Fractyl Labs touts data from Revita study

Fractyl Labs said yesterday that a study of its Revita duodenal mucosal resurfacing system reported significant changes in blood sugar in type 2 diabetes patients, similar to those seen with bariatric surgery procedures.

Data from the study was presented at the 3rd World Congress on Interventional Therapies for Type 2 Diabetes in London this week, Waltham, Mass.-based Fractyl said.

The Revita device is designed to ablate the duodenum (the 1st part of the intestine) in order to alter glucose metabolism. Fractyl calls its approach the “1st procedural therapy to treat type 2 diabetes.”

“I appreciate having the opportunity to present our data. Patients in this study had poorly controlled type 2 diabetes, despite medication use. They experienced a significant improvement in HbA1c after this minimally invasive procedure, as well as some weight loss. With this study, we continue to see evidence that the biology of the intestine plays a very important role in type 2 diabetes pathology, and that altering it can meaningfully improve blood sugar control,” Dr. Alan Cherrington of Vanderbilt University said in a press release.

The 39-patient proof-of-concept study had primary endpoints of patient safety and reduction in HbA1c after 6 months, and examined patients with “poorly controlled” type 2 diabetes. Patients were treated with either a long-segment or short-segment DMR procedure.

The study reported that patients treated with the long-segment treatment showed better improvement in baseline HbA1c at 3-months post procedure compared to those treated with short-segment DMR. Patients in the long-segment DMR cohort reported a decrease in HbA1c from 8.5% to 7.1% and a 5 lb reduction in weight. The company said there was no apparent correlation between weight loss and HbA1c improvement.

“Earlier this month, our team published a 5-year follow-up study showing that surgery may be more effective than standard medical treatments for the long-term control of type 2 diabetes in obese patients. This is a huge shift in how we think about the disease. It will be exciting to see if these early results using a much less invasive duodenal mucosal resurfacing approach will be reproduced in larger studies,” Dr. Francesco Rubino of King’s College in London said in prepared remarks.

Three patients experienced duodenal stenosis that required endoscopic balloon dilation, but did not result in serious adverse events.

“These results are helpful as we design our path to market, including pivotal trials in Europe and the United States. It is exciting to have our data presented at WCITT2D in context of the spectrum of novel intervention therapies for type 2 diabetes,” CEO Dr. Harith Rajagopalan said in a prepared statement.

In July, Fractyl said it enrolled the 1st patients in a separate trial of its Revita duodenal mucosal resurfacing system designed to treat the digestive causes of insulin resistance in patients with type 2 diabetes.

More than 10 patients have been enrolled and treated in the 1st phase of the Revita-1 study, which is slated to enroll 50 patients across 10 sites. The study seeks to explore changes in HbA1c in patients with diabetes who have poor glucose control on oral medications, Fractyl said.

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