The investigational monoclonal antibody cendakimab has shown promising results in treating eosinophilic esophagitis (EoE), a chronic inflammatory condition of the esophagus, according to a phase III clinical trial presented at the American College of Gastroenterology annual meeting in Philadelphia. The study demonstrated that cendakimab significantly reduced symptoms, including difficulty swallowing, and lowered esophageal eosinophil levels in patients over a 24-week period.
As reported by medpagetoday, the trial involved 430 patients, with those receiving cendakimab experiencing a significant reduction in dysphagia days compared to the placebo group. Specifically, patients treated with cendakimab reported an average reduction of 6.1 days of dysphagia, compared to a 4.2-day reduction in the placebo group. Additionally, 28.6% of patients in the cendakimab group achieved an eosinophil count of ≤6 per high-powered field, a key marker of histologic response, compared with just 2.2% in the placebo group.
These positive effects continued over a full year, and cendakimab was well tolerated, with no serious drug-related adverse events. “The positive response was notable, even among EoE patients who had previously not responded to proton pump inhibitors (PPIs) or steroids,” noted Dr. Amrit K. Kamboj of Cedars-Sinai Medical Center.
Participants in the study were aged 35-36 on average, with 63-77% male and approximately half using PPIs at baseline. Of the 430 patients, 286 were treated with varying dosages of cendakimab, while 144 received a placebo. Those continuing treatment to 48 weeks showed even greater improvements in secondary endpoints, with significantly fewer dysphagia days and marked reductions in esophageal inflammation, as measured by the Eosinophilic Esophagitis Endoscopic Reference Score.
Cendakimab’s impact extended across histologic and symptomatic measures, with treated patients showing substantial improvement in both daily symptom diaries and esophageal inflammation scores. The antibody, which targets interleukin-13 receptors, reduced the mean grade and stage scores for inflammation by 18.9 and 22.0 points, respectively, compared to a 0.7-point change in the placebo group.
Adverse events were similar across both groups, with the most common side effects being COVID-19, injection-site reactions, and mild upper respiratory infections. Notably, fewer than 3% of patients discontinued treatment due to adverse events.
While the findings are encouraging, Dr. Kamboj emphasized the need for further study to evaluate long-term outcomes. Cendakimab could offer a new treatment option for EoE patients, particularly those who have not found relief with existing therapies like PPIs, topical corticosteroids, or elimination diets.