Biotherapeutics company ImmunogenX has commenced patient enrolment in a Phase IIb clinical trial of Latiglutenase (IMGX003) for the treatment of celiac disease.
IMGX003 is a drink-based investigational medicine designed to break down gluten in the stomach and decrease gluten-induced symptoms for improving the quality of life of patients.
The Solutions for Celiac Phase IIb trial will evaluate the safety and efficacy of the drug candidate in around 120 patients at Columbia University, Mayo Clinic and private practice sites in the US.
It has a multi-centre, prospective, randomised, double-blind, placebo-controlled, crossover design, where two potential treatment sequences will be randomly assigned.
The primary outcome is the mean percentage decrease in symptom severity compared to placebo, while secondary outcomes are health-related quality of life measured using four different surveys.
The study also aims to validate the data gathered in the prior Phase IIb Celiaction trial, which demonstrated a statistically and clinically significant improvement in symptom severity, frequency, and quality of life.
The new Phase IIb trial is funded by a grant from the National Institutes of Health (NIH)’s National Institute of Allergy and Infectious Diseases (NIAID).
ImmunogenX COO Matthew Dickason said: “This trial is the culmination of an enormous effort on the part of our team and we are excited about the prospects for success based on the positive outcomes from the previous Celiaction trial.
“We fully expect this trial to lead to an end-of-Phase II meeting with FDA en route to a final Phase III trial to make this therapy commercially available to the benefit of long-suffering CD patients.”
The company is also developing a diagnostic tool based on a clinically relevant metabolic marker compound for celiac disease management.