Fractyl Laboratories has enrolled the first patient in a pivotal study of its treatment that is poised to eliminate the need for daily insulin.
The Lexington, MA-based company said the REVITA-T2Di, will evaluate the ability of a single Revita DMR treatment to allow patients currently on insulin therapy but with inadequate glycemic control to achieve durable insulin-free glycemic control.
Revita T2Di is a prospective, randomized, double-blind, sham-controlled study enrolling 300 patients at up to 35 sites around the world, with about 35 sites in the U.S. The pivotal study’s first site is at Indiana University Health.
The trial’s primary endpoint is 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.
Revita uses thermal ablation to ablate a portion of the duodenum mucosa, which executives believe can improve glucose control in patients struggling to manage the disease.
“By targeting the root cause of type 2 diabetes in the intestine, our preliminary clinical findings suggest that treatment with Revita DMR may be able to decrease insulin resistance,”said Juan Carlos Lopez-Talavera, M.D., Ph.D., Chief Medical Officer of Fractyl. “If these data are borne out in the REVITA-T2Di trial, Revita DMR may, in the future, represent an additional option for addressing the significant health and economic burden of type 2 diabetes for patients, healthcare systems, and society at large.”
Fractyl made significant progress in 2020. In August, the company raised $55 million in a series E round to support the REVITA-T2Di pivotal trial. About two months before the financing, Fractyl won FDA approval for the pivotal trial.
The company won CE mark for Revita in 2016.