Fractyl Health Presents Compelling Preclinical Data from Single-Administration GLP-1 Pancreatic Gene Therapy Rejuva® at Digestive Disease Week 2024
20 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), presented new data
from its preclinical Rejuva pancreatic gene therapy program as part
of an oral presentation (abstract number 4029196) on Sunday, May
19th, at Digestive Disease Week (DDW) 2024 in Washington, D.C.
“Metabolic dysfunction-associated steatotic liver disease
(MASLD) and metabolic dysfunction associated steatohepatitis (MASH)
are the leading cause for liver transplant in the U.S. today. These
diseases are caused by metabolic disease-associated accumulation of
liver triglycerides and consequent liver inflammation. GLP-1-based
drugs have demonstrated improved MASH in humans and are under
investigation as a potential therapy for MASH. This is the first
demonstration of a GLP-1-based pancreatic gene therapy (GLP-1 PGTx)
on liver metabolic health in an obesity murine model – one that has
strong potency, durable results, and a single administration,” said
Harith Rajagopalan, M.D., Ph.D., co-founder and Chief Executive
Officer of Fractyl. “These data potentially open the door to a
curative intervention for MASLD/MASH that is accessible to
gastroenterologists to perform. Fractyl plans to nominate its first
GLP-1 PGTx candidate for obesity in the second half of 2024 and is
eager to explore potential effects on MASLD/MASH.”
In the presentation titled “Single-Dose GLP-1-Based Pancreatic
Gene Therapy Maintains Weight Loss After Semaglutide Withdrawal and
Reduces Hepatic Triglycerides in a Murine Model of Obesity,” data
showed that Rejuva reduced liver weight by 42% (p<0.01) and
liver triglyceride content by 67% (p<0.0001) compared to placebo
two months after administration.
Data also showed a reduction of 36% in total cholesterol and 51%
in LDL cholesterol compared to placebo two months after
administration (both, p<0.0001). These results indicate the
potential impact of this GLP-1 PGTx candidate to alleviate
cardiovascular risk associated with increased levels of
cholesterol.
Rejuva is the Company’s modular, physiologic gene therapy
platform with three key elements designed to enable successful
pancreatic gene therapy: (1) a proprietary delivery catheter
designed to enable local, low-dose, therapeutic delivery directly
to the pancreas via endoscopic access, (2) vectors with tropism for
the pancreatic islet to enable successful transduction and gene
delivery with limited biodistribution, and (3) transgenes with
tissue-restricted promoters and metabolically active peptides that
can durably impact glucose and weight control.
About Fractyl HealthFractyl 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 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.
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), the American Society for Gastrointestinal Endoscopy (ASGE)
and the Society for Surgery of the Alimentary Tract (SSAT), DDW is
an in-person and online meeting from May 18-21, 2024. The meeting
showcases more than 5,600 abstracts and hundreds of lectures on the
latest advances in GI research, medicine and technology. More
information can be found at www.ddw.org.
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 and results of clinical enrollment and
any clinical trials or readouts, the content, information used for,
timing or results of any IND-enabling studies or IND applications,
the potential launch or commercialization of any of our product
candidates or products, the sufficiency of our cash, cash
equivalents, and investments to fund our operating activities for
any specific period of time, 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
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; additional time may be required to develop
and obtain regulatory approval or certification for the Company’s
Rejuva gene therapy candidates; the Company’s reliance on third
parties to conduct certain aspects of the Company’s preclinical
studies and clinical studies; the Company’s reliance on third
parties for the manufacture of the materials for its Rejuva gene
therapy platform for preclinical studies and its ongoing 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 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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