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Fractyl Announces New REVITA-2 Study Clinical Data

Fractyl Laboratories Inc. today announced clinical data that elucidate the mechanisms behind the beneficial effects and significant improvements in metabolic disease parameters for type 2 diabetes patients after one Revita® duodenal mucosal resurfacing (DMR) treatment. The data, including results from a mixed meal tolerance test, was accepted for presentation at the Endocrine Society’s annual meeting, ENDO 2020 (canceled due to the COVID-19 pandemic) and will be published in a special supplemental section of the Journal of the Endocrine Society. This clinical data was featured as a “Breakthrough in Diabetes” at today’s webcast news conference hosted by the Endocrine Society.

Previous results from the REVITA-2 study, a randomized, sham-controlled clinical trial, presented at AASLD 2019 and recognized there as ‘Best of the Liver 2019,’ have shown that Revita treatment lowers blood glucose (HbA1c) and reduces liver fat in patients with type 2 diabetes and non-alcoholic fatty liver disease (NAFLD) compared to a sham procedure. For the sham, the Revita catheter was inserted into the intestine but no treatment was performed. All patients underwent a graduated diet for two weeks after the intervention per protocol. Neither the patients nor the endocrinologist knew which treatment the patients received.

As part of the REVITA-2 study, 70 patients with inadequately controlled type 2 diabetes on oral anti-diabetic medications (OADs) also took part in an additional evaluation called the mixed meal tolerance test (MMTT), which helps determine insulin sensitivity and pancreatic beta cell function. The MMTT was performed at baseline and three months after treatment in these patients. Compared with those receiving a sham procedure, patients who received the Revita treatment had significantly lowered glucose levels, primarily driven by decreased fasting blood glucose levels. The average fasting glucose level fell by 41 mg/dL in the Revita-treated group, whereas in the sham group, it only dropped by 15 mg/dL. Improvements in insulin sensitivity and pancreatic beta-cell responsiveness to a meal were also observed in patients who received the Revita treatment compared to those that received the sham treatment.

David Hopkins, MB.Ch.B. (M.D.), director of the Institute of Diabetes, Endocrinology and Obesity, King’s Health Partners in London, the U.K. and REVITA-2 study investigator, said, “This data verifies the gut’s critical role as a root cause of metabolic disease and as an important therapeutic target for type 2 diabetes. Revita leverages many of the benefits of bariatric surgery on glucose metabolism but as a minimally-invasive, outpatient procedure, it is a potential solution for millions of patients. With these data, we show that Revita can change the trajectory of disease by addressing the underlying insulin resistance that causes the progressive failure of the pancreatic beta cells. It’s a major step forward in the development of a disease-modifying treatment for type 2 diabetes.”

David Ehrmann, Professor of Medicine, University of Chicago, and a member of the Writing Committee for the Restoring Insulin Secretion (RISE) study, commented, “From the RISE study, it was disappointing to see that none of the drugs currently approved to treat type 2 diabetes could reverse pancreatic beta-cell failure and, thus, could not stop disease progression. RISE results raise the question as to whether currently available pharmacologic agents will be able to fundamentally alter the trajectory of metabolic disease. These data from a completely innovative, minimally-invasive treatment provide hope that we will have the capability to help our patients improve and possibly mitigate the complications of diabetes instead of managing its symptoms with medications.”

Harith Rajagopalan, M.D., Ph.D., co-founder and CEO of Fractyl, said, “The data from the REVITA-2 clinical study presented here builds on what we previously presented this past November at AASLD to show that one Revita treatment in the gut can improve the health and function of both the pancreas and the liver. It further confirms that by intervening in gut biology we can reverse both progressive beta-cell deterioration and insulin resistance, which has implications for treating a number of metabolic diseases. Now, across hundreds of patients and several clinical studies in patients who have received Revita treatment, we have seen consistent and significant efficacy with an excellent safety profile. With two-year durability data, and now confirmation that Revita DMR is a disease-modifying therapy that can reverse insulin resistance, we are in a prime position to initiate our U.S. pivotal trial and accelerate global commercialization.”


Reference

JAMA Internal Medicine, August 2019, doi:10.1001/jamainternmed.2019.2396

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