- Regeneron (REGN, Financial) and Sanofi achieve mixed Phase 3 results for itepekimab in COPD trials.
- AERIFY-1 succeeded with a 27% reduction in exacerbations, while AERIFY-2 did not meet its primary endpoint.
- Regulatory path remains uncertain; companies plan to discuss next steps with authorities.
Regeneron Pharmaceuticals, Inc. (REGN) and Sanofi have reported mixed outcomes from their Phase 3 COPD trials, AERIFY-1 and AERIFY-2, assessing the efficacy of itepekimab in former smokers. The AERIFY-1 trial achieved its primary endpoint with a significant 27% reduction in moderate to severe exacerbations at 52 weeks, compared to placebo. However, AERIFY-2 did not reach the same primary endpoint, despite initial promising results.
Both trials involved two dosing schedules of itepekimab, administered every two weeks and every four weeks, alongside standard COPD therapies. The trials took place during the COVID-19 pandemic, which is believed to have affected enrollment and the exacerbation rates observed.
Safety outcomes for itepekimab were in line with prior trials, showing adverse events comparable to placebo groups. Notably, anti-drug antibodies were rare and did not seem to impact drug levels. The trials' outcomes suggest a challenging regulatory route, as typical approval processes often demand two successful Phase 3 trials.
Regeneron and Sanofi have announced intentions to review the data thoroughly and consult with regulatory bodies to determine the next steps. Despite the mixed findings, the companies remain committed to further investigating itepekimab for COPD and other respiratory conditions. Detailed trial results are to be presented at an upcoming medical conference.
