US-based biotechnology firm Fractyl Laboratories has received the US Food and Drug Administration (FDA) approval to start an Investigational Device Exemption (IDE) study of Revita DMR (duodenal mucosal resurfacing) treatment.

The IDE trial, dubbed Revita T2Di, is a randomised, double-blind, sham-controlled study designed to enrol 300 type 2 diabetes (T2D) patients being treated with insulin, to evaluate the effect of Revita DMR on glycemic control and insulin requirements.

The primary endpoint of the study includes the percentage of patients who are able to achieve target glycemic control without the need for insulin at 24 weeks, comparing Revita DMR to the sham arm.

Fractyl chief medical officer Juan Carlos Lopez-Talavera said: “We are delighted the FDA has granted this IDE allowing Fractyl to begin a clinical study evaluating the ability of Revita DMR to not only improve glycemic (blood glucose) control but also eliminate or reduce insulin injections for patients with advanced type 2 diabetes.

“We are grateful for the close collaboration with our scientific advisors and the productive partnership with the FDA that has led to the design of this pivotal study that aims to address the challenges and burden of insulin therapy with the use of Revita DMR.”

Revita DMR is a minimally-invasive, outpatient, endoscopic procedure for diabetes patients

The Revita T2Di pivotal study is aimed at enrolling patients with inadequately controlled T2D even after taking oral drugs and insulin injections and adopting lifestyle changes.

Fractyl said that Revita is an advanced intervention that targets insulin resistance and metabolic disease progression by resetting pathways in the gut, which are crucial in driving metabolic disease.

The minimally-invasive, outpatient, endoscopic procedure is a non-drug and non-surgical alternative to enhance insulin sensitivity, bring down HbA1c, and reduce liver fat and to improve blood sugar control and fatty liver disease, said the company.

Fractyl co-founder and CEO Harith Rajagopalan said: “Having first developed the science around the role of the gut in metabolic diseases and then establishing the proof of concept of Revita DMR as a treatment with the potential to reverse metabolic diseases, this pivotal study is now poised to evaluate the role of Revita DMR in addressing a critical need for patients and health systems in managing type 2 diabetes.

“The clinical, economic, and patient burden of type 2 diabetes in society is already too large and growing too rapidly. Fractyl is committed to changing the trajectory of this disease for our patients and society. This pivotal study will be an important step in our journey toward developing and commercializing a therapy that has the potential to reverse the root cause of the disease.”