LEXINGTON, Mass. and
ORLANDO, Fla., June 23, 2018 /PRNewswire/ -- Fractyl
Laboratories Inc. (Fractyl) today announced the presentation
of breakthrough research providing the first clear mechanistic link
between modern diets and their causal effect on the pandemics of
insulin resistance, obesity, and metabolic diseases. In an animal
model, a modern diet high in fat and sugar caused overgrowth of the
duodenal mucosa and overexpression of key gut hormones from the
duodenum, the first segment of the intestine. These findings
suggest a role of the duodenum in insulin resistance and metabolic
diseases. The results also provide a rational explanation for the
remarkable, weight-independent metabolic benefits of bariatric
surgeries that bypass the duodenum. Fractyl will be presenting data
supporting these findings with a poster (1900-P) entitled,
"Westernized Diet-Induced Insulin Resistance in Mice Is Associated
with Focal Duodenal Hyperplasia," on Monday,
June 25, from 12pm to 1pm EDT
at the American Diabetes Association's 78th Scientific Sessions
(ADA 2018) in Orlando, Fla.
Fractyl's lead product, Revita™ DMR, builds on
these scientific observations and aims to reverse duodenal
overgrowth with a minimally invasive intestinal procedural therapy
targeting this root cause of metabolic diseases, such as type 2
diabetes and nonalcoholic fatty liver disease (NAFLD), which can
progress to nonalcoholic steatohepatitis (NASH). At ADA, Fractyl's collaborator will
present full one-year clinical results from its single-arm,
multicenter Revita-1 clinical trial, including device safety and
durable effectiveness in this study of patients with poorly
controlled type 2 diabetes. The study demonstrated significant and
sustained reductions in HbA1c, insulin resistance, weight, and
cardiovascular risk markers more than one year after a single
procedure. Of particular interest, patients who also had evidence
of NAFLD experienced statistically significant reductions of ALT
from a baseline of 63 U/L to 41 U/L by six months and maintained at
41 U/L through one-year follow up, indicative of sustained benefit
in their metabolic liver disease. The poster (1137-P) will be
presented from 12pm to 1pm EDT on
Sunday, June 24.
"I am impressed with the response of a single DMR treatment on
metabolic health, including significantly lowering HbA1c levels by
more than one percentage point one year after a single outpatient
procedure, along with improvements in hepatic markers and weight
loss," said Ralph Defronzo, M.D.,
Professor of Medicine and Chief of Diabetes Division at the
University of Texas Health Science
Center and Deputy Director of the Texas Diabetes Institute,
San Antonio, Texas. "This is
consistent with our growing understanding of the key intestinal
mechanism driving metabolic disease, which is not addressed easily
with today's therapies. The potential of being able to do so with a
single procedure is promising and may offer a scientifically sound
and convenient treatment alternative for type 2 diabetes and fatty
liver disease."
Building on the scientific and clinical evidence presented at
ADA, Fractyl further announced that it has received an
investigational device exemption (IDE) from the U.S. Food and Drug
Administration (FDA) to initiate its first U.S. clinical trial of
Revita DMR. In the European Union, the Revita DMR System previously
received a CE mark and is currently being evaluated in a
sham-controlled clinical trial conducted in multiple European and
South American centers.
"Revita DMR is a minimally invasive procedure that builds on
bariatric science and best practices in gastrointestinal endoscopy
to offer a potential solution for many patients with type 2
diabetes and fatty liver disease," said Steven A. Edmundowicz, M.D., Medical Director,
Digestive Health Center, University of
Colorado Hospital. "Given the substantial number of patients
in our practices with these diseases and their tremendous unmet
medical need, we are eagerly seeking safe and effective therapeutic
options to help us restore the health of our patients."
"Our clinical data to date indicate that Revita DMR offers the
potential for unparalleled real world benefit for payers,
physicians, and patients at high risk from the complications of
metabolic diseases," said Harith
Rajagopalan, M.D., Ph.D., Cofounder and CEO of Fractyl. "We
at Fractyl are motivated by the enthusiasm and support we have
received by the clinical community worldwide, who see this as a
potentially transformative approach to addressing the global
epidemic of type 2 diabetes and fatty liver disease."
About Fractyl and Revita™ DMR
Fractyl Laboratories is a private therapeutics company
translating breakthrough insights in gut biology to develop
disease-modifying interventions designed to restore health.
Fractyl's Revita DMR is a same-day minimally invasive therapeutic
procedure that aims to treat two highly prevalent metabolic
diseases, type 2 diabetes and NAFLD/NASH, and provide an important alternative to
escalating T2D drug treatments. Currently, no therapies are
approved to treat NAFLD/NASH.
Revita DMR System received a CE mark for the treatment of Type 2
Diabetes in the European Union and an IDE exemption in the United States. The company plans to
initiate its US clinical investigation of the Revita DMR System by
the end of 2018. The Revita DMR System may be available for
investigational use in other regions. Fractyl is headquartered in
Lexington, Mass. For more
information, visit www.fractyl.com, www.twitter.com/FractylLabs,
or www.RevitaTrial.com.
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SOURCE Fractyl Laboratories Inc.