Fractyl Announces Initiation of Multicenter Clinical Trial to Evaluate a Novel Medical Procedure for Poorly Controlled Type 2 Diabetes
LEXINGTON, Mass. – May 23, 2017 – Fractyl Laboratories Inc.
) today announced that the first patient in Europe has been treated as part of a 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.
Recent discoveries in metabolic science are now demonstrating that lifestyle and diet induced changes to the lining of the first segment of the small intestine (the duodenum) can lead to insulin resistance and are associated with metabolic disorders such as type 2 diabetes and nonalcoholic steatohepatitis (NASH).
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 clinical data we have gathered to-date suggests Revita™ DMR may address a significant unmet medical need, which is the underlying insulin resistance in patients with type 2 diabetes who are poorly controlled despite medications,” said Harith Rajagopalan, M.D., Ph.D., cofounder and CEO of Fractyl. “We anticipate that the Revita-2 trial will further build the clinical support about the safety and efficacy of the Revita DMR procedure and inform the design of additional clinical trials.”
The Revita-2 clinical trial is a randomized, sham-controlled, blinded study performed at multiple centers in Europe and will include three month glycemic and hepatic endpoints. Revita-2 follows the completion of Revita-1, which was an open-label study that enrolled 50 patients across multiple international sites. Data from Revita-1 will be made available at select upcoming international medical meetings.
“Untreated insulin resistance can lead to more severe diseases including fatty liver disease and NASH,” said Jacques Devière, Head of Gastroenterology at the Hôpital Erasme in Brussels. “The initial clinical data of Revita™ DMR is encouraging, and there is enormous need for treatments that can change the course of these metabolic diseases.”
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
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