LEXINGTON, Mass.–(BUSINESS WIRE)–Fractyl Health, an organ-editing metabolic therapy company focused on an innovative new approach to treating type 2 diabetes (T2D), today announced new data from its Revita studies -1 and Revita-2. Previous publications of these sham-controlled, open-label studies have shown improvements in glycemic control and weight in subjects with poorly controlled type 2 diabetes. New data presented this week at Digestive Disease Week® (DDW) 2022 builds on this earlier evidence to assess the effect of Revita on insulin resistance, insulin-producing capacity and metabolic hormones keys via a mixed meal tolerance test.

In the current survey presented at DDW 2022, a pooled post-hoc mechanistic analysis of insulin sensitivity, beta cell function, and metabolic hormone assessment was performed in all patients who were treated as part of the Revita-1 and Revita-2 open training. phase studies in which mixed meal tolerance tests were carried out at baseline and three months after the intervention. Results in these subjects (n=28) showed the following results at three months after a single outpatient procedure:

• Glycemic control: 0.8% reduction in HbA1c (from baseline 8.2%; p=0.002) and 36 mg/dL reduction in fasting blood glucose (from baseline 198 mg/dL; p
• Weightloss: Weight reduction of 4.3 kg (total weight loss of 4.7%; p
• Insulin resistance: 33% improvement in HOMA-IR and 32% in Matsuda Index, two measures of insulin resistance that have been associated with an increased risk of T2D progression (p=0.005 for each)
• Function of beta cells: 25% improvement in insulin secretion rate and 37% improvement in disposition index, two measures of pancreatic beta cell function that reflect an improvement in the pancreas’ ability to produce and secrete insulin insulin in response to a meal (p=0.002 and p=0.001, respectively)
• Intestinal hormones: The response of two key gut hormones known to regulate blood sugar (GIP and GLP-1) in response to a meal remained unchanged after treatment with Revita

“Current data suggest that Revita may be the first investigational therapy to offer the potential for improvements in insulin sensitivity and pancreatic beta cell function months after a single, minimally invasive outpatient procedure,” said Juan Carlos. Lopez-Talavera, MD Ph.D., Chief Medical Officer, Fractyl Health. “These results raise intriguing questions about the potential of therapeutic interventions targeting the duodenum to help address the underlying root causes of metabolic dysfunction in people with T2DM.”

About Revita®

Fractyl Health’s lead product candidate, Revita, is based on the company’s knowledge of the gut’s potential role in metabolic disease. Revita is designed to reshape the duodenal mucosa through hydrothermal ablation (i.e. resurfacing of the duodenal mucosa) to alter abnormal gut nutrient sensing and signaling mechanisms that are a potential cause of metabolic disease. In April 2016, Revita received CE marking from the European Union. In the United States, Revita is intended for investigational use only and has received FDA Breakthrough Device designation for improving glycemic control and eliminating insulin requirements in patients with T2DM who are not adequately controlled by long-acting insulin.

About the Revitalize T2D Clinical Development Program

The Revitalize T2D program is a series of ongoing and planned clinical studies sponsored by Fractyl Health to investigate the potential usefulness of Revita in patients with T2D or at high risk. The Company’s ongoing pivotal clinical study, Revitalize-1, is designed as a randomized, double-blind, sham-controlled, multicenter crossover study in patients with inadequately controlled T2D despite being on metformin, up to two additional ADAs and one long-acting insulin. The Revitalize-2 study is an ongoing pivotal study in patients with T2D who are not adequately controlled on two or three ADAs for whom insulin would be the next therapeutic step. The Revitalize-3 proof-of-concept pilot study is a planned study in patients with high-risk prediabetes to evaluate the effects of hydrothermal ablation of the duodenal mucosa using Revita to reduce the risk of developing a T2D.

About Fractyl Health

Fractyl Health is focused on developing a new approach to the treatment of T2DM. Despite advances in treatment over the past 50 years, metabolic diseases in general, and T2D in particular, continue to be a major and rapidly growing factor in morbidity and mortality in the 21st century. Fractyl Health’s goal is to transform the treatment of T2DM from chronic glucose management into disease-modifying therapies that target the root causes of the disease at the organ level. Fractyl Health’s lead product candidate, Revita, is designed to reshape the duodenal mucosa through hydrothermal ablation (i.e. resurfacing of the duodenal mucosa) to alter the abnormal gut nutrient sensing and signaling mechanisms that are a potential cause of metabolic diseases. Fractyl Health is a private metabolic therapy company based in Lexington, MA. For more information, visit www.fractyl.com or www.twitter.com/FractylHealth

About Digestive Diseases Week®

Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and scholars in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT), DDW is an in-person and virtual meeting May 21-24, 2022. The meeting features over 3,100 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org.