LEXINGTON, Mass., October 20, 2017 – Fractyl Laboratories Inc. (Fractyl) today announced that clinical investigators for the Revita-1 clinical trial today will present 12-month data from the study showing sustained improvement in hepatic and glycemic parameters following a single treatment with Revita™ DMR in patients with type 2 diabetes (T2D) and presumed fatty liver disease. The data will be presented at AASLD’s The Liver Meeting® 2017 taking place October 20-24 in Washington, DC.
“Non-alcoholic fatty liver disease is highly prevalent in type 2 diabetes and represents an important unmet need in our clinical care,” said Harith Rajagopalan, M.D., Ph.D., cofounder and CEO of Fractyl. “With a one-time treatment with Revita DMR and without intensive lifestyle changes by the patient, we see an insulin-sensitizing effect and durable improvements in hepatic and glycemic indices over a year. The simultaneous improvement in both conditions demonstrates the potential for Revita DMR to impact the underlying pathology of insulin resistance that is driving type 2 diabetes and fatty liver disease.”
The data from Revita-1, a single arm, open label, multicenter study, reports that a single DMR procedure produced sustained reductions in hepatic and glycemic indices, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), HbA1c, and markers of insulin resistance (HOMA-IR) out to at least 12 months. Data showing sustained improvement in glycemic parameters was presented at EASD 2017.
Data to be presented at AASLD 2017 describes significant reductions in ALT levels seen in the highest baseline ALT subgroup (59+/-23 U/L). ALT was significantly lower at three months (-22+/-15 U/L) and remained lower than baseline at 12 months (-16+/-20 U/L) with concomitant lowering of glycemia and without significant weight loss or further lifestyle interventions. Further studies are necessary to quantify the hepatic and glycemic effects associated with Revita DMR. A larger, randomized, multicenter, sham-controlled, blinded study, called Revita-2, is currently enrolling patients in Europe and Brazil to further evaluate the safety and efficacy of the Revita DMR System in orally-treated T2D patients with poorly controlled disease.
“These data are very exciting because they represent an innovation where a single minimally invasive endoscopic intervention has a profound and lasting effect on the metabolic status of patients with the metabolic syndrome who are at risk of nonalcoholic fatty liver disease,” said Professor Arun Sanyal, M.D., Chair of the Division of Gastroenterology, Hepatology and Nutrition at the Virginia Commonwealth University (VCU) School of Medicine.
Revita DMR is a minimally invasive, therapeutic procedure designed to rejuvenate the duodenum. It is intended as an outpatient therapy to be performed in less than one hour and allow patients to resume normal activities the following day. By rejuvenating the surface of the duodenum, Revita DMR is designed to address insulin resistance directly and improve the management of T2D and metabolic disease.
The poster (2138) entitled, “Improvement in Hepatic Transaminases Over 12 Months After Single Procedure Duodenal Mucosal Resurfacing in Type 2 Diabetes Patients,” will be presented on Monday, October 23rd between 12:30 pm and 2:00 pm EDT during the Poster Session IV: Steatosis and Steatohepatitis.
In addition, a poster will be presented at the 25th UEG Week in Barcelona on Tuesday, October 31, from 12:30 pm to 1:30 pm CET, The poster (P0796) has the same title as above and will be located in Scientific Centre Terminal 4, during the poster champ session: surgery, endoscopy, and imaging.
About Insulin Resistance and Metabolic Diseases
The term “metabolic disease” refers to a broad group of conditions in which the body’s normal metabolic processes become disordered. The most common metabolic diseases—T2D and nonalcoholic fatty liver disease / nonalcoholic steatohepatitis (NAFLD/NASH)—occur as a result of insulin resistance. T2D is characterized by hyperglycemia resulting from insulin resistance and the resulting failure of the pancreas to produce sufficient insulin to meet the body’s needs. NAFLD is a condition in which fat accumulates in the liver, also caused by insulin resistance, and represents an important manifestation of metabolic disease in the liver. NAFLD can progress to NASH and lead to liver inflammation and fibrosis, which can place NASH patients at higher risk of developing cirrhosis, liver failure and liver cancer.
About Fractyl and Revita™ DMR
Fractyl Laboratories is a private medical technology company based in Lexington, Mass. Fractyl is developing Revita DMR, a same-day, minimally-invasive procedure to treat two highly prevalent metabolic diseases: type 2 diabetes and NAFLD/NASH. The Revita DMR procedure harnesses current insights from bariatric science to address a root cause of insulin resistance in the duodenum. 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 has not been 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.
Corporate Contact: Lisa Davidson, Chief Financial Officer, Fractyl Laboratories Inc., firstname.lastname@example.org, +1.781.902.8804