Regeneron week: AERIFY-1 COPD results posted; new cenvacibart, alirocumab, cemiplimab trials filed

The busiest week of filings centers on a completed Phase 3 COPD trial with results posted, alongside several newly registered or amended studies involving Regeneron compounds.

• Results were posted for "AERIFY-1," a completed Phase 3 trial of itepekimab (SAR440340/REGN3500), an anti-IL-33 antibody, in moderate-to-severe COPD, sponsored by Sanofi with Regeneron as collaborator. The trial evaluated itepekimab against placebo on the annualized rate of acute moderate-or-severe COPD exacerbations in former smokers with moderate-to-severe COPD.¹ Enrollment reached 1127 participants.¹
• A not-yet-recruiting Phase 3 trial called "ROXI-DAISEN" will test cenvacibart (REGN7508), an anti-Factor XI antibody, against placebo for secondary stroke prevention. The study aims to find out whether cenvacibart can safely lower the risk of a repeat ischemic stroke or other clot-related events in people who recently had an ischemic stroke or a mini-stroke (TIA).² Enrollment is estimated at 6106 participants.²
• A second, not-yet-recruiting Phase 1 trial in healthy volunteers will compare two formulations of cenvacibart. The trial is being conducted in non-obese healthy participants to compare two different forms of cenvacibart, with the main goal of studying how the drug is absorbed, modified, and removed from the body.³ Enrollment is estimated at 80 participants.³
• An active, not-recruiting Phase 2 trial called "ASCEND-QW" is testing weekly dosing of alirocumab, an approved PCSK9 inhibitor, in adults with hypercholesterolemia. The study is designed to assess how safe and effective weekly alirocumab dosing is in this population.⁴ Enrollment reached 438 participants.⁴
• A recruiting Phase 2 trial of neoadjuvant chemotherapy with cemiplimab, with or without alirocumab, in stage 1B-3A non-small cell lung cancer, led by Duke University with Regeneron as collaborator, was amended. As of 7/20/2026, the study was changed from a two-arm design to a single arm receiving neoadjuvant chemotherapy, cemiplimab every 3 weeks for 3 cycles, and alirocumab every 4 weeks prior to surgery.⁵
• A recruiting feasibility trial continues to test cemiplimab with Quad Shot radiation in elderly or frail patients with locally advanced cutaneous squamous cell carcinoma of the head and neck, sponsored by Vanderbilt-Ingram Cancer Center with Regeneron as collaborator. Patients receive cemiplimab every 3 weeks for up to 8 doses and Quad Shot radiation, given as four treatments over two days, for up to 4 rounds.⁶