Cendakimab Shows Durable Efficacy in Phase 3 Trial for Eosinophilic Esophagitis
核心洞察
Phase 3 trial data reveals cendakimab's durable safety and efficacy in treating eosinophilic esophagitis (搜索) (EoE) in adults and adolescents over 48 weeks.
Cendakimab significantly improved dysphagia symptoms and reduced esophageal eosinophil counts compared to placebo at both 24 and 48 weeks.
The study enrolled patients aged 12-75 with EoE who had persistent dysphagia despite proton pump inhibitor treatment.
A Phase 3 study of cendakimab has demonstrated sustained efficacy and safety in treating eosinophilic esophagitis (搜索) (EoE) in adult and adolescent patients over a 48-week period. The findings, presented at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting, indicate that cendakimab, a monoclonal antibody targeting interleukin-13 (IL-13 (搜索)), offers significant improvements in both symptoms and esophageal eosinophil counts compared to placebo.
Rising Prevalence of EoE
Evan Dellon, MD, MPH, director of the Center for Esophageal Diseases and Swallowing at the University of North Carolina Chapel Hill (搜索), noted the increasing prevalence of EoE. "The burden of EoE has really increased pretty rapidly over the last several decades," Dellon stated, citing recent epidemiologic data presented at the ACG meeting showing a prevalence of approximately 1 in 700, a quadrupling over the last 10 years.
Cendakimab Mechanism and Study Design
Cendakimab is a recombinant, humanized, high-affinity, neutralizing monoclonal antibody that targets interleukin (IL)-13, inhibiting its binding to receptors IL-13Rα1/Rα2. The Phase 3 trial enrolled 430 patients aged 12–75 years with EoE, characterized by more than 4 dysphagia days over the 14-day period prior to day 1 and a lack of complete response to at least 8 weeks of proton pump inhibitor treatment. Patients were randomized in a 1:1:1 ratio to receive cendakimab 360 mg once weekly for 48 weeks, cendakimab 360 mg once weekly for 24 weeks followed by cendakimab 360 mg every other week for 24 weeks, or placebo once weekly for 48 weeks.
Key Efficacy Outcomes
The study's co-primary endpoints included the change in dysphagia days from baseline to week 24 and eosinophil histologic response (<6/hpf) at week 24. Patients receiving cendakimab once weekly showed significant improvements in both endpoints compared to placebo. Furthermore, at week 48, both cendakimab dosing regimens demonstrated efficacy in secondary endpoints versus placebo.
Expert Commentary
"When you balance the good efficacy across all of these outcomes and the safety, I think it's very promising results for a phase 3 trial," Dellon commented. "This is great to have positive phase 3 data from another study in EoE. I think for providers and patients, it's an exciting time because we're seeing the development of a lot of therapeutics. We're seeing things come into practice and be approved, and ultimately seeing the impact on patients' health."