Fractyl Health Presents New Mechanistic Data on Revita® DMR in Type 2 Diabetes
22 Mai 2022 - 9:01AM
Business Wire
- Patients treated with Revita experienced a 0.8%-point reduction
in HbA1c along with a 33% improvement in markers of insulin
sensitivity three months after undergoing the procedure
- Markers of insulin production capacity in the pancreas also
improved, with a 25% increase in insulin secretion rate and a 37%
improvement in Disposition Index
Fractyl Health, an organ-editing metabolic therapeutics company
focused on pioneering a new approach to the treatment of type 2
diabetes (T2D), announced today new data from its Revita-1 and
Revita-2 studies. Prior publications from these open-label and
sham-controlled studies have shown improvements in glycemic control
and weight in subjects with inadequately controlled type 2
diabetes. New data presented at this week’s Digestive Disease Week®
(DDW) 2022 build on this earlier evidence to assess the effect of
Revita on insulin resistance, insulin production capacity, and key
metabolic hormones via a mixed meal tolerance test.
In the current investigation presented at DDW 2022, a pooled,
post-hoc mechanistic analysis of insulin sensitivity, beta cell
function, and metabolic hormone assessment was performed in all
patients who were treated in the Revita-1 and Revita-2 open-label
training phase studies in whom mixed meal tolerance tests were
performed at baseline and three months post-intervention. Results
in these subjects (n=28) exhibited the following findings at three
months after a single outpatient procedure:
- Glycemic control: 0.8%-point reduction in HbA1c (from
baseline of 8.2%; p=0.002) and 36 mg/dL reduction in fasting plasma
glucose (from baseline 198 mg/dL; p<0.001)
- Weight loss: 4.3 kg reduction in weight (4.7% total body
weight loss; p<0.001)
- Insulin resistance: 33% improvement in HOMA-IR and 32%
improvement in the Matsuda Index, two measures of insulin
resistance that have been associated with a heightened risk of T2D
progression (p=0.005 for each)
- Beta cell function: 25% improvement in insulin secretion
rate and 37% improvement in Disposition Index, two measures of
pancreatic beta cell function that reflect an improvement in the
pancreas’ ability to produce and secrete insulin in response to a
meal (p=0.002 and p=0.001, respectively)
- Gut hormones: The response of two key gut hormones known
to regulate blood sugar (GIP and GLP-1) in response to a meal was
unchanged after treatment with Revita
“The current data suggest that Revita may be the first
investigational therapy to offer the potential for improvements in
insulin sensitivity and pancreatic beta cell function months after
a single minimally invasive, outpatient intervention,” said Juan
Carlos Lopez-Talavera, M.D. Ph.D., Chief Medical Officer, Fractyl
Health. “These results raise intriguing questions about the
potential for therapeutic interventions targeting the duodenum to
help address underlying root causes of metabolic dysfunction in
people with T2D.”
About Revita®
Fractyl Health’s lead product candidate, Revita, is based on the
company’s insights surrounding the potential role of the gut in
metabolic diseases. Revita is designed to remodel the duodenal
lining via hydrothermal ablation (i.e., duodenal mucosal
resurfacing) to edit abnormal intestinal nutrient sensing and
signaling mechanisms that are a potential root cause of metabolic
diseases. In April 2016, Revita received a CE mark from the
European Union. In the United States, Revita is for investigational
use only and has received Breakthrough Device designation from the
FDA to improve glycemic control and eliminate insulin needs in T2D
patients who are inadequately controlled on long-acting
insulin.
About the Revitalize T2D Clinical Development Program
The Revitalize T2D program is a series of ongoing and planned
clinical studies sponsored by Fractyl Health to investigate the
potential utility of Revita in patients with, or at high risk for,
T2D. The company’s ongoing pivotal clinical study, Revitalize-1, is
designed as a randomized, double-blind crossover, sham-controlled,
multi-center study in patients with inadequately controlled T2D
despite being on metformin, up to two additional ADAs, and
long-acting insulin. The Revitalize-2 study is an ongoing pivotal
study in patients with T2D who are inadequately controlled on two
or three ADAs for whom insulin would be the next step in therapy.
The Revitalize-3 proof-of-concept pilot study is a planned study in
patients with high-risk prediabetes to evaluate the effects of
hydrothermal ablation of the duodenal mucosa using Revita to reduce
the risk of developing T2D.
About Fractyl Health
Fractyl Health is focused on pioneering a new approach to the
treatment of T2D. Despite advances in treatment over the last 50
years, metabolic diseases in general, and T2D in particular,
continue to be a principal and rapidly growing driver of morbidity
and mortality in the 21st century. Fractyl Health’s goal is to
transform T2D treatment from chronic blood glucose management to
disease-modifying therapies that target the organ-level root causes
of the disease. Fractyl Health’s lead product candidate, Revita, is
designed to remodel the duodenal lining via hydrothermal ablation
(i.e., duodenal mucosal resurfacing) in order to edit abnormal
intestinal nutrient sensing and signaling mechanisms that are a
potential root cause of metabolic diseases. Fractyl Health is a
private organ-editing metabolic therapeutics company based in
Lexington, MA. For more information, visit www.fractyl.com or
www.twitter.com/FractylHealth
About Digestive Disease Week®
Digestive Disease Week® (DDW) is the largest international
gathering of physicians, researchers and academics in the fields of
gastroenterology, hepatology, endoscopy and gastrointestinal
surgery. Jointly sponsored by the American Association for the
Study of Liver Diseases (AASLD), the American Gastroenterological
Association (AGA) Institute, the American Society for
Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of
the Alimentary Tract (SSAT), DDW is an in-person and virtual
meeting from May 21-24, 2022. The meeting showcases more than 3,100
abstracts and hundreds of lectures on the latest advances in GI
research, medicine and technology. More information can be found at
www.ddw.org.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220522005046/en/
Corporate Contact: Lisa Davidson, Chief Financial Officer
Lisa@fractyl.com, 781.902.8800
Media Contact: Lisa Raffensperger, Ten Bridge
Communications lisa@tenbridgecommunications.com, 617.903.8783