Two-year durability data from the REVITA-1 clinical study, conducted at centres in Europe and South America, revealed that HbA1c was observed to be statistically significantly reduced at all time points in patients who underwent the duodenal lining via hydrothermal ablation (i.e., duodenal mucosal resurfacing, DMR). In addition, patients also reported broader measures of metabolic control, including reductions in weight and improvements in patient self-reported diabetes treatment satisfaction questionnaires (DTSQc). The outcomes, ‘Durable Metabolic Improvements 2 Years After Duodenal Mucosal Resurfacing (DMR) in Patients with Type 2 Diabetes (REVITA-1 Study)’, appeared in Diabetes Research and Clinical Practice.
“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 Dr David Hopkins, 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.”
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 duodenal mucosal resurfacing is designed to edit abnormal intestinal nutrient sensing and signaling mechanisms that are a potential root cause of metabolic diseases.
REVITA-1 was an open-label feasibility study of Revita in subjects with poorly controlled type 2 diabetesm 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:
In long-term safety follow-up, there were no treatment-related adverse events 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 hypoglycaemic events were observed between month six and month 24.
At 24 months following a single Revita procedure, the researchers 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 -3.1kg (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 Dr Harith Rajagopalan, 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.”
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, type 2 diabetes. The company’s ongoing pivotal clinical study, Revitalize-1, is designed as a randomised, double-blind crossover, sham-controlled, multi-centre 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.
Separately, the Revita DMR System (Revita) has gained reimbursement authorisation from the German Institute for Hospital Remuneration (InEK) with a NUB Status 1 designation, entitling participating hospitals in Germany to begin to negotiate payment for Revita from statutory health insurers. German hospitals may now negotiate full reimbursement from the national health insurance system for its use in their patients in clinical studies and/or real-world evidence generation in a commercial setting.
“The challenge of T2D in Germany is continuously growing, and recent research advances have not reduced its endemic proportions. The need for new therapies has never been greater,” said Professor Markus Lerch, President of the German Society for Internal Medicine. “A novel endoscopic approach that addresses a completely different pathophysiological mechanism of T2D could potentially change the landscape of our therapeutic arsenal.”
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 glycaemic control and eliminate insulin needs in T2D patients who are inadequately controlled on long-acting insulin.