Regeneron Dupixent Phase 4 Trial Shows 59% Histological Remission
REGN•Regeneron reported that its Phase 4 Dupixent trial in 69 adults with eosinophilic esophagitis achieved a 59% histological remission rate versus 4% for placebo and a 1.28 mm improvement in esophageal distensibility (p<0.05). The study also showed a 4.89-point reduction in abnormal endoscopic findings (p<0.0001) with no serious adverse events reported.
1. Phase 4 Trial Design and Results
The REMODEL trial enrolled 69 adults with eosinophilic esophagitis, comparing weekly 300 mg Dupixent dosing to placebo over 24 weeks. The primary endpoint of a 1.28 mm increase in esophageal distensibility versus a slight decline in the placebo arm was met (p<0.05), alongside a 4.89-point reduction in abnormal endoscopic findings (p<0.0001). Histological remission occurred in 59% of treated patients compared to 4% in placebo, and safety was consistent with Dupixent’s known profile with no serious adverse events.
2. Commercial and Market Implications
These Phase 4 results reinforce Dupixent’s status as the only approved biologic for eosinophilic esophagitis, potentially boosting physician adoption and long-term sales. The high remission rates and structural improvements may solidify Regeneron’s competitive advantage against emerging treatments, while the ongoing extension through week 128 will further inform the drug’s durability and commercial trajectory.
