Hydrothermal duodenal mucosal resurfacing results published in current issue of Diabetes Care
Fractyl Laboratories Inc. (Fractyl) announced today publication of data in the current issue of Diabetes Care from the Company’s first-in-human study of RevitaTM duodenal mucosal resurfacing (Revita DMR). “Endoscopic Duodenal Mucosal Resurfacing for the Treatment of Type 2 Diabetes: 6-Month Interim Analysis from the First-in-Human Proof-of-Concept Study” is the first comprehensive analysis and publication of data from 39 patients in the first-in-human Revita DMR trial. The results showed a significant improvement in hyperglycaemia in patients with type 2 diabetes poorly controlled on one or more oral antidiabetic agents (screening HbA1c: 9.5%). Overall, Revita DMR was well tolerated with minimal gastrointestinal symptoms post procedure. In the study, DMR significantly improved glycaemic control in patients with type 2 diabetes, with a predominant effect of lowering fasting hyperglycaemia, suggestive of a potential insulin-sensitising mechanism.
“This is the first peer-reviewed publication of human clinical data from the proof-of-concept trial,” said Harith Rajagopalan, MD, PhD, Co-Founder and CEO of Fractyl. “This study is part of a growing body of evidence that suggests Revita DMR may address the underlying metabolic complications of insulin resistance and could represent a new treatment for option for patients with type 2 diabetes who are failing oral medications or have evidence of fatty liver disease.”
Revita DMR is a trans-oral procedure targeting the duodenum, a portion of the intestine that plays an important role in regulating insulin sensitivity and metabolic homeostasis. Using proprietary balloon catheters, Revita DMR uses a combination of circumferential mucosal lift and hydrothermal ablation to rejuvenate the surface of the duodenum and potentially alter gut signalling in patients with metabolic diseases driven by insulin resistance. It is designed to be a short (< 60 min) procedure with the potential to restore metabolic health while avoiding many of the challenges patients and physicians face managing complicated medical regimens. A 50-patient, multicentre, international clinical trial is currently underway in patients with type 2 diabetes, in which 40 patients have already been treated across sites in the United Kingdom, Chile, Italy, Netherlands and Belgium.
“The gastrointestinal tract plays a major role in the physiologic regulation of glucose metabolism, so it is plausible that gastrointestinal changes in response to years of exposure to certain foods might contribute to the development of metabolic diseases, especially type 2 diabetes,” said Francesco Rubino, MD, Chair of Bariatric Surgery at King’s College London and Consultant Surgeon at King’s College Hospital in London, UK. “There is now a solid biological rationale to consider the gastrointestinal tract as an ideal target for anti-diabetes interventions. In fact, recently recognised new guidelines from international diabetes organisations recommend the use of gastrointestinal surgery as a standard treatment option in certain patients with type 2 diabetes. However, because surgery is not suitable as mass treatment for the hundreds of millions of patients suffering from diabetes, less invasive approaches that harness the mechanisms of major surgery and reproduce some of its beneficial effects could provide a real opportunity for improvement of diabetes care. The early results with Revita DMR are quite encouraging in this regard.”
In other company news, Fractyl announced the opening of a new, 30,000-square-foot headquarters in Lexington, MA. The site includes dedicated research and manufacturing facilities. The company also announced that David Maggs, MD, has joined the company as Chief Medical Officer and Nimesh Shah has joined the company as Chief Business Officer.