ImmunogenX, a clinical stage biotherapeutics company, has published the results of their phase 2 trial testing latiglutenase—an orally administered treatment for celiac disease (CD). Latiglutenase was shown to be safe and effective in reducing the symptoms of seropositive celiac disease patients on a gluten-free diet. A significant improvement in both symptom severity and quality of life was seen for seropositive patients, whose blood shows antibodies for celiac disease, but not for seronegative patients, who lack the blood markers for celiac disease but still exhibit intestinal damage and have one or more of the HLA genes for celiac disease.
398 patients completed the 12-week study, taking either an oral dose of latiglutenase or a placebo three times a day. Patients responded to a daily symptom diary and multiple quality of life questionnaires at weeks 0, 6 and 12. Seropositive celiac disease patients experienced a decrease in abdominal pain, bloating, tiredness, and constipation. More symptomatic patients experienced a greater reduction in these symptoms. Symptoms of nausea and diarrhea, however, were not significantly improved.
In patients receiving 900 mg of latiglutenase, symptoms at week 12 showed improvements of 58% for abdominal pain, 44% for bloating, 21% for tiredness, and 104% for constipation. Similar results were observed for quality of life outcomes. Dr. Peter H.R. Green, co-author of this study and Celiac Disease Foundation Medical Advisory Board member states, “The results showing symptom and quality of life benefit in seropositive CD patients due to latiglutenase are very encouraging and give us hope that a therapy to help celiac patients struggling from gluten-induced symptoms may be achievable soon.”
There is an urgent need for non-dietary treatments for celiac disease. While these study results do not show conclusive evidence that latiglutenase caused mucosal healing, they do show that latiglutenase reduced key symptoms for seropositive celiac disease patients on a gluten-free diet, making this a potentially promising future celiac disease treatment.
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