Roche's Astegolimab Fails to Meet Goal in COPD Trial, Offers Mixed Results in Another Study

Roche's experimental lung drug astegolimab showed mixed results in trials, with a 15.4% reduction in worsening of chronic obstructive pulmonary disease (COPD) in a phase 2b study but failing to meet its goal in another trial. The drugmaker will discuss the data with regulators to determine next steps. The COPD market is expected to be worth over $5 billion, with Merck acquiring Verona Pharma for $10 billion and Sanofi and GSK introducing new medicines.

Title: Roche's Astegolimab Shows Mixed Results in COPD Trials

Roche (SIX: RO, ROG; OTCQX: RHHBY) recently announced mixed results from clinical trials evaluating astegolimab, an investigational drug for chronic obstructive pulmonary disease (COPD). The company reported that the pivotal Phase IIb ALIENTO trial met its primary endpoint, showing a statistically significant 15.4% reduction in annualized exacerbation rate (AER) at 52 weeks. However, the Phase III ARNASA trial did not meet its primary endpoint, demonstrating a numerical 14.5% reduction in AER, which did not reach statistical significance [1].

The ALIENTO study enrolled 1,301 participants and was designed to test astegolimab's efficacy and safety in patients with moderate to very severe COPD. The drug was administered every two weeks, and the results showed a significant reduction in exacerbations compared to placebo. The ARNASA trial, with 1,375 participants, did not achieve the same level of significance, but it did show a numerical reduction in exacerbations. The overall number of exacerbations was lower than anticipated in both trials, and the safety profile of astegolimab remained consistent with previously reported data, with no new safety signals identified [2].

Roche's Chief Medical Officer and Head of Global Product Development, Levi Garraway, MD, PhD, commented on the results, stating, "While COPD remains the third leading cause of death worldwide, patients and families have limited treatment options for managing this debilitating and complex disease. 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" [3].

The COPD market is expected to be worth over $5 billion, with recent acquisitions and new medicines being introduced. Merck acquired Verona Pharma for $10 billion, and Sanofi and GSK are introducing new medicines to address the growing need for effective treatments [4].

References:
[1] https://www.nasdaq.com/articles/roche-announces-mixed-results-astegolimab-copd-trials
[2] https://www.stocktitan.net/news/RHHBY/ad-hoc-announcement-pursuant-to-art-53-lr-roche-provides-update-on-7ac9l5xkw9zv.html
[3] https://www.morningstar.com/news/business-wire/20250720149499/genentech-provides-update-on-astegolimab-in-chronic-obstructive-pulmonary-disease