Fractyl Health announced today that it received FDA approval for an investigational device exemption (IDE) trial of its diabetes reversal platform.
Lexington, Massachusetts-based Fractyl Health will evaluate its Revita treatment in patients with type 2 diabetes whose disease is inadequately controlled despite treatment with at least two antidiabetic agents (ADAs) and who are not yet on insulin in the Revitalize-2 IDE pivotal study.
According to a news release, the prospective, randomized, double-blind, sham-controlled study will enroll up to 510 patients across up to 35 sites around the world, including approximately 25 locations in the U.S. It will examine the effect of Revita on improving glycemic control and preventing the need for insulin, with a primary endpoint of change in HbA1c (reflecting the degree of glycemic control) with Revita compared to a sham treatment arm.
“We are delighted the FDA has granted this IDE allowing Fractyl Health to begin a second pivotal clinical study evaluating Revita DMR in a high unmet need T2D patient population that is looking for an alternative to insulin therapy,” Fractyl Health CMO Dr. Juan Carlos Lopez-Talavera said in the release. “Alongside our ongoing Revitalize-1 study for patients who are already on insulin, Revitalize-2 has potential for patients whose disease is inadequately controlled on multiple antidiabetic agents and who may benefit from a non-drug option to address the root cause of their disease.”
Fractyl Health’s Revita duodenal mucosal resurfacing (DMR) procedure has been tested in early pilot clinical studies in approximately 300 patients with various stages of type 2 diabetes, the company said.
Its Revitalize T2D clinical development program aims to encompass multiple parallel ongoing and planned clinical studies testing the use of Revita in different populations, covering a range from those with prediabetes to those with type 2 diabetes on long-acting insulin. Revitalize-1, which earlier this year reported positive two-year durability data, is the first of these studies and is still actively enrolling insulin-treated patients in multiple U.S. and European locations.
“We believe there is considerable potential to intervene in gut dysfunction in a manner that may prevent disease progression or the development of T2D altogether,” Fractyl Health co-founder and CEO Dr. Harith Rajagopalan said. “We see the Revitalize-2 pivotal study as an important step in the journey for Revita in patients with T2D and potentially prediabetes as well.”