Innovative Celiac Drug Moves Forward in FDA Approval Process

“No one wants to just survive with the disease – they want to thrive. That’s the goal. We want to give someone the ability to thrive.” – John Temperato, CEO, 9 Meters Biopharma

Larazotide, the first, and so far, only celiac treatment to reach the final stages of patient clinical trials, may be on track for FDA approval within the next couple of years.

The drug hit a milestone in August 2019 when it became the first celiac treatment administered to a Phase 3 clinical trial patient. The Phase 3 clinical trial is a promising sign for those seeking a new treatment option, said John Temperato, CEO of 9 Meters Biopharama, Inc.

“We know how life altering suffering daily from the disease can be. We want to do everything we can to work with patient groups to help them do better,” said Temperato, whose company is developing larazotide. “I often say that no one wants to just survive with the disease – they want to thrive. That’s the goal. We want to give someone the ability to thrive.”

About 1% of the population has celiac disease, a serious autoimmune disease where eating gluten leads to damage in the small intestine. When people with celiac disease eat gluten (a protein found in wheat), their body mounts an immune response that attacks the small intestine.

How does larazotide it work?

Larazotide is designed to be a “tight junction regulator,” which should help prevent an inflammatory response if a celiac patient ingests gluten. The disease disrupts how the gut works. Essentially, gluten causes an inflammatory response in the intestines that, over time, will damage the intestinal villi – tiny, finger-like projections found inside the small intestine. Several symptoms are associated with the disease including diarrhea, fatigue, depression and more. 

According to 9 Meters Biopharma, Inc., the oral therapy shows promise in reducing an inflammatory response by helping junctions in the gut to work properly. Specifically, the drug is expected to mitigate symptoms in those who are accidentally exposed to gluten or as an adjunct therapy for patients whose symptoms persist, even if they maintain a gluten-free diet

Will larazotide be available soon?

Larazotide’s Phase 3 clinical trial is expected to enroll between 600 to 700 patients. Data from the first half of the study could be ready by early 2021.

A Phase 3 trial is one of the final steps before a drug becomes publicly available. During a Phase 1 trial a treatment’s safety is considered. Phase 2 trials determine the effectiveness of a drug or treatment. Phase 3 trials evaluate how a medication under development compares to existing, already approved treatments. Currently, the only treatment for celiac disease is a strict gluten-free diet. 

The final step, Phase 4, occurs after FDA approval. It involves monitoring some patients to gather additional information about a drug’s long-term effects and efficacy.

Larazotide was initially developed by Innovative Biopharmaceuticals. After launching the Phase 3 trial, the company announced a merger with RDD Pharma back in October 2019. The North Carolina-based biotech firm’s focus was on developing innovative therapies for gastrointestinal disorders. Temperato had been RDD Pharma’s CEO before being tapped to lead the new company. 

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