Phase 3 of Celiac Drug Research Abandoned

celiac study cancelledNumber of patients needed to clearly see a significant clinical outcome between placebo and the study drug is simply too large to continue.

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9 Meters Biopharma’s celiac disease drug isn’t measuring up in a phase 3 trial. After an interim analysis found that the study needs an enrollment count that is too large to support continuation, the company is scouring data on sub-groups to see if the therapy may have a treatment effect.

Larazotide, dubbed CedLara, aims to relieve persistent celiac disease symptoms for patients who follow a gluten-free diet. No treatments currently exist for individuals with the autoimmune condition, which is a reaction to eating gluten, besides avoiding gluten.

9 Meters set out to enroll 525 patients in the phase 3 trial to determine the effect of larazotide on celiac disease severity. The company conducted an interim analysis with 50% of the expected patients enrolled to determine the appropriate treatment group size to detect a statistically significant effect.

  • That analysis, conducted by an independent statistician, concluded that the additional number of patients needed to clearly see a significant clinical outcome between placebo and the study drug is too large to keep going, according to a June 21 news release.

After sharing the news Tuesday morning, 9 Meters’ stock slid by 47% midday, settling around 25 cents per share. The clinical-stage biotech is now determining if any subgroup of patients and/or symptoms were responsive to treatment.

“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,” said Patrick Griffin, M.D., chief medical officer for 9 Meters. “Completion of the analyses and engagement with FDA will determine further plans for larazotide for the treatment of celiac disease.”

9 Meters previously found in a phase 2 trial that larazotide reduced symptoms in celiac disease patients who had been on a gluten-free diet for at least 12 months.

Now, the Raleigh, North Carolina-based company is shifting gears to focus on vurolenatide, a repeated injection aimed at increasing nutrient absorption in patients with short bowel syndrome. Phase 2 results should be unveiled soon.

Depending on the final analysis findings for the larazotide trial, financial and human resources previously dedicated to the celiac disease drug will be reassigned to advance vurolenatide and the company’s early-stage product candidates, according to President and CEO John Temperato.