Fractyl Laboratories made a pretty bold statement with its interim data from the INSPIRE trial at the American Diabetes Association's 79th Scientific Sessions in San Francisco this past weekend.

The investigator-initiated INSPIRE clinical study showed that Fractyl’s Revita Duodenal Mucosal Resurfacing (DMR) System can help eliminate the need for daily insulin injections for type 2 diabetes patients.

“[Revita DMR] … is now showing real promising efficacy in patients who are taking daily injections for their type 2 diabetes already,” Harith Rajagopalan, MD, PhD, co-founder and CEO of Fractyl told MD+DI. “Unlike our prior trials, which have focused on the cusp of patients needing insulin, where the question is can Revita DMR help improve glucose control and delay or prevent the need for insulin – [INSPIRE] is a trial for people already on insulin, asking can patients discontinue insulin successfully after our procedure.”

Revita DMR is a same-day, outpatient endoscopic treatment that uses heat to resurface the lining of the upper intestine (duodenum) in a minimally invasive, outpatient procedure.

The INSPIRE study completed enrollment at 16 patients, out of which 13 patients have reached the six-month follow-up, and 11 of 13 (85%) are insulin-free. The remaining three patients are still in the trial but have not reached their six-month follow-up for this interim analysis.

“If you’re a patient with type 2 diabetes and your blood sugar is poorly-controlled, and you’re already taking insulin, then it’s pretty clear what your future therapeutic options look like,” Rajagopalan said. “It means more insulin; multiple daily injections of insulin; and maybe even an insulin pump at some point in the future. This means more engagement with the act of management of your condition and more and more insulin. What this study shows is that there might be an alternative that can in a sense dial back the clock and get patients to a place where they can get their blood sugar under better control and not need to take insulin anymore.”

INSPIRE also shows that 45% reduction in liver fat on MRI-PDFF (from a baseline of 8.5% absolute liver fat), along with significant improvements in blood pressure and weight.

“In addition to getting patients off of insulin, and in addition to getting their blood sugar under better control; this trial is showing remarkable benefit in other aspects of the metabolic syndrome that all of these patients experience,” Rajagopalan said. “There are improvements in blood pressure; there are improvements in cholesterol and there are improvements in fatty liver disease, which is a precursor to nonalcoholic steatohepatitis [NASH]– the leading cause of liver failure in the U.S.”

Previous clinical studies of Revita DMR in more than 200 patients have demonstrated sustained improvements in blood glucose levels, insulin resistance measures, liver fat, cardiovascular risk markers, and weight loss, unaided by any lifestyle intervention, through one year of follow-up. In all clinical studies, Revita DMR was well-tolerated and demonstrated an acceptable safety profile.

The next steps for the company will be securing the necessary regulatory approvals in the U.S. It should be noted that the procedure received CE mark in 2016.

“We have two-randomized double-blinded sham-controlled studies that are going to be reporting data later in the summer,” he said. “One of them is called the Revita 2 Trial. “The results of that study will inform the pivotal study that we will file in type 2 diabetes and fatty liver disease.”