UPDATE -- Fractyl Health Announces New Results From Its Rejuva® Platform Demonstrating Potent and Durable Effects of a Single Dose of a Human GLP-1 Pancreatic Gene Therapy Transgene Compared to Semaglutide in the db/db Mouse Model of Diabetes and Obesity
13 March 2024 - 5:06AM
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
promising new preclinical findings for the first clinical candidate
in its Rejuva® pancreatic gene therapy platform. RJVA-001 is the
Company’s first GLP-1 gene therapy candidate to emerge from the
platform, setting the stage for a potentially transformative
approach to treating metabolic diseases, including obesity and T2D.
“As we advance our Rejuva program
through preclinical development, we now observe that a single-dose
administration of a human GLP-1 transgene (as in RJVA-001) can
achieve durable lowering of blood sugar and body weight compared to
vehicle or chronic semaglutide administration in the well-validated
db/db mouse model of diabetes,” said Dr. Timothy Kieffer, Fractyl
Health Chief Scientific Officer. “With these data, we are one step
closer to IND enablement for RJVA-001 as part of our broader
preclinical development package.”
These results show that the human
GLP-1 coding sequence of RJVA-001 demonstrates potency on both
glucose lowering and weight loss in db/db mice, the standard rodent
T2D efficacy model used for clinical development. The Company has
reached alignment with European regulators on the use of this
efficacy model to support the submission of a Clinical Trial
Application (CTA) in Europe.
“While there are clear benefits of
GLP-1 for weight loss, glucose control, and metabolic health in
general, there remains a need for advances in care that can offer a
major step forward in GLP-1 therapy,” said Dr. Harith Rajagopalan,
CEO of Fractyl Health. “Our goal with RJVA-001 is to change the
trajectory of both obesity and T2D with a single administration
therapy that offers the potential for the durable remission of
metabolic disease.”
Fractyl Health anticipates progressing
RJVA-001 through IND-enabling toxicity studies in 2024 and
initiating First-in-Human clinical studies in the first half of
2025.
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 Rejuva Fractyl
Health’s Rejuva® platform focuses on developing
next-generation adeno-associated virus (AAV)-based, locally
delivered gene therapies for the treatment of T2D and obesity. 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. 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; changes in methods of the Company’s Rejuva gene therapy
candidate manufacturing or formulation; and any contamination or
interruption in the Company’s Rejuva gene therapy candidates’
manufacturing process, shortages of raw materials or failure of the
Company’s suppliers of plasmids and viruses to deliver necessary
components could result in delays in the Company’s Rejuva gene
therapy candidates’ preclinical and clinical development or
marketing schedules. These and other important factors discussed
under the caption "Risk Factors" in the Company’s prospectus filed
with the Securities and Exchange Commission (the “SEC”) on February
2, 2024, and its other filings with the SEC, could cause actual
results to differ materially from those indicated by the
forward-looking statements made in this press release. Any such
forward-looking statements represent management's estimates as of
the date of this press release. 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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