By Fineline Cube 
Genentech, a member of the Roche Group (SWX: ROG, OTCMKTS: RHHBY), announced the results of two key clinical trials evaluating astegolimab in patients with moderate to severe chronic obstructive pulmonary disease (COPD). The Phase IIb ALIENTO study met its primary endpoint, demonstrating a statistically significant reduction in the annualized exacerbation rate (AER). However, the Phase III ARNASA study did not meet its primary endpoint.
Clinical Trial Outcomes
The ALIENTO trial enrolled 1,301 COPD patients and showed that astegolimab, administered once every two weeks, led to a statistically significant 15.4% reduction in AER over 52 weeks. In contrast, the ARNASA trial enrolled 1,375 patients and observed a 14.5% reduction in AER, which did not reach statistical significance.
Study Details
Both studies included current or former smokers with a history of frequent exacerbations, regardless of blood eosinophil count. All participants received standard maintenance therapy, including various combinations of inhaled corticosteroids (ICS), long-acting beta agonists (LABA), and long-acting muscarinic antagonists (LAMA). The total number of exacerbation events in both studies was lower than anticipated. The safety profile of astegolimab remained consistent with previous findings, with no new safety concerns identified.
Drug Mechanism
Astegolimab is an investigational fully human monoclonal antibody targeting the ST2 receptor. It is designed to bind ST2 with high affinity and block IL-33 signaling. Genentech plans to engage with regulatory authorities to discuss the findings and will present full results at upcoming medical conferences.-Fineline Info & Tech