Regeneron And Sanofi’s Itepekimab Shows Promise In COPD Trial, Mixed Results In Second Study

Regeneron Pharmaceuticals, Inc. and Sanofi announced that the Phase 3 AERIFY-1 trial evaluating itepekimab in former smokers with inadequately controlled chronic obstructive pulmonary disease (COPD) met its primary endpoint. The trial showed a 27% reduction in moderate or severe COPD exacerbations at week 52, demonstrating a clinically meaningful benefit. However, the companion AERIFY-2 trial did not meet the same primary endpoint, though some early improvement was observed.

“COPD is a particularly complex disease, and novel approaches are needed to address the multiple underlying biological disease drivers. We are proud of our work in this challenging treatment landscape, bringing Dupixent – the first-ever biologic medicine for COPD – to certain patients who previously had very limited options remaining. We are encouraged by the overall results from AERIFY-1 and the data through week 24 for AERIFY-2 and are reviewing the results from both itepekimab trials to inform next steps. We remain committed to our broader itepekimab development program and learnings from the AERIFY program will be invaluable as we continue to advance itepekimab in respiratory diseases with unmet need,” said George D. Yancopoulos, M.D., Ph.D., Board co-Chair, President and Chief Scientific Officer at Regeneron. 

In both trials, patients received itepekimab every two or four weeks alongside standard COPD therapy (either inhaled double or triple therapy). Formal statistical significance was achieved in AERIFY-1 for both dosing regimens, but not in AERIFY-2. Lower-than-expected exacerbation rates, possibly due to COVID–19–era enrollment, may have reduced the power to detect significant differences in both trials.

“While we are encouraged by the results of AERIFY-1, the results of both studies merit further exploration to have a full understanding of the data and the role that IL-33 plays in this complex disease. Certain people with COPD are in desperate need of new treatment options, especially those who continue to experience exacerbations despite being on maximal therapy, and we remain committed to discussing these data with regulatory agencies to evaluate our path forward,” said Houman Ashrafian, M.D., Ph.D., Executive Vice President, Head of Research and Development at Sanofi. 

The safety profile of itepekimab was consistent with previous studies, with adverse event rates comparable between treatment and placebo groups. Rates of serious infections and deaths were also similar. Regeneron and Sanofi plan to consult regulatory authorities to determine next steps. Itepekimab is still investigational and is also being studied in other inflammatory airway conditions such as chronic rhinosinusitis and non-cystic fibrosis bronchiectasis.