A new celiac disease clinical trial is launching in March 2019. ImmunogenX, a California company focused on advancing research and therapies to aid in celiac disease management and diagnostics received funding from the National Institutes of Health (NIH) for the study, which is being conducted at the Mayo Clinic, Rochester, MN.

This clinical trial will test ImmunogenX’s drug candidate latiglutenase (IMGX003), which is made up of a combination of two gluten-specific enzymes that degrade gluten. The study will monitor how well latiglutenase relieves symptoms and prevents intestinal damage in people with celiac disease.

The clinical trial process, which all drugs must go through before they are available to patients, takes many years. We first wrote about latiglutenase, formerly known as ALV003, in 2011 when it was being developed by Alvine Pharmaceuticals and completed a successful Phase 2a clinical trialwhich forms the basis for the current trial. A follow-up study completed in 2015, called the CeliAction study (Phase 2b), was inconclusive about the effect of latiglutenase on intestinal healing because all groups, whether on placebo or latiglutenase, experienced improved intestinal health. Researchers hypothesized this was due to all groups following the gluten-free diet more carefully (trial effect). Notably, a subset of participants who still had TTG antibodies in their blood showed significantly fewer symptoms when given latiglutenase.

ImmunogenX acquired latiglutenase in 2016 (IMGX003) and is continuing its development. ImmunogenX was awarded this NIH grant in Fall 2017 to further study latiglutenase and a new diagnostic technology called CypCel, which is a minimally-invasive way to monitor intestinal health over time instead of an endoscopy and biopsy.

INFOGRAPHIC: How Drugs Move through the Clinical Trials Process

This new clinical trial will test latiglutenase compared to placebo in participants who are regularly consuming a specific amount of gluten. Intestinal biopsies will be collected from study participants at the beginning and end of the study to measure any change in their intestinal lining. Participants will also report their symptoms daily using the Celiac Disease Symptom Diary (CDSD^©).

In addition to studying the effects of latiglutenase, CypCel will be used in this study to measure the health of the small intestine prior to and after study treatment. The CypCel test involves taking a single dose of simvastatin, a widely used cholesterol-lowering drug. The concentration of simvastatin measured in a patient’s blood determines the health of the small intestine. A reduced simvastatin concentration is correlated with intestinal recovery. CypCel measures intestinal health without an endoscopy and biopsy and could help people with celiac disease and their doctors monitor the effectiveness of the gluten-free diet.

If latiglutenase is shown to be successful in this trial and in future trials, it would be used in conjunction with a gluten-free diet and would help protect people with celiac disease against inadvertent gluten exposure. Studies show that even while following a strict gluten-free diet, many people with celiac disease are still regularly exposed to gluten.

Celiac disease research studies such as this one can only be successful with participation. At the 2017 Beyond Celiac Research Symposium, celiac disease researchers emphasized that research will only move forward with the participation of people with celiac disease. Your participation in research – whether it is completing a survey, participating in a focus group, or joining a clinical trial – helps advance the celiac disease community towards a future of being able to eat without fear.

Beyond Celiac is working with ImmunogenX to recruit for this clinical trial as part of our commitment to helping accelerate research. If you are interested in participating, you can learn more and see if you qualify at CeliacShield.com. You can also learn more about the study at ClinicalTrials.gov.