ImmunogenX, a subsidiary of Immunogenics, has started enrollment of patients for a phase 2b clinical trial to evaluate Latiglutenase (IMGX003), its lead candidate for the treatment of celiac disease.
The mid-stage clinical trial, called Solutions for Celiac trial (NCT04243551) is funded by the US’ National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID) in the form of a grant to ImmunogenX.
It will be held at Columbia University in New York, Mayo Clinic in Rochester, Minnesota, and private practice sites located across the US.
Peter H.R. Green of Columbia University Celiac Disease Center, the Co-Investigator of the trial, said: “We are very pleased to have the opportunity to participate on a critical real-world trial focusing on the most vulnerable CD patients. The indication of symptom relief is at the root of their acute suffering when inadvertently exposed to gluten.”
The phase 2b clinical trial will test the safety and efficacy of Latiglutenase. Its objective is for the further validation of the results noted from a previous phase 2b trial called Celiaction.
The Celiaction trial delivered statistically and clinically significant improvement in symptom severity, frequency, and quality of life in patients with celiac disease who remained persistently seropositive to gluten-induced antibodies.
Latiglutenase has been designed to break down gluten in the stomach, thereby leading to a reduction of gluten-induced symptoms and improvement of quality of life in patients with celiac disease.
Matthew A. Dickason – COO, and Lead on ImmunogenX’s clinical programs 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 2 meeting with FDA en route to a final Phase 3 trial to make this therapy commercially available to the benefit of long-suffering CD patients.”