Fractyl Announces Positive Topline Results in the Revita-2 Clinical Trial in Patients with Type 2 Diabetes and Nonalcoholic Fatty Liver Disease

-Successful completion of Fractyl’s first sham-controlled, multicenter clinical trial of Revita DMR to support EU commercial launch and inform U.S. pivotal clinical trial. -Revita-2 data support Revita DMR as a non-pharmacological intervention that can halt and even reverse progression of metabolic diseases, including type 2 diabetes and NAFLD, of which the more serious condition is nonalcoholic steatohepatitis (NASH)

LEXINGTON, Mass., September 9, 2019 — Fractyl Laboratories Inc. (Fractyl), the leader in translating new insights in gut biology into transformative therapies for patients with metabolic diseases, today announced positive topline results from Revita-2, the first randomized, double-blind, sham-controlled, multicenter clinical trial of Fractyl’s Revita™DMR. Data from patients with type 2 diabetes (T2D) with and without nonalcoholic fatty liver disease (NAFLD) show that Revita DMR, a minimally invasive, outpatient procedural therapy that resurfaces the duodenal mucosa, is safe and effective relative to a sham procedure. Full results from the Revita-2 trial are expected to be presented at an upcoming scientific meeting.

“With a 45-minute outpatient Revita DMR procedure, we saw remarkable and sustained improvements in lowering blood sugar, reducing liver fat, reducing weight, and improving insulin sensitivity markers for type 2 diabetes patients with and without NAFLD,” said Harith Rajagopalan, M.D., Ph.D., co-founder and CEO of Fractyl. “This exceptional data will inform our U.S. pivotal clinical trial and support our commercial launch in the European Union, and we look forward to presenting the data from the Revita-2 clinical trial later this year.”

T2D 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 are 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.

Professor David Hopkins, Director of the Institute of Diabetes Endocrinology and Obesity, Kings Health Partners, London, added, “Patients with type 2 diabetes suffer from many severe co-morbidities and are often struggling to manage their disease with multiple daily medications. By targeting insulin resistance in the duodenum — the root cause of metabolic disease — a single Revita DMR procedure has considerable benefits and will become an important alternative to escalating drug treatment.”

Building on years of research about the gut’s critical role as a root cause of metabolic disease, the Revita duodenal mucosal resurfacing (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, leading to significant improvements in metabolic disease parameters, reduced need for medication usage, and greater patient satisfaction with their therapy.

“Fractyl has developed an extraordinary endoscopy device and procedure that is the first to show disease modification for type 2 diabetes and NAFLD/NASH,” stated Jacques Bergman, M.D., Ph.D., professor of Gastrointestinal Endoscopy at Amsterdam UMC and principal investigator of the Revita-2 study. “The procedure is straightforward to learn and perform and has now been shown to be safe and effective in hundreds of patients.”

“Nonalcoholic fatty liver disease has become a major concern for healthcare providers, especially for those caring for patients who also have type 2 diabetes, which exacerbates the course of liver disease and makes managing diabetes more difficult,” explained Juan Carlos Lopez-Talavera, M.D., Ph.D., chief medical officer of Fractyl. “The significant improvement in markers of insulin resistance along with glycemic and hepatic indices indicates that Revita DMR is positioned to be an important nonpharmacological treatment option to correct the course of these metabolic diseases.”

Dr. Lopez-Talavera, concluded, “We want to thank our study investigators and especially the patients for completing this important clinical trial. Revita DMR is a breakthrough approach to type 2 diabetes, NAFLD/NASH, and other insulin-resistant metabolic diseases and can not only provide significant and sustained disease modification but also reduce the disease management burden and costs for patients and payers.”

A U.S. clinical trial for Revita DMR is currently recruiting patients with T2D at five sites.  For a full list of inclusion and exclusion criteria, visit ClinicalTrials.gov.

1. JAMA Internal Medicine, August 2019, doi:10.1001/jamainternmed.2019.2396

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 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.

Corporate Contact:

Lisa Davidson, Chief Financial Officer,
17 Hartwell Avenue, Lexington, MA 02421,
lisa@fractyl.com, +1.781.902.8800

Media Contact:

Jessica Yingling, Ph.D.,
Little Dog Communications Inc.,
jessica@litldog.com, +1.858.344.8091