Latiglutenase development continues with initial CeliacShield™ study results and ongoing Solutions for Celiac™ clinical study actively recruiting participants.
by Kate Avery, MPH, Director of Research and Patient Engagement
ImmunogenX, Inc. has been committed to studying latiglutenase as a potential treatment for celiac disease since they acquired the drug in 2016. In spring 2019, the company launched CeliacShield™, a Phase 2 gluten-challenge study that recently concluded. Initial analyses show participants who received latiglutenase experienced significant reductions in abdominal pain, bloating, and fatigue compared to participants on placebo.
Further results from the CeliacShield™ study will be published in the near future. Matt Dickason, ImmunogenX Chief Operating Officer states, “We are extremely pleased with the results of the CeliacShield™ trial and grateful to all those who were responsible for bringing it to a successful conclusion, especially all trial participants that persevered despite the challenges imposed by COVID-19.”
Latiglutenase is a combination of two enzymes that target and degrade gluten proteins in the stomach, rendering them inactive and therefore less likely to cause symptoms and damage to the small intestine in people with celiac disease. Latiglutenase is mixed with water and a flavor packet to produce a clear drink-based medication that is consumed with meals. It is designed to be used in conjunction with a gluten-free diet.
ImmunogenX is continuing its planned series of Phase 2 clinical trials designed to explore latiglutenase as a treatment for celiac disease in conjunction with the gluten-free diet. CeliacShield™ (IMGX003-NCCIH-1721, NCT03585478) was the first trial of this Phase 2 program. Following the success of CeliacShield™ is the ongoing Solutions for Celiac™ Study (IMGX003-NIAID-1821, NCT04243551), designed to monitor how well latiglutenase relieves symptoms and improves quality of life in people with celiac disease in both real-world and known gluten exposure situations. The Solutions for Celiac™ Study was temporarily paused during the peak of the COVID-19 pandemic in 2020. Last November, the trial restarted and is actively recruiting at 4 locations: the Mayo Clinic (Rochester, MN), Columbia University (New York, NY), and two private practice clinics in Chesterfield, MI, and Chattanooga, TN.
Participation in Solutions for Celiac™ involves 6 in-office visits over 26 weeks with no biopsies and no injections. Participants are asked to drink the study medication with each of their main meals. Though there is a placebo component, all participants will receive the active study medication during a portion of the study. Less than 5 times a month, participants are asked to eat a study-provided snack that is either gluten-free or gluten-containing. When the snack does contain gluten, it is equivalent to less than half a slice of bread.
This unique, new trial design is designed to mimic the typical amount of gluten people with celiac disease are accidentally exposed to while on a gluten-free diet. In previous clinical trials involving latiglutenase, a phenomenon known as a Hawthorne or Trial Effect was observed whereby participants changed their behavior and reduced the amount of accidental gluten consumption to which they were exposed. The study design of Solutions for Celiac™ purposefully compensates for such behavioral changes and is intended to potentially decrease or eliminate any influence they may have on study outcomes.
Solutions for Celiac™ is actively looking for participants and COVID-19 precautions are in place at all sites. Visit SolutionsforCeliac.com to learn more and to see if you qualify. Beyond Celiac is recruiting for this trial as part of our commitment to accelerating research.