1 trial of AMG104/AZD8630, an inhaled anti-TSLP therapy for asthma. These efforts highlight Amgen's dedication to advancing respiratory disease treatments with limited current options.

The COURSE trial, which will be presented during the Clinical Trials Symposium, is a proof-of-concept Phase 2a study that evaluates the safety and efficacy of Tezspire in patients with moderate to very severe COPD. This study considers various patient demographics and health statuses, including inflammatory drivers, blood eosinophil count (BEC), emphysema, chronic bronchitis, and smoking status.

Additionally, new data from the Phase 1 study of AMG104/AZD8630, an investigational inhaled anti-TSLP therapy for patients with difficult-to-control asthma, will be presented. Meanwhile, a post-hoc analysis from the Phase 3 ADVOCATE trial will reveal insights into TAVNEOS® (avacopan) for patients with severe active ANCA-associated vasculitis, focusing on those with lung involvement.

The conference will include detailed presentations and poster sessions covering the efficacy and safety of Tezspire in COPD and asthma. Highlights include:
- Scientific and poster discussion sessions on Tezspire's effectiveness in COPD and severe asthma.
- An analysis of Tezspire's impact on nasal polyps in severe asthma patients.
- Initial findings from a Phase 4 study on Tezspire's effectiveness and safety across diverse racial and clinical groups.
- Reviews of biological treatments and their influence on asthma exacerbations requiring hospitalization.
- An evaluation of Tezspire’s efficacy among Black or African American patients and its effect on exercise tolerance.
- Data on early claims related to Tezspire treatment patterns in the U.S.
- Insights into asthma exacerbation rates in relation to biomarkers following Tezspire treatment.

For AMG104/AZD8630, presentations will address its Phase 1 safety and efficacy in patients with moderate to severe asthma on medium to high doses of inhaled corticosteroids and long-acting beta-agonists.

Regarding TAVNEOS, a post-hoc analysis from the ADVOCATE trial will compare its efficacy and safety against a prednisone taper in patients with ANCA-associated vasculitis with lung involvement.

Tezspire is a first-in-class human monoclonal antibody targeting the airway epithelium, the initial contact point for viruses and allergens. It blocks thymic stromal lymphopoietin (TSLP), reducing inflammation at its source and potentially benefiting a broad population with severe asthma. Tezspire is also being investigated for other conditions like COPD and chronic rhinosinusitis with nasal polyps.

Amgen’s collaboration with AstraZeneca involves developing and commercializing Tezspire and AMG104/AZD8630. This partnership aims to enhance respiratory disease treatments through shared expertise and resources.

TAVNEOS, an FDA-approved adjunctive treatment for ANCA-associated vasculitis, is a small molecule that targets the complement 5a receptor (C5aR). This action aims to reduce inflammatory cell damage linked to vasculitis. However, it is essential to monitor patients for potential serious side effects, including hepatotoxicity and infections.

Amgen remains committed to innovation in biotechnology, focusing on treatments for various tough diseases. The company was recognized in 2024 for its innovation and as a top employer, reflecting its significant impact on the healthcare industry.