LEXINGTON, Mass.--(BUSINESS WIRE)--Fractyl Laboratories Inc. (Fractyl) today announced positive results from the Revita-2 trial evaluating Revita DMR (duodenal mucosal resurfacing) for the treatment of type 2 diabetes patients with and without nonalcoholic fatty liver disease (NAFLD), of which the more serious condition is nonalcoholic steatohepatitis (NASH). The results from Revita-2, Fractyl’s first sham-controlled, multicenter clinical trial of Revita DMR, will be presented in a late-breaker oral presentation (#L02) on Monday, November 11 at 2:45 pm at The Liver Meeting® 2019, the annual meeting of the American Association for the Study of Liver Disease (AASLD) in Boston. This presentation has been recognized as ‘Best of the Liver 2019,’ a recognition that highlights the most noteworthy contributions to the scientific program at The Liver Meeting.
The Revita-2 study was a double-blinded study of the Revita DMR procedural therapy, in which patients enrolled in the study and the physicians caring for the patient after the procedure, were blinded to the treatment arm for 24 weeks through the primary endpoint. The trial tested a 10 cm circumferential ablation length (“10 cm dose”) versus a sham procedure (in which the Revita catheter was inserted into the duodenum for a similar duration, but not activated). In both treatment arms, all patients received a two-week post-procedure graduating diet from liquids to semi-solids and solids.
For the twin primary endpoints of reduction in HbA1c and liver MRI-PDFF, Revita DMR demonstrated a statistically significant improvement over sham, with a 0.8% reduction in HbA1c at 24 weeks and a 32% relative reduction in MRI-PDFF at 12 weeks (per protocol study results; p < 0.05 for each endpoint). Reductions in HbA1c were caused by improvements in fasting glucose, and patients with higher fasting plasma glucose at baseline had a 1.2% reduction in HbA1c at 24 weeks (p < 0.01). Sustained improvements in both liver insulin sensitivity and pancreatic beta-cell function were seen after the procedure. The data also showed that Revita DMR, a minimally invasive, outpatient procedural therapy that resurfaces the duodenal mucosa, is safe relative to a sham upper endoscopy procedure.
“This data shows that duodenal mucosal resurfacing (DMR) can improve liver metabolic health, leading to improvements in both blood sugar and liver disease simultaneously,” said Dr. Arun Sanyal, Professor of Medicine, Physiology and Molecular Pathology at Virginia Commonwealth University. “This data supports Revita DMR as a non-pharmacological intervention for patients who are managing type 2 diabetes and NAFLD/NASH and shows that Revita DMR can provide significant improvements in blood glucose levels and liver insulin resistance, even for those patients with NAFLD.”
“Revita DMR is a fundamentally different approach to treating type 2 diabetes and NAFLD/NASH that we believe targets the root cause of the disease to provide significant and sustained metabolic benefits, from a single outpatient therapy,” said Harith Rajagopalan, M.D., Ph.D., co-founder and CEO of Fractyl. “These Revita-2 results help to establish the safety and effectiveness of Revita in improving glucose control, reducing liver fat content, enhancing insulin sensitivity, and reducing weight in patients with type 2 diabetes. These data will be critical to helping us continue development of Revita in type 2 diabetes with NAFLD.”
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, which can lead to significant improvements in metabolic disease parameters, reduced need for medication usage, and greater patient satisfaction with their therapy.
About Type 2 Diabetes and NAFLD/NASH
Type 2 diabetes and NAFLD/NASH are two of the most prevalent metabolic diseases and have reached epidemic levels in the United States and around the world, affecting nearly a billion people. An estimated 18 million people in the United States have both conditions, which greatly increases their risk of negative health outcomes. While there is 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 level.1 There are currently no FDA-approved treatments for NAFLD/NASH.
About Fractyl and RevitaⓇ DMR
Fractyl Laboratories is a private biotechnology company based in Lexington, Mass. Fractyl is developing Revita DMR, a same-day, minimally invasive procedural therapy to treat highly prevalent metabolic diseases. The Revita DMR procedure harnesses breakthrough insights in intestinal biology and leverages the body’s inherent regenerative capacity to reverse insulin resistance and metabolic diseases. Fractyl’s approach aims to improve the health of patients with metabolic diseases with device-based interventions for patients and healthcare systems. The Revita DMR System received a CE mark in the European Union in April 2016. It is approved for investigational use by the Food and Drug Administration in the United States. The Revita DMR System may be available for investigational use in other regions. For more information, visit www.fractyl.com or www.twitter.com/FractylLabs.
1. JAMA Internal Medicine, August 2019, doi:10.1001/jamainternmed.2019.2396