Once Promising Celiac Drug Larazotide Looks Doomed After Disappointing Phase 3 Trial

Celiac.com 07/18/2022 - Currently, a gluten-free diet is the only treatment for people with celiac disease. A number of companies have been attempting to create treatments that reduce or eliminate celiac disease symptoms, mostly for patients on a gluten-free diet. 

Larazotide, whose clinical trial is dubbed "CedLara," is such a drug. It's designed to reduce persistent celiac disease symptoms for people on a gluten-free diet. 

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In an earlier phase 2 trial, Larazotide was shown to reduce celiac symptoms in patients who had been on a gluten-free diet for at least 12 months. Many were excited to see how it would do in a phase 3 trial. The answer, unless we get some better news from 9 Meters Biopharma, the company that has been developing it, is badly.

For the phase 3 trial, 9 Meters Biopharma set out to enroll 525 patients in the phase 3 trial to determine the effect of larazotide on celiac disease severity. To determine the number of people needed to measure a statistically significant effect, the company conducted an analysis with half of the expected patients enrolled. 

According to a company news release, their analysis showed that the additional number of patients needed to produce a significant clinical outcome between placebo and Larazotide is too large for the company to pursue.

Reading between the lines of the news release, it seems as though the the company might need far more test subject than originally estimated to show a statistically significant result. That means that, no matter how effective the drug was for some people, the company can't afford to test in large enough numbers to show that it's genuinely effective.

With the failure of Larazotide, 9 Meters Biopharma announced that it will be pivoting to the development of vurolenatide, a repeated injection aimed at increasing nutrient absorption in patients with short bowel syndrome. Phase 2 results should be unveiled soon.

The failure of Larazotide marks the latest addition to the growing graveyard of celiac disease drugs. As Larazotide has been touted since 2013, this failure is particularly disappointing.

To punctuate the ignoble end for a once hopeful drug, the company's CEO and president, John Temperato, says that financial and human resources from Larazotide will be reassigned to advance vurolenatide and the company’s early-stage product candidates, pending a review.

Read more at seekingalpha.com