Early clinical data from Fractyl Laboratories showed that its 40-minute outpatient procedure aimed at the gut could help eliminate several months’ worth of daily insulin injections for people with Type 2 diabetes.
The former Fierce 15 winner’s endoscopic Revita DMR procedure—for “duodenal mucosal resurfacing”—uses water and heat to strip away the inner lining of a portion of the small intestine, allowing it to regrow naturally.
This rejuvenating process seeks to reset the constant production of hormones within that part of the organ, the lion’s share of which are linked to metabolism and related diseases.
Years of dietary fats, sugars and other foods can cause the mucosal lining of the duodenum to become too thick, the company says, leading to imbalances and feedback loops that can contribute to insulin resistance, diabetes and other metabolic syndromes—including non-alcoholic fatty liver disease and steatohepatitis, known as NAFLD and NASH.
The therapy was inspired by the surprising results of certain gastric bypass surgeries for weight loss, which showed an almost immediate reversal of Type 2 diabetes when food was routed around the duodenum.
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“This reversal was also totally weight independent, which was really striking and goes against everything that we learned in medical school about why you develop Type 2 diabetes or other metabolic diseases,” Fractyl co-founder and CEO Harith Rajagopalan told FierceMedTech.
“Because the way that we were taught is that you gain weight, and you become obese, and then that obesity causes you to get Type 2 diabetes—but here is the surgery where the diabetes is going away before people have even lost any weight,” Rajagopalan said.
In the company’s interim study results, presented at the annual Scientific Sessions of the American Diabetes Association in San Francisco, 11 out of 13 patients—with an average history of Type 2 diabetes spanning 10 years—reported being insulin-free after at least six months. Three additional participants have not yet reached the six-month mark.
The participants continued therapy with a GLP-1 agonist, with some not needing insulin injections for as long as a year. Additionally, patients saw a nearly 45% reduction in liver fat on an MRI scan plus improvements in weight and blood pressure, the company said.
“Type 2 diabetes is complicated with many severe comorbidities, often managed with multiple daily medications. But with Revita DMR, we continue to see positive clinical effects on diabetes, fatty liver and cardiovascular disease after treatment,” said Juan Carlos Lopez-Talavera, Fractyl’s chief medical officer.
A healthy mucosal layer regrows within one to two months following the procedure, though the beneficial effects appear to be lasting much longer than that, Rajagopalan said.
“Time will tell whether this procedure needs be repeated and at what frequency, but so far, I think it's reasonable to say that the effects continue to look very promising one year after the procedure,” he said—with one of the most profound improvements being seen in quality-of-life and management of the disease by moving patients from calculating daily injections onto a fixed set of medications.
A separate, sham-controlled study is being currently performed in more than 100 patients with poorly controlled diabetes despite a number of treatments but are not yet receiving insulin.
Data from that randomized trial are expected later this summer. Combined with the results from the smaller study, Fractyl aims to use the two trials to help commercialize its CE marked Revita procedure outside the U.S., while also filing for pivotal studies with the FDA.
Earlier this year, the company presented NAFLD and NASH-focused data at the International Liver Congress in Vienna. In that study, measurements of liver fat were reduced by 36%, with 88% of patients showing improvements in both liver fat and glucose levels within three months of treatment.
Fractyl describes NAFLD, NASH and Type 2 diabetes reaching epidemic levels in the U.S. and internationally, with about 18 million Americans estimated to have more than one of the conditions.