What the trial was testing
The ACeD enrolled 41 patients with celiac disease. The study was sponsored by Kanyos Bio and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was an early-stage trial — researchers are still confirming safety and getting an early look at how well the treatment works. Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
No dose-limiting safety issues across all five dose levels tested.
The Lancet Gastroenterology & Hepatology · 2023 · NCT04248855
These findings — that safety issues at any dose of KAN-101 in this first-in-human celiac trial — were published in the The Lancet Gastroenterology & Hepatology and represent the headline result of the study.
Researchers tracked outcomes across 41 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with celiac disease, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
KAN-101 is still in development and not yet FDA-approved. The only proven treatment for celiac disease today is a strict, lifelong gluten-free diet. Several drugs aimed at celiac disease are in clinical trials. Ask a gastroenterologist about open trials if a strict gluten-free diet is not enough.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open celiac disease trials
Direct to Patient Minimal Risk Biospecimen and Data Collection Research
This study aims to help researchers better understand health conditions and develop improved tests, treatments, and cures for diseases. Joined Bio collects health data, lifestyle information, biological samples, and feedback from participants and provides this to qualified research partners.
Liver Steatosis in Pediatric CD Patients
Celiac disease (CD) is an autoimmune enteropathy triggered by the intake of gluten, characterized by a genetic predisposition. Although, CD is often associated with malabsorption symptoms, a growing number of affected subjects are overweight or frankly obese. One of the conditions that is most frequently detected in pauci/asymptomatic subjects is an increase in transaminases, which often regresses completely after the start of GFD. More recently, a specific liver disorder has shown a certain relevance in adult patients suffering from CD, so much so that the European Society for the Study of Coeliac Disease (ESsCD) has cited it among the possible comorbidities which should be screened in CD subjects: Non-Alcoholic Fatty Liver Disease (NAFLD). In adults, a non-random association between CD and NAFLD has been demonstrated, showing a CD prevalence rate of 2-14% among patients with NAFLD. Few studies have focused on this same aspect in pediatric age, reporting contrasting data. Several factors have been advocated as putative responsible of association between CD and NAFLD: dietary imbalances, intestinal mucosa permeability impairment, alterations of the intestinal microbiota. The objectives of this study are: 1. define, retrospectively, the prevalence of NAFLD in a pediatric population affected by CD and study its possible association with GFD. 2. define the possible role of the intestinal permeability alteration and/or the intestinal mucosa damage and/or the proinflammatory status in the development of NAFLD in children affected by CD.