Fractyl Laboratories said today that a clinical trial of its Revita DMR therapy for patients with Type 2 diabetes with and without nonalcoholic fatty liver disease (NAFLD) has produced positive results.
The Revita-2 trial was a randomized, double-blind, sham-controlled, multicentered study that showed the therapy is safe and effective relative to a sham procedure. Lexington, Mass.-based Fractyl Laboratories said it expects to release the study’s full results at an upcoming scientific meeting.
Revita DMR is a minimally invasive, outpatient procedural therapy designed to resurface the duodenal mucosa. The procedure aims to reset metabolic pathways, including insulin resistance, to prevent and potentially reverse metabolic disease progression. Fractyl Laboratories is recruiting patients with Type 2 diabetes for a U.S. clinical trial across five sites for the Revita DRM therapy.
“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,” Fractyl CEO Dr. Harith Rajagopalan said in the release. “This exceptional data will inform our U.S. 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.”
“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,” added Fractyl chief medical officer Dr. Juan Carlos Lopez-Talavera. “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 (nonalcoholic steatohepatitis) 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.”