|Fractyl co-founder and CEO Dr. Harith Rajagopalan|
Fractyl Laboratories has started a sizable clinical trial to test its noninvasive duodenal resurfacing technology as a treatment for insulin resistance in Type 2 diabetes patients. The news comes after the startup garnered a $40 million Series C round from investors including Mithril Capital Management last fall.
The new Revita-1 study for its Revita Duodenal Mucosal Resurfacing (DMR) System involves a 50-patient, 10-site first phase with an eventual double-blinded, sham-controlled second phase that will enroll up to 240 patients. The latter is slated to start next year; the trial will be in Europe and Latin America.
The primary efficacy endpoint of the trial 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 percent. The company has already enrolled more than 10 patients in the trial.
"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 Fractyl co-founder and CEO Dr. Harith Rajagopalan in a statement. "It will also 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." He was an Entrepreneur-in-Residence at venture firm General Catalyst Partners when he helped to found the company.
Fractyl previously disclosed the results of a single-site pilot study in which patients had a more than 2% average decline in in hemoglobin A1C levels (HbA1c), which was maintained at a six-month follow-up.
The DMR technology is based on recent scientific insights regarding the role of intestinal hormones in Type 2 diabetes. It works by resurfacing duodenal mucosa in the intestines with thermal ablation. This is thought to address the intestinal hormonal impairment involved in insulin resistance, which leads to Type 2 diabetes. The procedure doesn't require an implant and is performed endoscopically, so the company is hoping that it can be used widely.
"My center has now 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 Dr. Geltrude Mingrone, a physician participating in the latest trial, in a statement. "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."
- here is the release