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Revita duodenal mucosal resurfacing

Fractyl announces positive topline results from Revita-2 clinical trial

Successful completion of Fractyl’s first sham-controlled, multi-centre clinical trial of Revita DMR to support EU commercial launch and inform US pivotal clinical trial

Fractyl Laboratories has announced positive topline results from Revita-2, the first randomised, double-blind, sham-controlled, multi-centre clinical trial of Fractyl’s Revita DMR. Data from patients with type 2 diabetes (T2DM) with and without non-alcoholic fatty liver disease (NAFLD) show that Revita duodenal mucosal resurfacing (DMR), a minimally invasive, outpatient procedural therapy that resurfaces the duodenal mucosa, is safe and effective relative to a sham procedure. Full results from the Revita-2 trial are expected to be presented at an upcoming scientific meeting.

“With a 45-minute outpatient Revita DMR procedure, we saw remarkable and sustained improvements in lowering blood sugar, reducing liver fat, reducing weight, and improving insulin sensitivity markers for type 2 diabetes patients with and without NAFLD,” said Dr Harith Rajagopalan, co-founder and CEO of Fractyl. “This exceptional data will inform our US pivotal clinical trial and support our commercial launch in the European Union, and we look forward to presenting the data from the Revita-2 clinical trial later this year.”

T2DM and NAFLD/NASH are two of the most prevalent metabolic diseases and have reached epidemic levels in the US and around the world, affecting nearly a billion people. An estimated 18 million people in the US 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 level1. There are currently no FDA-approved treatments for NAFLD/NASH.

“Patients with type 2 diabetes suffer from many severe co-morbidities and are often struggling to manage their disease with multiple daily medications,” said Professor David Hopkins, Director of the Institute of Diabetes Endocrinology and Obesity, Kings Health Partners, London. “By targeting insulin resistance in the duodenum - the root cause of metabolic disease - a single Revita DMR procedure has considerable benefits and will become an important alternative to escalating drug treatment.”

Building on years of research about the gut’s critical role as a root cause of metabolic disease, the Revita DMR 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.

“Fractyl has developed an extraordinary endoscopy device and procedure that is the first to show disease modification for type 2 diabetes and NAFLD/NASH,” said Dr Jacques Bergman, professor of Gastrointestinal Endoscopy at Amsterdam UMC and principal investigator of the Revita-2 study. “The procedure is straightforward to learn and perform and has now been shown to be safe and effective in hundreds of patients.”

“Nonalcoholic fatty liver disease has become a major concern for healthcare providers, especially for those caring for patients who also have type 2 diabetes, which exacerbates the course of liver disease and makes managing diabetes more difficult,” explained Dr Juan Carlos Lopez-Talavera, chief medical officer of Fractyl. “The significant improvement in markers of insulin resistance along with glycemic and hepatic indices indicates that Revita DMR is positioned to be an important nonpharmacological treatment option to correct the course of these metabolic diseases. We want to thank our study investigators and especially the patients for completing this important clinical trial. Revita DMR is a breakthrough approach to type 2 diabetes, NAFLD/NASH, and other insulin-resistant metabolic diseases and can not only provide significant and sustained disease modification but also reduce the disease management burden and costs for patients and payers.”

A US clinical trial for Revita DMR is currently recruiting patients with T2DM at five sites. 

Reference

1. JAMA Internal Medicine, August 2019, doi:10.1001/jamainternmed.2019.2396

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