Medically reviewed by Onikepe Adegbola, MD, PhD
9 Meters Biopharma confirmed that it had collaborated with Celiac.com. Celiac.com works to support the clinical trial enrollment of the company’s drug larazotide. It mainly focuses to treat gluten sensitivity disease.
At present, the drug is undergoing late-stage trials to test its safety and efficacy. All adult patients who have a six-month history of celiac disease are tested at this stage.
9 Meters Biopharma is a clinical-stage company developing novel treatments for people with rare digestive diseases. The website Celiac.com offers news, information, and support to those who must follow a gluten-free diet because of celiac disease. This collaboration aims to further support the enrollment in the 9 Meters’ Phase 3 study, known as CeDLara, for the celiac disease drug larazotide.
The Need for New Drug
Celiac is an autoimmune disease involving the digestive system. Inflammatory response to dietary gluten can result in disease, resulting in severe and often life-altering abdominal pain. Celiac disease patients’ only therapeutic option is to adhere to a gluten-free diet. However, it is insufficient for asymptomatic living. No matter how hard one can try avoiding gluten, there is always an unintentional consumption of trace amounts of gluten.
Therefore, this Phase 3 therapy in development can be the most effective solution against celiac disease. The company is ready to launch a new drug, larazotide, which is a gut-restricted tight-junction regulator.
Why Is Celiac Disease Difficult To Treat?
Gluten triggers autoimmune disorders like celiac disease. Since it is a gluten-sensitive disorder, patients can only opt for a gluten-free diet. But this diet comes with several challenges.
Wheat, barley, rye, and other grains contain gluten. Hence following the diet is quite a daunting task.
Gluten intolerance or gluten sensitivity is not the same thing as celiac disease. Some people with gluten intolerance might show similar symptoms as Celiac disease. But they do not exhibit any immune response that damages the small intestine. Hence, there is no specific drug for Celiac disease so far.
Celiac disease occurs when the body overreacts to gluten and damages the small finger-like projections along the small intestinal wall. Small intestines can’t absorb nutrients from food if their villi are injured. This can eventually result in malnutrition, loss of bone density, miscarriage, and infertility.
Larazotide: The New Drug
Larazotide is designed to reduce the damaging effects of gluten by preventing it from leaving the digestive tract. It will mitigate the inflammation even when a small amount of gluten is consumed. A key goal of 9 Meters is to use larazotide alongside a gluten-free diet in adults with celiac disease. It will help them restore tight junctions between intestinal cells, minimize gliadin leakage, and, therefore, minimize symptoms.
We are excited to partner with 9 Meters to recruit participants for the Phase 3 study of larazotide and have been closely following its development. Scott Adams, CEO of Celiac.com, expressed hope that the results of this study will soon lead to the first FDA-approved prescription treatment for celiac disease. This collaboration will result in a new treatment option for celiac patients. A large percentage of people with celiac disease can go for the new drug and live life stress-free.
9 meters biopharma and Celiac.com announce collaboration to support clinical trial enrollment in 9 meter’s phase 3 study for celiac disease. Celiac.com. (2022, April 20). Retrieved May 3, 2022, from https://www.celiac.com/articles.html/9-meters-biopharma-and-celiaccom-announce-collaboration-to-support-clinical-trial-enrollment-in-9-meter%E2%80%99s-phase-3-study-for-celiac-disease-r5866/