Policy & Regulation
Fractyl Touts Positive Topline Results in the Revita-2 Clinical Trial in Patients with Type 2 Diabetes and Nonalcoholic Fatty Liver Disease
12 September 2019 - - US-based Fractyl Laboratories Inc. (Fractyl), a specialist in translating new insights in gut biology into transformative therapies for patients with metabolic diseases, has received positive topline results from Revita-2, the first randomised, double-blind, sham-controlled, multicenter clinical trial of Fractyl's Revita DData from patients with type 2 diabetes with and without nonalcoholic fatty liver disease (NAFLD) show that Revita DMR, a minimally invasive, outpatient procedural therapy that resurfaces the duodenal mucosa, is safe and effective relative to a sham procedure, the company said.

Full results from the Revita-2 trial are expected to be presented at an upcoming scientific meeting.

T2D and NAFLD/NASH are two of the most prevalent metabolic diseases and have reached epidemic levels in the United States and around the world, affecting nearly a bn people.

An estimated 18m people in the United States have both conditions, which greatly increases their risk of negative health outcomes.

While there are an increasing number of pharmacological treatments for type 2 diabetes, these have not translated into meaningful improvement in treatment outcomes for the patient and at the population level.

There are currently no FDA-approved treatments for NAFLD/NASH.

Building on years of research about the gut's critical role as a root cause of metabolic disease, the Revita duodenal mucosal resurfacing procedure aims to reset key metabolic pathways, including insulin resistance, to prevent and even reverse metabolic disease progression.

This same-day, outpatient endoscopic procedure uses heat to resurface the lining of the upper intestine (duodenum) in a minimally invasive, outpatient procedure.

The therapy is designed to target the root cause of metabolic disease in the duodenum, leading to significant improvements in metabolic disease parameters, reduced need for medication usage, and greater patient satisfaction with their therapy.

A US clinical trial for Revita DMR is currently recruiting patients with T2D at five sites.

Fractyl Laboratories is a private biotechnology company based in Lexington, Mass. Fractyl is developing Revita DMR, a same-day, minimally invasive procedural therapy to treat highly prevalent metabolic diseases.

The Revita DMR procedure harnesses breakthrough insights in intestinal biology and leverages the body's inherent regenerative capacity to reverse insulin resistance and metabolic diseases.

Fractyl's approach aims to improve the health of patients with metabolic diseases with device-based interventions for patients and healthcare systems.

The Revita DMR System received a CE mark in the European Union in April 2016. It has been approved for investigational use by the Food and Drug Administration in the United States. The Revita DMR System may be available for investigational use in other regions.
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