Regeneron, Sanofi COPD Trial Delivers Mixed Results for Itepekimab
TARRYTOWN, N.Y. and PARIS – May 30, 2025 – In a setback for the potential of itepekimab in chronic obstructive pulmonary disease (COPD), Regeneron and Sanofi today announced topline results from their Phase 3 AERIFY trials. While AERIFY-1 met its primary endpoint, demonstrating a statistically significant reduction in moderate or severe exacerbations in former smokers, AERIFY-2 missed the mark. The contrasting outcomes present a nuanced picture for the drug’s future, leaving some uncertainty for investors.
AERIFY-1, designed to evaluate itepekimab in former smokers with inadequately controlled COPD, showed promising results. The trial met its primary endpoint with a 27% reduction in moderate or severe acute exacerbations at week 52 compared to placebo, a clinically meaningful benefit. This suggests that the drug could offer a new approach for this patient population. However, AERIFY-2, a second study within the Phase 3 program, failed to replicate the success, even though some early signals of benefit were observed.
Across both trials, patients were randomized to receive itepekimab in varying doses, either every two or four weeks, alongside standard COPD therapy. The primary goal was to assess the impact of itepekimab on the frequency of moderate or severe exacerbations. The results are summarized as follows:
| AERIFY-1 | AERIFY-2 | ||||||
| Week 24 | Week 52 | Week 24 | Week 52 | ||||
| Itepekimab every two weeks |
30% | 27%a | 18% | 2% | |||
| Itepekimab every four weeks |
34% | 21%a | 21% | 12% | |||
a Formal significance testing was only performed at 52 weeks in the Phase 3 trials, with significance achieved for both the every-two-week arm and every-four-week arm in AERIFY-1.
The total number of exacerbations was lower than anticipated due to the enrollment during the global COVID-19 pandemic which may have affected the power of both trials.
The safety profile of itepekimab, however, appeared consistent across both AERIFY trials. The adverse events were generally comparable between the treatment and placebo groups. Serious infections were observed, but the rates were within expected ranges and did not raise significant safety concerns. Adverse events resulting in death were also observed, though the rates were similar for itepekimab and placebo.
George D. Yancopoulos, M.D., Ph.D., Board co-Chair, President and Chief Scientific Officer at Regeneron, noted that the COPD treatment landscape is complex, and that the company is “encouraged by the overall results from AERIFY-1 and the data through week 24 for AERIFY-2.” He also added that the company will review the full results to determine the future steps.
Sanofi echoed these sentiments. Houman Ashrafian, M.D., Ph.D., Executive Vice President, Head of Research and Development at Sanofi, highlighted the importance of exploring the data further, acknowledging the unmet needs of severe COPD patients and the company’s commitment to discussing the data with regulatory agencies.
Detailed findings from these trials will be shared at an upcoming medical conference. The drug is currently being investigated in additional trials for other respiratory conditions.
The itepekimab COPD trial program included AERIFY-1 and AERIFY-2, which enrolled a combined 2,080 adults aged 40-85 years. These patients were former smokers with moderate-to-severe COPD. Former smokers were defined as those who have not smoked for at least six months. The primary aim of both trials was to measure the annual rate of acute moderate or severe COPD exacerbations. Moderate exacerbations were categorized as those necessitating systemic steroids and/or antibiotics, while severe exacerbations included hospitalization, emergency department or urgent care visits exceeding 24 hours, or death.
Itepekimab, developed through Regeneron’s VelocImmune technology, is a fully human monoclonal antibody targeting interleukin-33 (IL-33). IL-33 is believed to play a significant role in inflammation within the lungs of former smokers, and itepekimab aims to inhibit its activity.
Regeneron and Sanofi’s collaboration agreement covers itepekimab’s development and is currently being tested in Phase 3 trials for chronic rhinosinusitis with nasal polyps, non-cystic fibrosis bronchiectasis, and chronic rhinosinusitis without nasal polyps.
The mixed results raise questions about the drug’s ultimate potential to treat COPD. Investors will be eager to see the full data from these trials, as the industry looks for new treatments in a challenging market.
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