AP NEWS
Press release content from Business Wire. The AP news staff was not involved in its creation.
PRESS RELEASE: Paid content from Business Wire
Press release content from Business Wire. The AP news staff was not involved in its creation.

Fractyl Announces New Clinical Data Showing Same-Day Procedure Can Benefit Both NAFLD/NASH and Type 2 Diabetes

April 4, 2019

LEXINGTON, Mass.--(BUSINESS WIRE)--Apr 4, 2019--Fractyl Laboratories Inc. ( Fractyl ) today announced the presentation of new clinical data showing its same-day therapeutic procedure can generate significant improvements in both non-alcoholic fatty liver disease (NAFLD/NASH) and type 2 diabetes (T2D) in people with both conditions. This first-of-its-kind data will be presented at The International Liver Congress™ (ILC 2019), the EASL annual meeting, in Vienna, Austria, in a plenary session (PS-112) entitled, “Endoscopic duodenal mucosal resurfacing (DMR) improves hepatic fat fraction, glycemic and lipid profiles in type 2 diabetes,” on Friday, April 12, from 5:45 pm to 6 pm (GMT+1). This presentation has been recognized as ‘Best of ILC,’ a recognition that highlights the most noteworthy contributions to the scientific program at ILC 2019.

NAFLD/NASH and T2D have both reached epidemic levels in the United States and around the world. Of particular concern are the estimated 18 million Americans who have both conditions, which greatly increases their risk of negative outcomes. 1 There are currently no FDA-approved treatments for NAFLD/NASH and no same-day procedure that strikes at the intersection of the two diseases.

“There are no FDA-approved treatments for NAFLD/NASH, and type 2 diabetes can be difficult to treat effectively, due to issues with compliance and drug side effects,” said Dr. Arun Sanyal, Professor of Medicine, Physiology and Molecular Pathology at Virginia Commonwealth University and past president of the American Association for Study of Liver Diseases. “We have long surmised a key role of the duodenum in contributing to metabolic diseases. A potent therapy targeting the duodenum that can strike at both NAFLD/NASH and type 2 diabetes would be potentially transformative for millions of patients.”

The Revita™ duodenal mucosal resurfacing (DMR) procedure is a novel endoscopic therapy that uses heat to ablate the lining of the duodenum. The approach aims to reset key metabolic pathways arising from the duodenum. Earlier studies have demonstrated sustained improvements in blood glucose levels and insulin resistance measures through one year of follow-up in patients with T2D. The latest data, to be presented at ILC 2019, show the metabolic benefits extend to NAFLD/NASH, lowering liver fat by 36%. Nearly 95% of treated patients showed improvement in either glucose or liver fat, with 88% of patients showing improvement in both within three months of treatment. Additional benefits from the therapy were improvement in cardiovascular risk (lowering triglyceride/HDL ratio by 28%), and in weight, with 3.1 kg weight loss unaided by any lifestyle intervention. As with earlier clinical studies, Revita DMR was well-tolerated and proved to be safe in this study of patients with NAFLD/NASH and T2D.

“Data from our clinical studies thus far demonstrate that our minimally invasive, same-day procedure can be an efficient therapeutic approach with significant clinical benefit for patients at high risk of complications from their metabolic diseases,” said Harith Rajagopalan, M.D., Ph.D., co-founder and CEO of Fractyl. “We are heartened by these results and look forward to data from the randomized studies to be reported later this year that will form the basis for commercialization and upcoming U.S. pivotal studies.”

1. Bazick et al. Diabetes Care, 2015.

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 highly prevalent metabolic diseases. The Revita DMR procedure harnesses breakthrough insights in the role of the duodenum in causing 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 has 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.

View source version on businesswire.com:https://www.businesswire.com/news/home/20190404005009/en/

Corporate Contact: Lisa Davidson, Chief Financial Officer, Fractyl Laboratories Inc.,lisa@fractyl.com, +1.781.902.8800Media Contact: Jessica Yingling, Ph.D.,Little Dog Communications Inc.,jessica@litldog.com, +1.858.344.8091

KEYWORD: AUSTRIA UNITED STATES EUROPE NORTH AMERICA MASSACHUSETTS

INDUSTRY KEYWORD: SURGERY HEALTH BIOTECHNOLOGY MEDICAL DEVICES RESEARCH DIABETES SCIENCE

SOURCE: Fractyl Laboratories Inc.

Copyright Business Wire 2019.

PUB: 04/04/2019 09:00 AM/DISC: 04/04/2019 09:01 AM

http://www.businesswire.com/news/home/20190404005009/en