A potential new treatment for COPD in former smokers missed the mark in one of two phase 3 trials, AERIFY-1/2, published in ERJ Open Research.
Drugmakers Sanofi and Regeneron reported in a press release that itepekimab met the primary endpoint in the AERIFY-1 study of a statistically significant reduction in moderate to severe exacerbations in former smokers regardless of eosinophilic phenotype. However, in a second phase 3 study, AERIFY-2, the same endpoint was not met despite researchers seeing a benefit earlier in the study.
In the AERIFY-1 study, itepekimab showed a 27% reduction in exacerbations compared to a placebo after 52 weeks. Patients were randomized in groups that received the treatment every two weeks, every four weeks or a placebo.
Houman Ashrafian, MD, PhD, executive vice president and head of research and development at Sanofi, said the company recognizes further research is needed.
“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 IL33 plays in this complex disease,” he said. “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.”
The safety profile of itepekimab was consistent across both trials. The companies said they are reviewing the data and will discuss with regulatory authorities to evaluate the next steps.
George Yancopouls, MD, PhD, board co-chair, president and chief scientific officer at Regeneron, echoed Dr. Ashrafian’s comments, adding that both companies are committed to moving forward with itepekimab.
“We remain committed to our broader itepekimab development program. The learnings will be invaluable as we continue to advance itepekimab in respiratory diseases with an unmet need,” said Dr. Yancopouls.
Detailed results of the studies will be presented at a future medical meeting.
