A Clinical Study of Latiglutenase as a Treatment for Symptom Reduction for Celiac Disease

Project Narrative This work will provide refined trial design, outcome measurement development, statistical tools, etc. (SBIR Phase I) to inform us on an optimal clinical trial design to demonstrate latiglutenase as a therapeutic solution for symptomatic treatment of celiac disease (CD) patients (SBIR Phase II). The primary endpoint will be statistically significant symptomatic improvement relative to placebo for seropositive CD patients as measured using a validated patient-reported outcome (PRO) instrument.