Data Show Positive Results for Fractyl’s Duodenal Mucosal Resurfacing Device

Fractyl Laboratories Inc. (Fractyl) announced the publication of data from the company’s first-in-human study of Revita 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 hyperglycemia in patients with type 2 diabetes poorly controlled on one or more oral antidiabetic agents (screening HbA1c: 9.5 percent). Overall, Revita DMR was well tolerated with minimal gastrointestinal symptoms post procedure. In the study, DMR significantly improved glycemic control in patients with type 2 diabetes, with a predominant effect of lowering fasting hyperglycemia, suggestive of a potential insulin-sensitizing mechanism.
 
“This is the first peer-reviewed publication of human clinical data from the proof-of-concept trial,” said Harith Rajagopalan, M.D., Ph.D., 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 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 signaling in patients with metabolic diseases driven by insulin resistance. It is designed to be a short (less than 60 minutes) 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, multicenter, 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, M.D., chair of bariatric surgery at King’s College London and Consultant Surgeon at King’s College Hospital in London, United Kingdom. “There is now a solid biological rationale to consider the gastrointestinal tract as an ideal target for anti-diabetes interventions. In fact, recently recognized new guidelines from international diabetes organizations 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, Mass. The site includes dedicated research and manufacturing facilities. The company also announced that David Maggs, M.D., has joined the company as chief medical officer and Nimesh Shah has joined the company as chief business officer.
 
Type 2 diabetes and nonalcoholic fatty liver disease (NAFLD) are two of the most prevalent metabolic diseases around the world. In both type 2 diabetes and NAFLD, insulin resistance is a key driver of the disease process. Type 2 diabetes is characterized by hyperglycemia resulting from the resistance of the body to insulin and failure of the pancreas to produce sufficient insulin to meet the body’s needs. NAFLD is a condition in which fat accumulates in the liver, and represents an important manifestation of metabolic disease in the liver. NAFLD can progress to nonalcoholic steatohepatitis (NASH) and lead to liver inflammation and fibrosis, which can place NASH patients at higher risk of developing cirrhosis, liver failure and liver cancer.
 
Approximately 50 percent of patients with NASH also have type 2 diabetes, and there are currently no available pharmaceutical or procedural therapies specifically approved for NAFLD or NASH.
 
Fractyl Laboratories is a private medical technology company based in Lexington, Mass., that is developing Revita DMR, a same-day, minimally invasive procedure to treat two highly prevalent metabolic diseases: type 2 diabetes and NAFLD/NASH. The Revita DMR procedure harnesses current insights from bariatric science to address insulin resistance at its source. The Revita DMR procedure and device are currently being evaluated in clinical trials. The Revita DMR System received European CE Mark approval in April.