Fractyl eyes insulin resistance in fatty liver disease

Fractyl Laboratories presented data last week at the annual meeting of the American Assn. for the Study of Liver Diseases, touting its Revita duodenum mucosal resurfacing device in patients with metabolic diseases driven by insulin resistance, such as Type II diabetes and fatty liver disease.

The Lexington, Mass.-based company’s Revita DMR trans-oral procedure targets a part of the intestine called the duodenum. The duodenum is involved in regulating insulin sensitivity and maintaining metabolic homeostasis. The short, minimally invasive procedure uses balloon catheters to perform mucosal lift and hydrothermal ablation to alter gut signaling in patients suffering from metabolic diseases.

A 50-patient clinical trial is underway in patients with Type II diabetes at sites in the U.K., Chile, Italy, Holland and Belgium.

“Insulin resistance is a common metabolic driver of Type II diabetes, fatty liver disease and [nonalcoholic steatohepatitis],” Dr. Arun Sanyal, of the Virginia Commonwealth University School of Medicine, said in prepared remarks. “The ability of Revita DMR to significantly improve markers of insulin resistance along with glycemic and hepatic indices suggests an interesting method for changing the course of these metabolic diseases.”

One set of data presented at this year’s annual meeting reported on the first-in-human study of Revita DMR on a subcohort of patients with Type II diabetes. The study showed improvements in markers of insulin resistance, systemic inflammation and oxidative stress post-procedure, which suggests that Revita DMR may be used to correct hyperglycemia and address key drivers of fatty liver disease.

The second study evaluated patients with Type II diabetes from a composite of 2 clinical studies and a minimum follow-up of 6 month. Both studies showed that a single DMR procedure improved glycemic markers and markers of fatty liver disease.

“Understanding the relationship between insulin resistance and disease progression in patients with type 2 diabetes and liver disease is a primary goal for our team,” co-founder & CEO Dr. Harith Rajagopalan said in prepared remarks. “Our findings presented at The Liver Meeting today contribute to a growing body of evidence suggesting that Revita DMR may address the underlying metabolic complications of insulin resistance and could represent a new treatment option in patients with type 2 diabetes and fatty liver disease.”

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