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[Ad hoc announcement pursuant to Art. 53 LR] Roche provides update on astegolimab in chronic obstructive pulmonary disease
Roche announced topline results from the pivotal phase IIb ALIENTO and phase III ARNASA trials investigating astegolimab in people with moderate to very severe chronic obstructive pulmonary disease (COPD). The ALIENTO study met its primary endpoint, showing a statistically significant 15.4% reduction in the annualised exacerbation rate (AER) at 52 weeks when astegolimab was given every two weeks. However, the ARNASA study did not meet its primary endpoint, demonstrating a numerical 14.5% reduction in AER at 52 weeks. The studies included a broad population of former and current smokers, regardless of blood eosinophil count, who have a history of frequent exacerbations. The safety profile of astegolimab was consistent with previously reported data, with no new safety signals identified. Roche will discuss the data with regulatory authorities to evaluate next steps for astegolimab. Detailed results from ALIENTO and ARNASA will be shared at an upcoming medical meeting. Astegolimab is an investigational, fully human anti-ST2 monoclonal antibody designed to bind with high affinity to the ST2 receptor, thereby blocking the signalling of IL-33. The astegolimab COPD pivotal programme consists of two registrational studies, ALIENTO and ARNASA, which are double-blinded, placebo-controlled, multicentre studies. Roche is committed to discovering and developing medicines and diagnostics for improving and saving the lives of people around the world.