Fractyl Laboratories announced positive topline results from the phase 2 trial of Revita duodenal mucosal resurfacing, or DMR, a minimally invasive outpatient procedural therapy for patients with nonalcoholic fatty liver disease and type 2 diabetes, according to a press release.
“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,” Harith Rajagopalan, MD, PhD, cofounder and CEO of Fractyl, 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.”
The Revita DMR procedure was designed to reset key metabolic pathways, including insulin resistance, to prevent and potentially reverse metabolic disease progression. The endoscopic procedure is performed the same day and uses heat to resurface the lining of the upper intestine.
Patients in the randomized control trial achieved improvements in metabolic disease parameters, reduced need for medication use and had positive patient-reported outcomes.
“Fractyl has developed an extraordinary endoscopy device and procedure that is the first to show disease modification for type 2 diabetes and NAFLD/NASH,” Jacques Bergman, MD, PhD, professor of gastrointestinal endoscopy at Amsterdam UMC in the Netherlands and principal investigator of the Revita-2 study, said. “The procedure is straightforward to learn and perform and has now been shown to be safe and effective in hundreds of patients.”