Roche's COPD Drug Astegolimab Fails to Meet Primary Endpoint in Phase 3 Trial

Roche's ambitions for its chronic obstructive pulmonary disease (COPD) drug astegolimab have suffered a significant setback as the company announced that the anti-ST2 monoclonal antibody failed to meet its primary endpoint in a crucial phase 3 trial. This development casts doubt on the Swiss pharmaceutical giant's plans to submit the drug for regulatory approval later this year.

Phase 3 Trial Results

The phase 3 Arnasa study, involving 1,375 patients, failed to demonstrate a statistically significant reduction in the annualized rate of moderate and severe COPD exacerbations (AER) over a year of treatment. While the trial showed a 14.5% reduction in AER, it fell short of the study's primary endpoint.

This outcome contrasts with the results from the phase 2b Aliento trial, which included 1,301 former and current smokers with a history of frequent COPD exacerbations. The Aliento study met its goal, showing a statistically significant 15.4% reduction in AER.

Implications for Astegolimab's Future

Dr. Levi Garraway, Roche's Chief Medical Officer, stated, "This was the first set of studies in an 'all-comers' COPD population, and we will discuss these data with regulatory authorities to evaluate next steps for astegolimab." The company noted that the number of exacerbations was "lower than prospectively anticipated in both trials," which may have impacted the study outcomes.

The disappointing results from the Arnasa trial have disrupted Roche's plans to submit astegolimab for regulatory approval in the United States and Europe later this year. The company's next steps for the drug remain uncertain, pending discussions with regulatory authorities.

Broader Context in COPD Treatment Landscape

Astegolimab's setback follows a similar challenge faced by AstraZeneca last year when its IL-33 inhibitor, tozorakimab, failed to meet expectations in a phase 2 COPD study. Despite this, AstraZeneca has continued to pursue phase 3 studies for tozorakimab.

The COPD treatment landscape has seen recent progress with Sanofi and Regeneron's Dupixent becoming the first biologic approved for the respiratory condition. This approval highlights the ongoing efforts and challenges in developing effective treatments for COPD, a complex and prevalent respiratory disease.