Duodenal Mucosal Resurfacing Improves Broad Metabolic Measures in Type 2 Diabetes

WALTHAM, MA AND NEW ORLEANS, LA – June 10, 2016 – Fractyl Laboratories, Inc. (Fractyl) announced today that new data on the Company’s Revita DMRTM System, used to perform minimally invasive duodenal mucosal resurfacing for the treatment of metabolic diseases (Revita DMR procedure), was disclosed as part of an oral presentation at the 2016 Scientific Sessions of the American Diabetes Association. The presentation, Endoscopic Duodenal Mucosal Resurfacing (DMR) Improves Metabolic Measures in Type 2 Diabetes: First-in-Human Study 6-Month Data, was made by Alan Cherrington, PhD.  In the study, DMR not only improved glycemic control in patients with type 2 diabetes, but also improved broader metabolic indices that are indicative of an insulin sensitizing mechanism with reduced systemic inflammation. Fractyl also announced that safety and efficacy data with a minimum follow up of 12 weeks has been collected on 28 patients in the international, multi-center trial that is currently enrolling.

“This presentation of first-in-human data is the most comprehensive look we have thus far at the potential impact that duodenal resurfacing can have on insulin resistance and metabolic diseases, including type 2 diabetes,” said Alan Cherrington, PhD, Professor of Molecular Physiology and Biophysics, Professor of Medicine & Jacquelyn A. Turner and Dr. Dorothy J. Turner Chair in Diabetes Research, Vanderbilt University, Nashville, Tennessee. “This is a very interesting time to be working in the field of metabolic diseases. The new guidelines published last month recommending that bariatric surgery be considered as a treatment for type 2 diabetes patients with inadequate blood glucose control are an historic change. Given the scale of the diabetes and liver epidemics, however, we need to explore less invasive approaches.”

In the first-in-human study, the safety and efficacy of Revita DMR was studied in 39 patients with suboptimally controlled type 2 diabetes (defined as HbA1c > 7.5% and on at least one 1 anti-diabetic agent) who were less than 10 years from their initial diagnosis. At six months, patients receiving DMR had improvements in fasting glucose and HbA1c, lowering of hepatic transaminase levels, and lowering of HOMA-IR (an index of insulin resistance). Additional metabolomic assessments showed improvements in systemic insulin sensitivity, and lowered inflammatory markers. A 50 patient multicenter, international clinical trial is currently underway. Currently, 28 patients have enrolled, been treated and been followed for at least 12 weeks across sites in the United Kingdom, Chile, Italy, Netherlands and Brussels.

“Over the last two months, we have had the opportunity to present to and learn from different specialties across the disciplines that treat and study the major metabolic diseases. We believe we are developing an intervention that can reverse a critical pathological defect that is a driver of multiple metabolic conditions,” said Harith Rajagopalan, MD, PhD, Co-Founder and CEO of Fractyl.

Presentations of Revita DMR data in the second quarter of 2016 included:

  • International Liver Conference of the European Association for the Study of Liver (EASL), Barcelona, Spain, April 13-17
  • Digestive Disease Week, San Diego, CA, May 22-24
  • American Association of Clinical Endocrinologists, Orlando, FL, May 25-29
  • American Diabetes Association, New Orleans, June 10-14

About Insulin Resistance and Metabolic Diseases

Nonalcoholic fatty liver disease (NAFLD) and type 2 diabetes are two of the most prevalent metabolic diseases. NAFLD is a condition in which fat accumulates in the liver in association with common manifestations of metabolic disease, such an altered lipid profile and insulin resistance. NAFLD can progress to nonalcoholic steatohepatitis (NASH) and lead to liver inflammation and fibrosis, which can place NASH patients at higher risk of developing cirrhosis, liver failure and liver cancer. Type 2 diabetes is characterized by hyperglycemia resulting from the resistance of the body to insulin action. In both NAFLD and type 2 diabetes, insulin resistance is a key driver of both disease processes. Approximately 50 percent of patients with NASH also have type 2 diabetes. There are currently no available pharmaceutical or procedural therapies specifically approved for NAFLD or NASH.

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About Fractyl and the Revita™ Duodenal Mucosal Resurfacing (DMR) System

Fractyl Laboratories, Inc. is a private, clinical-stage medical technology company based in Waltham, MA. Fractyl is developing Revita DMR, a same-day, minimally invasive, device-based procedure to treat insulin resistance, the underlying metabolic cause of type 2 diabetes and NASH (nonalcoholic steatohepatitis). Fractyl aims to alleviate the daily burdens of disease management for patients and physicians with a safe and reliable therapeutic treatment for insulin resistance and lower the tremendous health and financial burden of metabolic disease. The Revita DMR procedure and device are currently being evaluated in clinical trials. For more information, visit www.fractyl.com or www.twitter.com/FractylLabs, or www.RevitaTrial.com. The Revita DMR System received European CE Mark approval in April 2016.

Media Contact
Russell LaMontagne
russell@corinthgroup.com
Tel: 917-744-7957

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