Fractyl Health presents new mechanistic data on Revita DMR

Fractyl Health, an organ-editing metabolic therapeutics company focused on pioneering a new approach to the treatment of type 2 diabetes (T2D), announced today new data from its Revita-1 and Revita-2 studies. Prior publications from these open-label and sham-controlled studies have shown improvements in glycemic control and weight in subjects with inadequately controlled type 2 diabetes. New data presented at this week’s Digestive Disease Week® (DDW) 2022 build on this earlier evidence to assess the effect of Revita on insulin resistance, insulin production capacity, and key metabolic hormones via a mixed meal tolerance test.

In the current investigation 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 in the Revita-1 and Revita-2 open-label training phase studies in whom mixed meal tolerance tests were performed at baseline and three months post-intervention. Results in these subjects (n=28) exhibited the following findings at three months after a single outpatient procedure:

• Glycemic control: 0.8%-point reduction in HbA1c (from baseline of 8.2%; p=0.002) and 36 mg/dL reduction in fasting plasma glucose (from baseline 198 mg/dL; p<0.001)
• Weight loss:4.3 kg reduction in weight (4.7% total body weight loss; p<0.001)
• Insulin resistance: 33% improvement in HOMA-IR and 32% improvement in the Matsuda Index, two measures of insulin resistance that have been associated with a heightened risk of T2D progression (p=0.005 for each)
• Beta cell function: 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 in response to a meal (p=0.002 and p=0.001, respectively)
• Gut hormones: The response of two key gut hormones known to regulate blood sugar (GIP and GLP-1) in response to a meal was unchanged after treatment with Revita

The 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 intervention,” said Juan Carlos Lopez-Talavera, M.D. Ph.D., Chief Medical Officer, Fractyl Health. “These results raise intriguing questions about the potential for therapeutic interventions targeting the duodenum to help address underlying root causes of metabolic dysfunction in people with T2D.” Business Wire