Fractyl Health Publishes Two-Year Durability Data After a Single Revita DMR® Therapeutic Procedure in Patients with Type 2 Diabetes

LEXINGTON, MA., February 1, 2022 - Fractyl Health, an organ-editing metabolic therapeutics company focused on pioneering a new approach to the treatment of type 2 diabetes (T2D), announced today the publication of two-year durability data from its REVITA-1 clinical study conducted at centers in Europe and South America. The publication, “Durable Metabolic Improvements 2 Years After Duodenal Mucosal Resurfacing (DMR) in Patients with Type 2 Diabetes (REVITA-1 Study),” appeared in the January 12, 2022, online issue of Diabetes Research and Clinical Practice. With two-year follow-up from 34 patients in the per-protocol (PP) population, the study observed no long-term adverse events from Revita in patients with poorly controlled diabetes on oral glucose-lowering medications. In the cohort followed through two years, HbA1c was observed to be statistically significantly reduced at all time points, as were broader measures of metabolic control, including reductions in weight and improvements in patient self-reported diabetes treatment satisfaction questionnaires (DTSQc).

"In this publication, we are beginning to get a picture of the long-term safety, tolerability, and metabolic benefits from the Revita procedure in patients who are poorly controlled on oral antidiabetic agents,” said David Hopkins, FRCP, Director of the Diabetes Endocrinology and Obesity Institute and Network, King’s Health Partners, London. “We are encouraged by the long-term follow-up of these patients and look forward to longer term outcomes from the ongoing Revitalize T2D clinical development program in patients across the spectrum of T2D.” 

About REVITA-1
REVITA-1 was an open-label feasibility study of Revita in subjects with poorly controlled T2D despite being on at least one oral antidiabetic agent which enrolled 34 subjects in the PP population. The baseline characteristics of these patients are as follows:
 
Baseline Characteristics Revita DMR n=9 mean (SD)
Age – years  56.2 (7.6)
Male sex – no. (%) 22 (64.7%)
BMI – kg/m2 30.4 (3.7)
Weight – kg 88.9 (11.8)
Diabetes duration – years  6.5 (2.4)
Glycated hemoglobin – %  8.5% (0.7)
C-peptide – ng/mL 3.1 (1.3)
HDL – mg/dL 42.4 (9.2)
TG – mg/dL 193.9 (122.1)
LDL – mg/dL 95.8 (28.9)
Diabetes treatment survey questionnaire – static (DTSQs) 27.5 (6.6)

In long-term safety follow-up, there were no treatment-related adverse event related to the device or procedure. One patient had mild constipation and another patient had mild vitamin B12 deficiency. No device- or procedure-related serious adverse events, unanticipated device effects, or hypoglycemic events were observed between month six and month 24. 

At 24 months following a single Revita procedure, we observed a statistically significant mean HbA1c reduction of 1.0% (n=28; p=0.034) from baseline, with most of the patients reducing or remaining on the same oral glucose-lowering medications; a statistically significant mean weight reduction of -3.1 kg (n=25; p=0.010) from baseline; and a statistically significant mean increase of HDL of 6.4 (n=28; p= 0.037) from baseline. Diabetes treatment satisfaction was improved with a statistically significant increase in DTSQc at 24 months post-Revita. Mean levels of LDL, total cholesterol, and triglyceride were not statistically different from baseline to month 24.

"These results from our earlier REVITA-1 study give an encouraging picture of the potential long-term outcomes of Revita on multiple clinical and patient-relevant parameters, including glucose control, weight change, cardiovascular parameters and patient satisfaction,” said Harith Rajagopalan M.D. Ph.D., Fractyl Health Co-Founder and CEO. “We are committed to rigorously evaluating the safety and effectiveness of Revita in patients with T2D across the spectrum of disease with our Revitalize T2D clinical development program.”

About Revita®
Fractyl Health’s lead product candidate, Revita, is based on the company’s insights surrounding the potential role of the gut in metabolic diseases. Revita is designed to remodel the duodenal lining via hydrothermal ablation (i.e., duodenal mucosal resurfacing) to edit abnormal intestinal nutrient sensing and signaling mechanisms that are a potential root cause of metabolic diseases. In April 2016, Revita received a CE mark in Europe. In the United States, Revita is for investigational use only and has received Breakthrough Device Designation from the FDA to improve glycemic control and eliminate insulin needs in T2D patients who are inadequately controlled on 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 utility of Revita in patients with, or at high risk for, T2D. The company’s ongoing pivotal clinical study, Revitalize-1, is designed as a randomized, double-blind crossover, sham-controlled, multi-center study in patients with inadequately controlled T2D despite being on metformin or multiple ADAs, and long-acting insulin. The Revitalize-2 study is a planned profile optimization study in T2D patients who qualify for insulin and are failing guideline-directed therapy. 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 T2D.

About Fractyl Health
Fractyl Health is focused on pioneering a new approach to the treatment of T2D. Despite advances in treatment over the last 50 years, metabolic diseases in general, and T2D in particular, continue to be a principal and rapidly growing driver of morbidity and mortality in the 21st century. Fractyl Health’s goal is to transform T2D treatment from chronic blood glucose management to disease-modifying therapies that target the organ-level root causes of the disease. Fractyl Health’s lead product candidate, Revita, is designed to remodel the duodenal lining via hydrothermal ablation (i.e., duodenal mucosal resurfacing) in order to edit abnormal intestinal nutrient sensing and signaling mechanisms that are a potential root cause of metabolic diseases. Fractyl Health is a private organ-editing metabolic therapeutics company based in Lexington, MA. For more information, visit www.fractyl.com or www.twitter.com/FractylHealth.