Interim clinical data to be presented at ADA 2019 show that approximately 85 percent of patients are insulin-free at six months after Revita DMR outpatient therapy
LEXINGTON, Mass., June 8, 2019 — Fractyl Laboratories Inc. (Fractyl), today announced the presentation of interim data from the investigator-initiated INSPIRE clinical trial in collaboration with Fractyl showing Revita™ DMR, a same-day therapeutic procedure, can help eliminate the need for daily insulin injections for type 2 diabetes (T2D) patients. This data will be presented at the American Diabetes Association’s 79th Scientific Sessions in San Francisco on Sunday, June 9 from 12 pm to 1 pm. The presentation (1156-P) is entitled, “Duodenal Mucosal Resurfacing (DMR) Combined with GLP-1-RA May Eliminate Insulin Therapy and Improve Metabolic Health in Type 2 Diabetes.”
“Other than extreme interventions, this is the first same-day treatment that has the potential to free patients with advanced type 2 diabetes from daily insulin injections,” said Jacques Bergman, M.D., Ph.D., a professor of gastroenterology at Amsterdam UMC and principal investigator of the INSPIRE study. “Our results suggest we can use a straightforward and safe outpatient procedure to eliminate the need for daily insulin, which could have a meaningful positive impact on the hundreds of millions of people across the world suffering from type 2 diabetes.”
Building on years of research about the gut’s critical role as a root cause of metabolicdisease, the Revita duodenal mucosal resurfacing (DMR) procedure aims to reset key metabolic pathways, including insulin resistance, to prevent and even reverse metabolic disease progression. This same-day, outpatient endoscopic procedure uses heat to resurface the lining of the upper intestine (duodenum) in a minimally invasive, outpatient procedure. The therapy is designed to target the root cause of metabolic syndrome in theduodenum, leading to significant improvements in metabolic disease parameters, reduced need for medication usage, and greater patient satisfaction with their therapy.
“An important recent trend is that we now know we can reverse type 2 diabetes with different approaches. The outstanding takeaway from this data is that patients are returning to better overall metabolic health from an outpatient procedure, with reductions in blood sugar, significantly reduced liver fat in NAFLD/NASH, and improved cardiovascular risk parameters even as patients discontinue insulin usage,” said Harith Rajagopalan, M.D., Ph.D., co-founder and CEO of Fractyl. “Revita DMR is helping patients regain control of their metabolic health and turn back the clock, so to speak, on their metabolic age.”
The INSPIRE study completed enrollment at 16 patients, out of which 13 patients havereached the six-month follow-up, and 11 of 13 (85%) are insulin-free. The remaining three patients are still in the trial but have not reached their six-month follow-up for this interim analysis. In addition, patients have seen nearly 45 percent reduction in liver fat on MRI-PDFF (from a baseline of 8.5 percent absolute liver fat), along with significant improvements in blood pressure and weight.
Previous clinical studies of Revita DMR in more than 200 patients have demonstratedsustained improvements in blood glucose levels, insulin resistance measures, liver fat, cardiovascular risk markers, and weight loss, unaided by any lifestyle intervention, through one year of follow-up. In all clinical studies, Revita DMR was well-tolerated and demonstrated an acceptable safety profile.
“Type 2 diabetes is complicated with many severe co-morbidities, often managed withmultiple daily medications. But with Revita DMR, we continue to see positive clinical effects on diabetes, fatty liver, and cardiovascular disease, after treatment,” said Juan Carlos Lopez-Talavera, M.D., Ph.D., chief medical officer of Fractyl. “By targeting the root cause of metabolic disease, Revita DMR can provide significant and sustained disease modification for the patient, in addition to reducing their disease management burden.”
Non-alcoholic fatty liver disease (NAFLD/NASH) and T2D have both reached epidemic levels in the United States and around the world, and there are currently no FDA-approved treatments for NAFLD/NASH. Of particular concern, are the estimated 18 million Americans who have both conditions, and hence much higher risk of negative outcomes.1 Data presented at ILC 2019 showed that Revita DMR can generate significant improvements in people with both NAFLD/NASH and T2D conditions.
The first U.S. clinical trial for Revita DMR is currently taking place at five sites and is recruiting T2D patients on oral anti-diabetic medications with inadequately controlled diabetes. For a full list of inclusion and exclusion criteria, visit ClinicalTrials.gov.
1. Bazick et al. Diabetes Care, 2015.