Fractyl Health Receives FDA IDE Approval for the Revita® Remain-1 Pivotal Study of Weight Maintenance in Obesity after Discontinuation of GLP-1 Based Drugs
01 April 2024 - 9:00PM
Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a metabolic
therapeutics company focused on pioneering new approaches for the
treatment of obesity and type 2 diabetes (T2D), today announced
U.S. Food and Drug Administration (FDA) approval of a pivotal
Investigational Device Exemption (IDE) to study Revita’s efficacy
in maintaining weight loss following the discontinuation of GLP-1
receptor agonist (GLP-1RA) drug therapy, addressing a key unmet
need in the treatment of obesity. Obesity affects over 40% of the
US population and is a critical precursor to various highly morbid
and expensive chronic conditions such as type 2 diabetes, metabolic
dysfunction-associated fatty liver disease, and cardiovascular
disease.
The IDE approval launches the
groundbreaking Remain-1 study, set to begin in the second half of
2024. Remain-1 is a randomized, double-blind trial of Revita versus
sham in patients who have lost at least 15% total body weight on
tirzepatide therapy. It is designed to be a pivotal study to
potentially enable registrational filing for Revita for weight
maintenance after GLP-1RA discontinuation. In parallel with the
randomized portion of the Remain-1 study, Fractyl Health also
announces Reveal-1, an open-label cohort that will follow a similar
patient population and management protocol with anticipated
open-label data updates as the study progresses.
The rationale for the Remain-1 pivotal
study is based on a new need for therapeutic solutions that can
offer durable weight maintenance without ongoing medical therapy.
Highly potent drugs in the GLP-1RA class, including semaglutide
(Wegovy®) and tirzepatide (Zepbound®), are now approved for the
management of obesity and have dramatically altered the treatment
landscape. However, real world studies report high discontinuation
rates and clinical trials have indicated the risk of substantial
weight rebound after discontinuation in many participants.
Strategies to maintain weight loss independent of ongoing medical
therapy could provide substantial clinical and economic benefits by
extending the value of GLP-1RA drugs even after these medicines are
discontinued.
“The unmet need in obesity is shifting
from ‘How do we help people lose weight?’ to ‘How do we help people
keep the weight off?’” said Christopher Thompson, MD MSc, Director
of Endoscopy at Brigham and Women’s Hospital, Co-Director, Center
for Weight Management and Wellness at Brigham Health, and Professor
of Medicine at Harvard Medical School. “We now need new therapeutic
strategies that can offer durable weight maintenance, and I am
excited for the prospect of the Remain-1 pivotal study to hopefully
address this massive challenge in obesity today.”
Revita is an outpatient endoscopic
procedure that targets the duodenum and is designed to reverse
pathology in the duodenal lining that is a root cause of obesity
and T2D. In prior clinical studies of Revita conducted in people
with T2D in the US and EU, pooled analyses of weight data provided
evidence to support the potential for durable weight maintenance
after a single Revita procedure.
The patient population for Remain-1
will consist of obese individuals with a BMI ≥ 30 kg/m^2. These
GLP-1RA-naïve individuals will initiate tirzepatide therapy,
titrated to achieve at least a 15% total body weight loss, followed
by discontinuation of tirzepatide and randomization to either
Revita treatment or a sham procedure. At least 315 subjects will be
randomized 2:1 to Revita or sham.
The primary objectives of the study
are
- to demonstrate that Revita is superior to sham in percent
change in body weight from baseline to week 24, and
- to demonstrate that a majority of Revita participants maintain
clinically significant weight loss after discontinuing tirzepatide
therapy.
"We believe there is substantial
clinical and economic value in new approaches to obesity that can
enable durable weight maintenance after stopping GLP-1 based
drugs," said Dr. Harith Rajagopalan, CEO of Fractyl Health. "We
were very happy to work collaboratively with key advisors in
obesity and gastrointestinal endoscopy by rapidly developing this
protocol to address a huge, emergent unmet need in the field."
About Fractyl Health
Fractyl Health is a metabolic therapeutics company focused on
pioneering new approaches to the treatment of metabolic diseases,
including T2D and obesity. Despite advances in treatment over the
last 50 years, T2D and obesity continue to be rapidly growing
drivers of morbidity and mortality in the 21st century. Fractyl
Health’s goal is to transform metabolic disease treatment from
chronic symptomatic management to durable disease-modifying
therapies that target the organ-level root causes of disease.
Fractyl Health is based in Burlington, MA. For more information,
visit www.fractyl.com or www.twitter.com/FractylHealth.
About Revita Fractyl
Health’s lead product candidate, Revita, is based on the company’s
insights surrounding the potential role of the gut in obesity and
T2D. 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 disease. Revita has
received a CE mark in Europe and, in January 2022, received
reimbursement authorization through NUB in Germany for the
treatment of T2D. In the United States, Revita is for
investigational use only under US law. A pivotal study of Revita in
patients with inadequately controlled T2D despite multiple
medicines and insulin, called Revitalize-1, is currently enrolling
in the United States and Europe.
Forward-Looking
Statements This press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. All statements contained in this press release
that do not relate to matters of historical fact should be
considered forward-looking statements. These statements are neither
promises nor guarantees, but involve known and unknown risks,
uncertainties and other important factors that may cause the
Company’s actual results, performance or achievements to be
materially different from any future results, performance or
achievements expressed or implied by the forward-looking
statements, including, but not limited to, the following: the
Company’s limited operating history; the incurrence of significant
net losses and the fact that the Company expects to continue to
incur significant net losses for the foreseeable future; the
Company’s need for substantial additional financing; the Company’s
ability to continue as a going concern; the restrictive and
financial covenants in the Company’s credit agreement; the lengthy
and unpredictable regulatory approval process for the Company’s
product candidates; uncertainty regarding its clinical studies; the
fact that the Company’s product candidates may cause serious
adverse events or undesirable side effects or have other properties
that may cause it to suspend or discontinue clinical studies, delay
or prevent regulatory development, prevent their regulatory
approval, limit the commercial profile, or result in significant
negative consequences; the Company’s reliance on third parties to
conduct certain aspects of the Company’s preclinical studies and
clinical studies; the regulatory approval process of the FDA,
comparable foreign regulatory authorities and notified bodies, are
lengthy, time-consuming and inherently unpredictable, and even if
we complete the necessary clinical studies, we cannot predict when,
or if, we will obtain regulatory approval or certification for any
of our product candidates, and any such regulatory approval or
certification may be for a more narrow indication than we seek; and
the potential launch or commercialization of any of product
candidates or products and our strategic and product development
objectives and goals. These statements are neither promises nor
guarantees, but involve known and unknown risks, uncertainties and
other important factors that may cause our actual results,
performance or achievements to be materially different from any
future results, performance or achievements expressed or implied by
the forward-looking statements, including the factors discussed
under the caption “Risk Factors” in our Annual Report on Form 10-K
filed with the Securities and Exchange Commission (the “SEC”) on
April 1, 2024, and in our other filings with the SEC. These
forward-looking statements are based on management's current
estimates and expectations. While the Company may elect to update
such forward-looking statements at some point in the future, the
Company disclaims any obligation to do so, even if subsequent
events cause its views to change.
Contacts Corporate
Contact Lisa Davidson, Chief Financial Officer
ir@fractyl.com, 781.902.8800
Media Contact Beth Brett, Corporate
Communications Bbrett@fractyl.com,
720.656.6544
Investor Contact Stephen Jasper
Gilmartin Group stephen@gilmartinir.com,
619.949.3681
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