Fractyl Laboratories presented new data from two trials of its intestine-resurfacing procedure, including one demonstrating improvements in both blood glucose control and liver fat among Type 2 diabetes patients with and without nonalcoholic fatty liver disease.
The second study illustrated durable benefits in HbA1c reduction for up to two years after a single outpatient treatment. The former Fierce 15 winner’s endoscopic Revita device and procedure uses water and heat to strip away the inner lining of the small intestine’s duodenum, allowing it to regrow naturally.
That mucosal lining can thicken after years of exposure to dietary fats, sugars and other foods. The company believes its rejuvenating process can reset the balance of hormones produced within that part of the organ, many of which are linked to metabolic pathways and related diseases as well as insulin resistance.
Fractyl’s first multicenter, sham-controlled clinical study tested a procedure that ablated a length of 10 centimeters within the duodenum, across the organ’s entire inside circumference. For the two weeks following, patients received a controlled diet that escalated from liquids to semi-solids to solid foods.
After 24 weeks, the Revita procedure showed a reduction of 0.8 percentage points in HbA1c and a 32% reduction in liver fat content measured by MRI.
Meanwhile, patients with a higher fasting plasma glucose at the study’s baseline saw a 1.2% reduction in HbA1c, and improvements in weight loss, liver insulin sensitivity and pancreatic beta-cell function were also observed, the company said. The results were presented in a late-breaking oral presentation at the annual meeting of the American Association for the Study of Liver Disease in Boston.
The second, long-term study, presented at the Diabetes Technology Meeting in Bethesda, Maryland, showed a full percentage point reduction in HbA1c after two years, from 8.5% to 7.5%, among 34 patients with Type 2 diabetes.
Improvements in liver biomarkers were also seen over the same period, Fractyl said, alongside an 80% response rate. Additionally, patient satisfaction scores were improved at 12 months, and no adverse events attributed to Revita were observed, the company said.