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.–(BUSINESS WIRE)–#ADA2019–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.

Contacts

Corporate Contact: Lisa Davidson, Chief Financial Officer,
Fractyl Laboratories Inc., [email protected],
+1.781.902.8800

Media Contact: Jessica Yingling, Ph.D., Little
Dog Communications Inc., [email protected],
+1.858.344.8091