Four potential drugs to treat celiac disease have currently entered clinical studies. Two have moved into phase 2 and 3 trials to test their effectiveness in patients with celiac disease, and researchers need volunteers to proceed at this level.
None of these therapies would cure celiac disease. Most would only protect patients from small amounts of gluten, such as cross-contamination in restaurants. Each of the four uses a different mechanism.
Volunteers still needed
Alvine Pharmaceuticals is testing ALV003, an enzyme that breaks down gluten before the immune system has a chance to react to it. The company is recruiting volunteers for its study in the United States, Canada, Finland and Norway. Visit CeliActionStudy.com to volunteer or for more information about the study.
Alba Therapeutics’ larazotide acetate could help close junctions between cells in the intestine, preventing leaky gut syndrome and inflammation. In February the company announced positive results from phase 2 trials for effectiveness. This drug is the closest to becoming commercially available. The company is soon expected to move forward with the last phase before approval but is not yet recruiting volunteers.
Two other drugs, BioLineRx’s BL-7010 and ImmusanT’s Nexvax2 , are in early stages of testing low doses for safety in small human study groups.
BioLineRx is testing BL-7010, which binds the gluten protein and allows it to pass through the digestive system without causing any harm. It would only protect against small amounts of gluten. The study has been recruiting volunteers in Finland.
ImmusanT’s Nexvax2 is designed to induce immune tolerance. Patients could stop following the gluten-free diet as long as they took the drug. It would work only for patients with a certain genetic marker for celiac disease, DQ2. No clinical trial is open at this time.
Celiac disease and diabetes
Another clinical trial investigating a connection between celiac disease and type 1 diabetes is currently underway through the Hospital for Sick Children in Toronto, Canada. It is recruiting volunteers between ages 8 and 45 who have type 1 diabetes and have not been diagnosed with celiac disease. Initial screening will identify patients with asymptomatic celiac disease, determining eligibility for a dietary intervention study. Visit CeliacAndDiabetes.com for information.
Up-to-date information on studies needing volunteers can be found on ClinicalTrials.gov.
Van Waffle is the research editor for Gluten-Free Living. Study Sessions, his column on studies related to celiac disease and gluten sensitivity, appears in each issue.