Fractyl Presents New Revita DMR Liver Data in Type 2 Diabetes at AASLD 2016

BOSTON, MA – November 11, 2016 – Fractyl Laboratories Inc. (Fractyl) presented two late breaking abstracts today at the 2016 annual meeting of the American Association for the Study of Liver Diseases:

• Rajagopalan et al. “Endoscopic duodenal mucosal resurfacing (DMR) improves insulin sensitivity, hepatic transaminase levels and anti-inflammatory markers in type 2 diabetes subjects” (LB-34)
• van Baar et al. “A single endoscopic duodenal mucosal resurfacing procedure exerts a sustained improvement in hepatic transaminase levels in a cohort of type 2 diabetes patients.” (LB-35)

The company also announced the publication of a Revita DMR case study in the inaugural issue of Video GIE.

“Understanding the relationship between insulin resistance and disease progression in patients with type 2 diabetes and liver disease is a primary goal for our team. Our findings presented at The Liver Meeting today contribute to a growing body of evidence suggesting that Revita DMR may address the underlying metabolic complications of insulin resistance and could represent a new treatment option in patients with type 2 diabetes and fatty liver disease,” said Harith Rajagopalan, MD, PhD, Co-Founder and CEO of Fractyl.

Revita DMR is a trans-oral procedure targeting the duodenum, a portion of the intestine that plays an important role in regulating insulin sensitivity and metabolic homeostasis. Using proprietary balloon catheters, Revita DMR uses a combination of circumferential mucosal lift and hydrothermal ablation to rejuvenate the surface of the duodenum and potentially alter gut signaling in patients with metabolic diseases driven by insulin resistance. It is designed to be a short (< 60 min), minimally invasive procedure with the potential to restore metabolic health while avoiding many of the challenges patients and physicians face managing complicated medical regimens. A 50-patient, multicenter, international clinical trial is currently underway in patients with type 2 diabetes, in which 45 patients have already been treated across sites in the United Kingdom, Chile, Italy, Netherlands and Belgium.

“Insulin resistance is a common metabolic driver of type 2 diabetes, fatty liver disease and NASH,” said Arun J. Sanyal, MD, Professor of Medicine, Physiology and Molecular Pathology Virginia Commonwealth University School of Medicine.  “The ability of Revita DMR to significantly improve markers of insulin resistance along with glycemic and hepatic indices suggests an interesting method for changing the course of these metabolic diseases.”

In abstract LB-34, Rajagopalan et al. reported data on a subcohort of patients with type 2 diabetes in the first-in-human study of Revita DMR, showing improvements in markers of insulin resistance, systemic inflammation and oxidative stress post-procedure, suggesting that Revita DMR may be a method for correction of hyperglycemia and key pathophysiological drivers of fatty liver disease.

In abstract LB-35, van Baar et al. reported on hepatic transaminase levels after Revita DMR in subjects with type 2 diabetes from a composite of two clinical studies and a minimum follow-up of 6 months. In both studies, a single DMR procedure (median length of ablation: ~9 cm) improved both glycemic markers and markers of fatty liver disease, also leading to a decrease in liver transaminase levels that was sustained for 12 months.

About Insulin Resistance and Metabolic Diseases

Type 2 diabetes and nonalcoholic fatty liver disease (NAFLD) are two of the most prevalent metabolic diseases around the world. In both type 2 diabetes and NAFLD, insulin resistance is a key driver of the disease process. Type 2 diabetes is characterized by hyperglycemia resulting from the resistance of the body to insulin and 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, and represents an important manifestation of metabolic disease in the liver. 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. Approximately 50 percent of patients with NASH also have type 2 diabetes, and there are currently no available pharmaceutical or procedural therapies specifically approved for NAFLD or NASH.

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

Fractyl Laboratories is a private medical technology company based in Lexington, MA. 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 insulin resistance at its source. Fractyl’s approach aims to improve the health of patients with metabolic diseases with device-based interventions that relieve the burden these diseases cause for patients and healthcare systems. 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.