Fractyl’s Revita DMR Same-Day Therapeutic Procedure Could End Daily Insulin Injections for Type 2 Diabetes Patients

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 metabolic
disease, 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 the
duodenum, 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 have
reached 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 demonstrated
sustained 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 with
multiple 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.





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 highly prevalent metabolic diseases. The Revita DMR procedure harnesses breakthrough insights in the role of the duodenum in causing insulin resistance and metabolic diseases. 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 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.


Corporate Contact: Lisa Davidson, Chief Financial Officer, 17 Hartwell Avenue, Lexington, MA 02421, lisa@fractyl.com,+1.781.902.8800

Media Contact: Jessica Yingling, Ph.D., Little Dog Communications Inc., jessica@litldog.com,+1.858.344.8091