Home » Phase 3 Celiac Disease Drug Trial Halted

Phase 3 Celiac Disease Drug Trial Halted

June 21, 2022

PHILADELPHIA (June 21, 2022) – 9 Meters Biopharma announced today that they will discontinue larazotide acetate drug trials in celiac disease. Larazotide acetate was the first to enter into clinical trials more than 15 years ago, and in 2020 was the first to reach Phase 3. Beyond Celiac partnered with 9 Meters for patient recruitment for the current round of trials.

 

Today’s announcement is a disappointing development in the quest to find treatments and a cure for celiac disease, but nearly two dozen other drug trials continue, four of which are in Phase 2, and Beyond Celiac as a leader in clinical trial recruitment remains resolute in our goal for treatments or a cure by 2030. 

 

“There will always be setbacks and triumphs as we move toward effective therapies,” notes Alice Bast, Beyond Celiac CEO. “Science is moving ahead rapidly; new trials will be happening; and we are ready to help accelerate research. Because of the outstanding Beyond Celiac community and our Go Beyond Celiac registry, we’re all in this together to advance other therapies so that we will be able to eat without fear and live life to the fullest by 2030.”

 

From their press release, Patrick Griffin, MD, Chief Medical Officer of 9 Meters said,

“We were hopeful that this study of larazotide would lead to a treatment option for those with celiac disease but also fully recognize the challenges and complexities of the disease and the ability to effectively measure outcomes.” 

 

Currently, the only treatment for celiac disease is the gluten-free diet, which is challenging to follow, especially since cross-contact with gluten is difficult to eliminate. Additionally, some patients to continue to have symptoms even when they are following a strict gluten-free diet.

Larazotide acetate is designed to work by decreasing intestinal permeability and regulating tight junctions between intestinal cells. This so-called “leaky gut” is thought to be the gateway to many autoimmune diseases, including celiac disease. If successful, the drug would help restore the leaky junctions to a normal state.

 

Beyond Celiac is a leading partner in the recruitment of patients for celiac disease clinical trials as part of their mission to accelerate research for treatments and a cure by 2030. Read more about the story at www.beyondceliac.org/research/research-news/

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