Roche’s ambitions to submit its chronic obstructive pulmonary disease (COPD) candidate astegolimab for regulatory approval this year have hit a major hurdle. In a phase 3 trial failure, the anti-ST2 monoclonal antibody did not demonstrate a significant reduction in COPD flare-ups, dampening its prospects for 2025 approval.
The Swiss pharmaceutical company had tested astegolimab in two pivotal trials: the phase 2b Aliento study (1,301 patients) and the phase 3 Arnasa study (1,375 patients). Both trials focused on evaluating whether astegolimab could reduce the annual rate of moderate to severe COPD exacerbations (AER) over a one-year period among former and current smokers with frequent flare-ups.
While the Aliento trial achieved its primary endpoint with a 15.4% reduction in AER, the larger Arnasa study failed to meet its goal, falling short of the 14.5% threshold. Roche acknowledged that both studies observed fewer exacerbations than expected, potentially influencing the outcomes.
These two trials were critical milestones before Roche could proceed with regulatory filings in the U.S. and Europe, as outlined in the company’s April pipeline update. The company had not committed to a regulatory strategy for astegolimab following earlier uncertainty voiced in February.
“This is the first set of studies in the broader COPD population. We will now consult with regulatory agencies to determine the next steps for astegolimab,” said Levi Garraway, Roche’s Chief Medical Officer.
Astegolimab, licensed from Amgen, targets the interleukin-33 (IL-33)/ST2 pathway, a mechanism associated with airway inflammation. However, this pathway has proved elusive for drug developers. Roche had already abandoned attempts to develop astegolimab in asthma and COVID-related pneumonia by 2021 due to underwhelming data.
Other companies have faced similar setbacks. In 2024, AstraZeneca’s tozorakimab, which also blocks IL-33 signaling via ST2 and other pathways, failed a phase 2 COPD trial. Despite this, AstraZeneca has pressed on, with three phase 3 studies currently underway.
Meanwhile, the COPD treatment landscape saw a major development with the FDA approval of Dupixent (Sanofi/Regeneron), now the first biologic approved for COPD—raising the competitive stakes in this high-need therapeutic area.
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