The effect of AN-PEP protease on gluten exposure in the real life of celiac disease patients measured by stool gluten immunogenic peptides

STEFANOLO, J.P.; SEGURA, V.; GRIZZUTI, M.; COMINO, I.; COSTA, A.F.; PUEBLA, R.; TEMPRANO, M.P.; NIVELONI, S.; DE DIEGO, G.A.; OREGUI, M.E.; SMECUOL, E.; DE MARZI, M.C.; VERDÚ, E.F.; SOUZA, C.; BAI, J.C.

Chicago

Congreso; Digestive Disease Week®; 2023

Background/Aim: The gluten-free diet has limitations, and there is intense research in thedevelopment of adjuvant therapies. Our aim was to examine the effects of orallyadministered Aspergillus niger endopeptidase (AN-PEP) on inadvertent gluten exposureand symptom prevention in adult patients with celiac disease (CeD) following their usualgluten-free diet (GFD).Methods: This was an exploratory, double-blind, randomized, placebo-controlled trial thatenrolled patients with CeD on a long-term GFD. After a four-week run-in period, patientswere randomized to 4 weeks of 2 AN-PEP capsules (GliadinX. AVI Research LLC; USA)at each of 3 meals/day or placebo. Outcome endpoints were: 1- the average weekly stoolgluten immunogenic peptides (GIP) between the run-in and end of treatments, andbetween AN-PEP and placebo; 2) the Celiac Symptom Index (CSI); 3- CeD-specificserology; and 4- the quality of life. Stool samples were collected for GIP by ELISA everyTuesday and Friday during run-ins and treatments.Results: 40 patients were randomized to the intention-to-treat analysis, and three wereexcluded from the per-protocol assessment. Overall, 628/640 (98.1%) stool samples werecollected. GIP was undetectable (0.32µg/g) to potentially cause mucosal damage. Median GIP concentration in theAN-PEP arm was 44.7% lower than in the run-in period. One-third of patients exhibitingGIP >0.08 µg/g during run-in had lower or undetectable GIP after AN-PEP treatment.Compared with the run-in period, the proportion of symptomatic patients (CSI >38) in theAN-PEP arm was significantly lower (p