Fractyl announced that 39 Type 2 diabetes patients treated using its investigative minimally invasive Revita Duodenal Mucosal Resurfacing System exhibited a reduction in blood sugar levels, mirroring the outcomes achieved via invasive bariatric surgery procedures.
The 28 patients receiving DMR on a long segment of the duodenum experienced a greater reduction in HbA1c levels at 3 months. They achieved a reduction in HbA1c levels from 8.5% to 7.1% at 6 months, and lost about 5 pounds of weight, Fractyl said during the World Congress on Interventional Therapies for Type 2 Diabetes in London. The long-segment DMR patients had a baseline HbA1c level of 7.5% to 10% and were taking diabetes medications during the trial.
As far as procedural safety and adverse events go, the company reported three instances of duodenal stenosis, which were treated using endoscopic balloon dilation.
Dr. Alan Cherrington, professor medicine at Vanderbilt University, presented the data in London. "Patients in this study had poorly controlled Type 2 diabetes, despite medication use," he said, according to the release. "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."
Fractyl is conducting further studies in pursuit of FDA and CE-mark approval. The company said it has enrolled 20 patients in its 50-person open-label study to be conducted in Belgium, the U.K. and Chile. The primary endpoint will be "change in HbA1c in patients with uncontrolled Type 2 diabetes, defined as having poor glucose control on oral medications and an HbA1c of 7.5% to 10%." A double-blind, sham-controlled trial of up to 240 patients will commence in 2016.
The DMR procedure involves altering the body's ability to process sugar by modifying the lining of the small intestine in the duodenum (or duodenal mucosa) using thermal ablation. The duodenum is the part of the small intestine closest to the stomach and produces hormones that control blood sugar.
"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," said Dr. Francesco Rubino, the head of bariatric surgery at King's College London, in a statement. "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."
Last year the company revealed a $40 million Series C financing round led by investment firm Mithril Capital Management. General Catalyst, Bessemer Venture Partners and Domain Associate also participated in the round.
- read the release