Fractyl Health Presents Clinical Update on Revita® German Real-World Registry for Patients With Advanced Type 2 Diabetes (T2D)
13 Maio 2024 - 7:00AM
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
6-month follow-up data from its enrolling German real-world
registry study of Revita for T2D.
The first 14 consented registry participants have now completed
at least 6 months of post-Revita follow up. At baseline, prior to
Revita, these participants were a median age of 62 years, had a
median body weight of 111 kg and advanced T2D with an average of 14
years since diagnosis. Despite using up to three different glucose
lowering medications, participants’ T2D remained uncontrolled with
a median baseline HbA1c of 9.2%.
These 14 participants underwent Revita and experienced an
average total body weight loss of 8.1% at 6 months after the
procedure, with generally sustained or improved weight loss from
month 1 to month 6. These real-world findings further support the
potential of Revita for durable maintenance of weight loss. Fasting
blood glucose also improved after the procedure, falling from a
baseline median of 153 to 116 mg/dL at 6 months, and HbA1c improved
from a median of 9.2 to 7.6%, reflecting better glucose control,
despite all patients stabilizing or reducing the number of
glucose-lowering medications. No device or procedure-related
serious adverse events have been reported to date.
Professor Stephan Martin, Director of the West German Diabetes
Center of Excellence offering Revita combined with dietary and
lifestyle support in Düsseldorf, Germany recently presented the
Revita registry study 3-month follow-up results at the German
Diabetes Association (DDG) annual meeting, held in Berlin May
8-11th.
“Early results from our real-world registry suggest that
patients who undergo Revita can experience significant improvement
in blood sugar, reduction in body weight, and stabilization or
reduction of medication burden,” said Timothy Kieffer, Chief
Scientific Officer at Fractyl Health. “These results are
particularly impressive considering that most patients in the
registry have been struggling with advanced T2D and inadequate
control despite treatment with standard-of-care polypharmacy for
many years. In particular, the maintenance of body weight loss
through 6 months of follow up is a promising indicator for our
ongoing clinical development program in weight maintenance through
our Remain-1 pivotal study.”
To date, 26 of the 33 participants treated with Revita in
Germany have consented to participate in the Revita Registry.
Periodic updates on the Revita Registry and real-world clinical
outcomes for patients in Germany undergoing Revita treatment will
be shared as the study continues to expand and enroll.
About Fractyl Health
Fractyl Health is a metabolic therapeutics company focused on
pioneering new approaches to the treatment of metabolic diseases,
including obesity and T2D. Despite advances in treatment over the
last 50 years, obesity and T2D 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
https://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. A pivotal study of Revita in
patients with obesity after discontinuation of GLP-1 based drugs,
called Remain-1, is anticipated to initiate in H2 2024.
About Rejuva
Fractyl Health’s Rejuva® platform focuses on developing
next-generation adeno-associated virus (AAV)-based, locally
delivered gene therapies for the treatment of obesity and T2D. The
Rejuva platform is in preclinical development and has not yet been
evaluated by regulatory agencies for investigational or commercial
use. Rejuva leverages advanced delivery systems and proprietary
screening methods to identify and develop metabolically active gene
therapy candidates targeting the pancreas. The program aims to
transform the management of metabolic diseases by offering novel,
disease-modifying therapies that address the underlying root causes
of disease.
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, including, without limitation,
statements regarding the promise and potential impact of our
preclinical or clinical trial data, the design, initiation, timing,
expansion, progression and results of clinical enrollment and any
clinical trials or readouts, the potential benefits or launch or
commercialization of any of our product candidates or products, and
our strategic and product development objectives and goals,
including with respect to enabling long-term control over obesity
and type 2 diabetes without the burden of chronic therapies. 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
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 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 Company’s
product candidates or products and our strategic and product
development objectives and goals, and the other factors discussed
under the caption “Risk Factors” in our Quarterly Report on Form
10-Q filed with the Securities and Exchange Commission (the “SEC”)
on May 13, 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 ContactLisa Davidson, Chief
Financial Officerir@fractyl.com, 781.902.8800
Media ContactBeth Brett, Corporate
Communicationsbbrett@fractyl.com, 720.656.6544
Investor ContactStephen
JasperGilmartin Groupstephen@gilmartinir.com, 619.949.3681
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