23 March 2021 - - The first patient has been enrolled in a pivotal clinical trial of Revita DMR for patients with type 2 diabetes, US-based life sciences company Fractyl Laboratories Inc said.

The trial, called REVITA-T2Di, will evaluate the ability of a single Revita DMR treatment to allow patients currently on insulin therapy but with inadequate glycemic control to achieve durable insulin-free glycemic control.

This pivotal trial is designed to form the basis for a marketing application to the US Food and Drug Administration.

REVITA-T2Di (NCT #04419779) is a prospective, randomized, double-blind, sham-controlled study that is expected to enroll more than 300 patients at up to 35 sites in the United States and Europe.

It will evaluate the efficacy of Revita DMR (duodenal mucosal resurfacing), a first-in-class intervention targeting the role of the intestine in metabolic disease.

The trial's primary endpoint is the percentage of patients who are able to achieve target glycemic control (HbA1c less than or equal to 7%) without the need for insulin at 24 weeks, comparing Revita DMR to the sham arm.

The trial has begun enrolling patients at its first clinical site at Indiana University Health, and additional trial sites will be announced in the coming months.

Revita DMR is based on Fractyl's breakthrough insights surrounding the role of the gut in metabolic diseases.

An outpatient endoscopic procedure, Revita DMR resurfaces the lining of the upper intestine (duodenal mucosa). Revita DMR has been studied in clinical trials involving close to 300 patients.

In April 2016, the Revita DMR System received a CE mark in the European Union. In the United States, the device has not yet been authorized for marketing, but is the subject of an FDA-approved Investigational Device Exemption study. The Revita DMR System may be available for investigational use in other regions.

Fractyl is pioneering treatments for metabolic diseases based on revolutionary scientific insights into the root causes of metabolic dysfunction.

Fractyl's lead program is Revita DMR, an outpatient endoscopic procedural therapy designed to treat insulin resistance in type 2 diabetes.

The company's groundbreaking discoveries offer the potential to address other metabolic diseases in the future, including nonalcoholic fatty liver disease/nonalcoholic steatohepatitis (NAFLD/NASH), in an effort to reduce the global economic and healthcare burden of metabolic disease. Fractyl is a private biotechnology company based in Lexington, Mass.