Fractyl Laboratories Inc. has announced positive clinical data for the first procedural therapy to directly treat the underlying digestive causes of insulin resistance in patients with uncontrolled type 2 diabetes. The non-invasive Revita™ Duodenal Mucosal Resurfacing™ (DMR) procedure is designed to alter the inner surface of the duodenum and change how the body absorbs and processes sugar. The Revita DMR procedure has the potential to delay the need for insulin therapy and free patients from the burdens associated with managing type 2 diabetes, particularly when oral medications have failed.
According to the results of a single-site pilot study performed in Santiago, Chile, the Revita DMR procedure led to a greater than two percentage-point drop in hemoglobin A1C levels (HbA1c, the key measure of blood glucose control) by three months after the procedure with an excellent safety record. The patients in the study who were followed for up to six months maintained their improved HbA1c levels. These clinical data were presented in late August at the 19th World Congress of International Federation for the Surgery of Obesity & Metabolic Disorders (IFSO 2014) meeting in Montreal, Canada.
Diabetes as a Digestive Disease
In recent years, a significant number of clinical studies have shown an almost immediate improvement in glycemic control following bariatric surgery where the duodenum is either blocked or bypassed. The duodenum, the first portion of the intestine, is where absorption of nutrients begins and hormones that control blood sugar levels are produced.
"The gastrointestinal tract plays a critical role in the regulation of glucose metabolism," said Francesco Rubino, M.D., Professor and Chair of Bariatric and Metabolic Surgery at King's College London. "Chronic exposure to food-borne and environmental toxins could cause disruption to gastrointestinal physiology, possibly explaining the link between modern diets and type 2 diabetes. On the other hand, operations used in bariatric surgery, especially those that involve a bypass of the duodenum, are the only type of treatment known to cause complete and long-term remission of diabetes. This knowledge provides a compelling reason to consider the gut as a physiologic and rational target for the development of more effective therapies of type 2 diabetes."
The company believes that the Revita DMR procedure could be a compelling option for millions of patients, particularly those who are failing oral therapy and are transitioning to complicated drug regimens that may include insulin. Many patients fear insulin injections for their inconvenience and substantial side effects, including pain, weight gain, and risk of hypoglycemia.
The Impact of Revita DMR on Glucose Control
Manoel Galvao Neto, M.D., a bariatric surgeon in Sao Paulo, Brazil, announced the results of the company's proof-of-principal study, demonstrating the safety and effectiveness of the Revita procedure, during an oral presentation at IFSO 2014 on August 29.
Under endoscopic management, Dr. Neto and his team performed thermal ablation of the duodenal mucosa with the Revita System on 30 patients with uncontrolled diabetes and HbA1c levels averaging 9.2 prior to treatment. In the 19 patients who received DMR over several centimeters of their duodenum, HbA1c levels dropped to 7.1, on average, after three months and remained stable six months after the procedure. The treatment effect appears to be dose-dependent, as those patients who received DMR over a shorter segment of their duodenum did not experience as significant of a benefit.
"While early, we believe these results validate our approach and indicate the significant impact that the Revita DMR procedure could have for patients afflicted with type 2 diabetes," said Dr. Rajagopalan, Fractyl CEO. "We are preparing to launch our multinational study by the end of the year and working towards our clinical development efforts in the U.S., which we expect to commence during 2016. We are committed to bringing to market an innovative clinical procedure to improve the health of patients with type 2 diabetes."
Consequences of Poor Diabetic Control
Despite significant effort and numerous drug options, nearly half of the diabetic population in the U.S. and Europe will become poorly controlled. In 2012, these complications associated with high blood sugar levels in patients with type 2 diabetes cost the U.S. healthcare system $245 billion, a 41% increase over the prior five-year period.1 These costs are expected to rise dramatically as the population ages and more people develop the disease.