Fractyl Laboratories, a private company based in Waltham, Mass., has begun patient enrollment in a multicenter clinical trial (Revita-1) being conducted in Europe and South America to evaluate the safety and performance of the Revita Duodenal Mucosal Resurfacing (DMR) System. Revita is the first non-invasive, implant free duodenal resurfacing procedural therapy designed to directly treat the digestive causes of insulin resistance in patients with uncontrolled type 2 diabetes.
“The Revita-1 study will expand our understanding of the safety and efficacy of the Revita DMR procedure in patients with type 2 diabetes,” said Harith Rajagopalan, M.D., Ph.D., co-founder and CEO of Fractyl. “It also will guide our plans for multi-arm pivotal trials, along with data from our earlier, proof-of-concept human studies that we plan to publish this year.”
More than 10 patients have been treated in the first phase of the Revita-1 study, which will enroll 50 patients across ten international sites. The primary efficacy endpoint is change in HbA1c in patients with uncontrolled type 2 diabetes, defined as having poor glucose control on oral medications and an HbA1c of 7.5% to 10%. The second phase of the study, a double-blinded, sham-controlled trial that will enroll up to 240 patients, will begin in 2016.
“My center now has treated four patients in the Revita 1 trial, and two patients have crossed the one-month threshold and appear to be well satisfied with this minimally invasive procedure,” said Geltrude Mingrone, M.D., Ph.D. “We have known for some time that bariatric surgeries can improve glycemic control independent of weight loss; it will be interesting to see if Revita can offer a safe, less invasive option with similar metabolic benefits.”