Fractyl Laboratories is seeking to ‘turn back the clock’ in Type 2 diabetes progression with its disease-modifying therapy.

FDA granted the Lexington, MA-based company IDE to launch a pivotal trial of the Revita DMR, a which holds the potential to eliminate the need for insulin injections in patients suffering from Type 2 diabetes.

“Insulin is a challenging drug for patients with Type 2 diabetes because it can cause weight gain,” Harith Rajagopalan M.D. Ph.D., co-founder and CEO of Fractyl told MD+DI. “It can cause a risk of your blood sugar to drop too low (hypoglycemia); it can carry a stigma of injecting yourself with insulin, and can add a lot of burden to daily disease management.

He added, “Revita’s initial pivotal trial indication is to test the ability of the device to get patients off of insulin and back on to oral medications.”

The pivotal trial is called Revita T2Di and is a prospective, randomized, double-blind, sham-controlled study enrolling 300 patients at up to 35 sites around the world, with approximately 25 sites in the U.S.

Patients who have inadequately controlled T2D despite taking both oral drugs and insulin injections as well as adopting lifestyle changes will be enrolled in the trial. The primary endpoint of the study will be the percentage of patients who are able to achieve target glycemic control (HbA1c less than or equal to 7%) without the need for insulin at 24 weeks, comparing Revita DMR to the sham arm.

Fractyl won CE mark for Revita in 2016.

“Earlier this year, we signed a historic contract with the HCA Hospital in the UK to offer Revita Commercially to patients,” Rajagopalan said. “Just as we were going to launch that service offering in partnership with HCA COVID-19 swept through the world and Europe. Elective procedures were halted. So, we have paused our commercial activities while we wait for the situation to clear.”

Because of the impact COVID-19, the company isn’t giving guidance on a timetable for its pivotal trial other than to say it could start at the end of this year.

Rajagopalan said, “I think it’s a bit early to prognosticate on how our phased-reopening in the U.S. is going to affect what our situation is going to look like in 3Q20 and 4Q20; what impact a second wave might have; what impact this disease has on hospitals backlog; and the need to catch up on really important procedures that affect health.”