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LEXINGTON, Mass., Sept. 12, 2017 /PRNewswire/ -- Fractyl Laboratories Inc. (Fractyl) and clinical investigators for the Revita-1 clinical trial today report one-year data from the study showing sustained improvement in glycemic parameters following a single treatment with Revita™ DMR in patients with type 2 diabetes (T2D). The data will be presented at the 53rd Annual Meeting of the European Association for the Study of Diabetes (EASD) in Lisbon, Portugal.
"This is the first presentation of one-year data on the durability of the Revita DMR procedure in type 2 diabetes. The Revita DMR procedure was well tolerated, and no serious adverse events related to the device or procedure were reported through one-year of follow up," said Harith Rajagopalan, M.D., Ph.D., cofounder and CEO of Fractyl. "Additional data on the durability of this intervention's effects on liver measures in patients with type 2 diabetes will also be presented at AASLD later this year."
Revita DMR is a minimally invasive, therapeutic procedure designed to rejuvenate the duodenum. It is intended as an outpatient therapy to be performed in less than one hour and allow patients to resume normal activities the following day. By rejuvenating the surface of the duodenum, Revita DMR is designed to address insulin resistance directly and help improve the management of type 2 diabetes.
The data from Revita-1, a single arm, open label, multicenter study, reports that a single DMR procedure produced sustained reductions in HbA1c, fasting glucose, and markers of insulin resistance (HOMA-IR) out to at least 12 months. A larger, randomized, multicenter, sham-controlled, blinded study is currently underway in Europe to further evaluate the safety and efficacy of the Revita DMR System in orally-treated type 2 diabetes patients with poorly controlled disease.
"While there are an increasing number of pharmacological treatments for type 2 diabetes, these have little impact on the natural history of the disease and create a significant treatment burden for the patient," said Dr. David Hopkins, director of the Institute of Diabetes, Endocrinology, and Obesity at King's Health Partners, London. "These data, showing durable improvements in insulin resistance (HOMA-IR) and glycemic control observed over a year, demonstrate the potential for Revita DMR to impact the mechanisms underlying type 2 diabetes through a single same-day procedure indicating considerable potential as an alternative approach to escalating drug treatment."
The poster (PS 860) entitled, "Duodenal Mucosal Rejuvenating (DMR) Demonstrates Sustained Improvement in Glycaemic Parameters in Type 2 Diabetes (T2D): 12 Month Data" will be presented on Tuesday, September 12th at 13:15 to 14:15 CET during the poster session, Novel Approaches to Glycaemic Control.
Fractyl is currently enrolling patients in Europe in a multi-center clinical trial called Revita-2. The trial is designed to evaluate the safety and efficacy of the Revita DMR System in orally-treated type 2 diabetes patients with poorly controlled disease. For more information, please visit https://clinicaltrials.gov/ct2/show/NCT02879383.
About Insulin Resistance and Metabolic Diseases
The term "metabolic disease" refers to a broad group of conditions in which the body's normal metabolic processes become disordered. The most common metabolic diseases—type 2 diabetes and nonalcoholic fatty liver disease / nonalcoholic steatohepatitis (NAFLD/NASH)—occur as a result of insulin resistance. Type 2 diabetes is characterized by hyperglycemia resulting from insulin resistance and the resulting failure of the pancreas to produce sufficient insulin to meet the body's needs. NAFLD is a condition in which fat accumulates in the liver, also caused by insulin resistance, and represents an important manifestation of metabolic disease in the liver. NAFLD can progress to NASH and lead to liver inflammation and fibrosis, which can place NASH patients at higher risk of developing cirrhosis, liver failure and liver cancer.
About Fractyl and Revita™ DMR
Fractyl Laboratories is a private medical technology company based in Lexington, Mass. Fractyl is developing Revita DMR, a same-day, minimally-invasive procedure to treat two highly prevalent metabolic diseases: type 2 diabetes and NAFLD/NASH. The Revita DMR procedure harnesses current insights from bariatric science to address a root cause of insulin resistance in the duodenum. Fractyl's approach aims to improve the health of patients with metabolic diseases with device-based interventions for patients and healthcare systems. The Revita DMR System received a CE mark in the European Union in April 2016. It has not been approved for investigational use by the Food and Drug Administration in the United States. The Revita DMR System may be available for investigational use in other regions. For more information, visit www.fractyl.com or www.twitter.com/FractylLabs.
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