Fractyl Announces New Data from Revita-1 Clinical Study Showing Durable Benefits after a Single Treatment Through Two Years of Follow Up

Fractyl Laboratories Inc. (Fractyl) today announced that the company will present positive results from the long-term follow-up from the Revita-1 study² at the Diabetes Technology Meeting taking place in Bethesda, Md. The data shows that patients experienced a 1% reduction in HbA1c (from a baseline HbA1c of 8.5% to 7.5%; n=34; p < 0.01) through 24 months of follow-up from a single outpatient Revita DMR procedure. Durable improvements in liver biomarkers were also observed over the same length of time, indicating the potential for Fractyl's Revita^? DMR (duodenal mucosal resurfacing) to offer durable improvements in both type 2 diabetes and NAFLD/NASH for a full two years. In addition, the data shows an 80% response rate with a large magnitude reduction in responders. Patient satisfaction scores were significantly improved at 12 months and no late adverse events attributable to Revita were observed.

"Diabetes is a chronic progressive disease characterized by ongoing deterioration of glycemic control, even in the presence of an increasing number of anti-diabetic medications. What is sorely needed is an effective means of changing the trajectory of disease for patients," said Alan Cherrington, Ph.D., Professor of Molecular Physiology and Biophysics, Professor of Medicine & Jacquelyn A. Turner and Dr. Dorothy J. Turner Chair in Diabetes Research, Vanderbilt University. "This work shows that ablation of the duodenal mucosa via Revita may provide a safe and effective means of achieving that reversal, targeting the gut to address a core pathophysiological mechanism of disease."

"Revita is a fundamentally different approach to treating type 2 diabetes and NAFLD/NASH that we believe provides significant and sustained metabolic benefits from a single, outpatient therapy," said Harith Rajagopalan, M.D., Ph.D., co-founder and CEO of Fractyl. "Revita's effects appear to be durable through at least 24 months in a majority of patients, demonstrating its potential to ameliorate these two major pandemics with a straightforward, outpatient procedural therapy performed under an hour in a manner that is complementary to existing therapies."

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, which can lead to significant improvements in metabolic disease parameters, reduced need for medication usage, and greater patient satisfaction with their therapy.

The Revita-1 two-year data will be presented on November 15 from 4:30 pm to 6:30 pm ET (VAN 19122D) at the Diabetes Technology Meeting taking place in Bethesda, Md. In addition, on November 16 at 4:40 pm ET, Juan Carlos Lopez-Talavera, M.D., Ph.D., chief medical officer of Fractyl will give a demonstration of Revita DMR. See the full agenda here.

About Type 2 Diabetes and NAFLD/NASH

Type 2 diabetes 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 is 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.

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 is 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.

1. JAMA Internal Medicine, August 2019, doi:10.1001/jamainternmed.2019.2396
2. Gut, July 2019, doi:10.1136/gutjnl-2019-318349