Roche’s Astegolimab Shows Mixed COPD Trial Results, Future Uncertain

Roche’s investigational monoclonal antibody astegolimab demonstrated mixed results in clinical trials for chronic obstructive pulmonary disease (COPD). While the Phase IIb ALIENTO trial showed a significant 15.4% reduction in annualised exacerbation rate (AER) over 52 weeks, the Phase III ARNASA study failed to reach statistical significance, with a 14.5% reduction. Both studies used biweekly dosing and standard of care therapies. Roche cited fewer-than-expected exacerbations and consistent secondary endpoints. No new safety issues emerged. Discussions with regulators are underway to determine astegolimab’s future. Astegolimab targets the ST2 receptor, blocking IL-33 signalling, and was licensed from Amgen in 2016. Meanwhile, the biologics race in COPD is intensifying. Regeneron/Sanofi’s Dupixent (IL-4/IL-13 blocker) and GSK’s Nucala (IL-5 inhibitor) have received FDA approval. AstraZeneca’s IL-33 blocker tozorakimab failed in Phase II. With the COPD biologics market expected to grow from $11.6B in 2023 to $30.2B in 2033, Roche faces increasing pressure to advance astegolimab.

22-07-2025