Fractyl Laboratories touted data today showing sustained improvement in glycemic parameters after one year following a single treatment with its Revita duodenal mucosal resurfacing system in patients with Type II diabetes.
“This is the first presentation of one-year data on the durability of the Revita DMR procedure in Type II diabetes. The Revita DMR procedure was well tolerated, and no serious adverse events related to the device or procedure were reported through one-year of follow up,” co-founder & CEO Dr. Harith Rajagopalan said in prepared remarks. “Additional data on the durability of this intervention’s effects on liver measures in patients with Type II diabetes will also be presented at AASLD later this year.”
The company’s minimally-invasive procedure is designed to rejuvenate the surface of the duodenum to address insulin resistance.
Data from the Revita-1 study showed that a single DMR procedure resulted in sustained reductions in HbA1c, fasting glucose and markers of insulin resistance after one year.
“While there are an increasing number of pharmacological treatments for Type II diabetes, these have little impact on the natural history of the disease and create a significant treatment burden for the patient,” Dr. David Hopkins, director of the Institute of Diabetes, Endocrinology, and Obesity at King’s Health Partners, added. “These data, showing durable improvements in insulin resistance (HOMA-IR) and glycemic control observed over a year, demonstrate the potential for Revita DMR to impact the mechanisms underlying Type II diabetes through a single same-day procedure indicating considerable potential as an alternative approach to escalating drug treatment.”
Fractyl is also enrolling patients in Europe in its Revita-2 trial, which is designed to evaluate the safety and efficacy of the Revita DMR system in orally-treated Type II diabetes patients, the company reported.