Vivani’s GLP-1 (exenatide) implant produced
sham-implant adjusted liver fat reduction of 82% in an obese mouse
model from a single administration with expected twice-yearly
dosing
Vivani previously announced sham-implant
adjusted preclinical weight loss of 20%, which is comparable to the
weight loss produced from the semaglutide (active ingredient in
Ozempic®/Wegovy®) injection control arm in the same study
Clinical development of Vivani’s exenatide
implant in overweight and obese patients as part of the Company’s
NPM-115 program remains on track to commence in the fourth quarter
of 2024
Vivani Medical, Inc. (Nasdaq: VANI) (“Vivani” or the “Company”),
an innovative biopharmaceutical company developing miniature, ultra
long-acting, subdermal drug implants, today reported positive
preclinical liver fat results with its exenatide implant.
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Liver fat % area for exenatide implant vs
sham implant 12 weeks after a single administration. Liver fat %
area is calculated using Oil Red O (ORO) staining. Values are mean
± SE. (Graphic: Business Wire)
“The reduction in liver fat observed preclinically with our
miniature, subdermal exenatide implant, provides further support
that the NanoPortal™ implant technology continues to hold great
potential as a highly differentiated treatment option for the
treatment of obesity and chronic weight management as well as
related metabolic disorders,” said Adam Mendelsohn, Ph.D., Vivani
President and Chief Executive Officer. “While the currently
marketed GLP-1 based drugs have made profound improvements in the
treatment of chronic diseases, including obesity and chronic weight
management, significant barriers to optimal patient outcomes
persist due to medication non-adherence and poor tolerability. We
remain committed to the development of our portfolio of innovative,
miniature, GLP-1 implant candidates and their potential to improve
real-world patient outcomes by improving medication adherence. In
addition, we believe that our implant’s minimally fluctuating
release profile combined with avoiding inevitable drug fluctuations
that result from poor adherence may have the potential to improve
treatment tolerability, a primary complaint associated with
currently available GLP-1 treatment options. Our first clinical
study, LIBERATE-1™, is anticipated to start in the fourth quarter
of 2024 with results in 2025.”
Liver Fat Reduction in High Fat Diet-induced Obese
Mice
These liver fat data are consistent with published results from
similar investigations with semaglutide, the active pharmaceutical
ingredient in Ozempic and Wegovy.
Previously reported results from this study in high-fat
diet-induced obese mice demonstrated that Vivani’s exenatide
implant generated weight loss of approximately 20% compared to a
sham implant control after a 28-day treatment duration, comparable
to the weight loss observed in the semaglutide active control arm
in the study. The supratherapeutic doses provided for the exenatide
implant (single administration delivering exenatide at ~530
nmol/kg/day) and semaglutide (weekly injections of ~2,700
nmol/kg/week) were selected to maximize the weight-loss potential
of both exenatide and semaglutide.
Weight Loss in High Fat Diet-induced Obese Mice
NPM-115 Program
In July 2024, Vivani provided an update on the clinical
development plans for its obesity program, NPM-115, which will
evaluate the Company’s miniature, long-acting exenatide implant in
obese and overweight patients. In support of the recent strategic
shift to prioritize the development of its obesity and chronic
weight management portfolio, the Company announced revised plans to
evaluate its GLP-1 implant as part of the NPM-115 program in
individuals who are obese or overweight in the Company’s
first-in-human study, LIBERATE-1. This study will enroll
participants who will be titrated on weekly semaglutide (Wegovy)
for eight weeks before being randomized to receive a single
exenatide implant, weekly exenatide injections (Bydureon BCise®),
or weekly semaglutide injections for a nine-week treatment
duration. The Company expects the study to be initiated in the
fourth quarter of 2024 in Australia, pending regulatory approval,
with data from the study anticipated in 2025.
Ozempic® and Wegovy® are a registered trademarks of Novo Nordisk
A/S. Bydureon BCise® is a registered trademark of the AstraZeneca
group of companies.
About Vivani Medical, Inc.
Leveraging its proprietary NanoPortal™ platform, Vivani develops
biopharmaceutical implants designed to deliver drug molecules
steadily over extended periods of time with the goal of
guaranteeing adherence, and potentially to improve tolerance to
their medication. Vivani’s lead program, NPM-115, will evaluate a
miniature, six-month, subdermal, GLP-1 (exenatide) implant for
chronic weight management in obese or overweight individuals.
Vivani’s emerging pipeline also includes NPM-139 (semaglutide
implant) which is also under development for chronic weight
management in obese and overweight patients. NPM-139 has the added
potential benefit of once-yearly administration. NPM-119 refers to
the Company’s clinical program which will evaluate its six-month,
subdermal exenatide implant for the treatment of type 2 diabetes.
These NanoPortal implants are designed to provide individuals with
the opportunity to realize the full potential benefit of their
medication by avoiding the challenges associated with the daily or
weekly administration of orals and injectables. Medication
non-adherence affects an alarming number of patients, approximately
50%, including those taking daily pills. Medication non-adherence,
which contributes to more than $500 billion in annual avoidable
healthcare costs and 125,000 potentially preventable deaths
annually in the U.S. alone, is a primary and daunting reason why
obese or overweight individuals, and those taking treatments for
type 2 diabetes or other chronic diseases, face significant
challenges in achieving positive real-world effectiveness. While
the current GLP-1 landscape includes over 50 new molecular entities
under clinical stage development, Vivani remains confident that its
highly differentiated portfolio of miniature long-acting GLP-1
implants have the potential to provide an attractive therapeutic
option for patients, prescribers and payers.
Forward-Looking Statements
This press release contains certain “forward-looking statements”
within the meaning of the “safe harbor” provisions of the US
Private Securities Litigation Reform Act of 1995. Forward-looking
statements can be identified by words such as: “target,” “believe,”
“expect,” “will,” “may,” “anticipate,” “estimate,” “would,”
“positioned,” “future,” and other similar expressions that in this
press release, including statements regarding Vivani’s business,
products in development, including the therapeutic potential
thereof, the planned development therefor, the initiation of the
LIBERATE-1 trial and reporting of trial results, Vivani’s emerging
development plans for NPM-115, NPM-139, and NPM-119.
Forward-looking statements are neither historical facts nor
assurances of future performance. Instead, they are based only on
Vivani’s current beliefs, expectations, and assumptions. Because
forward-looking statements relate to the future, they are subject
to inherent uncertainties, risks and changes in circumstances that
are difficult to predict and many of which are outside of Vivani’s
control. Actual results and outcomes may differ materially from
those indicated in the forward-looking statements. Therefore, you
should not rely on any of these forward-looking statements.
Important factors that could cause actual results and outcomes to
differ materially from those indicated in the forward-looking
statements include, among others, risks related to the development
and commercialization of Vivani’s products, including NPM-115,
NPM-139, and NPM-119; delays and changes in the development of
Vivani’s products, including as a result of applicable laws,
regulations and guidelines, potential delays in submitting and
receiving regulatory clearance or approval to conduct Vivani’s
development activities, including Vivani’s ability to commence
clinical development of NPM-115; risks related to the initiation,
enrollment and conduct of Vivani’s planned clinical trials and the
results therefrom; Vivani’s history of losses and Vivani’s ability
to access additional capital or otherwise fund Vivani’s business.
There may be additional risks that the Company considers
immaterial, or which are unknown. A further list and description of
risks and uncertainties can be found in the Company’s most recent
Annual Report on Form 10-K filed with the U.S. Securities and
Exchange Commission filed on March 26, 2024, as updated by the
Company’s subsequent Quarterly Reports on Form 10-Q. Any
forward-looking statement made by Vivani in this press release is
based only on information currently available to the Company and
speaks only as of the date on which it is made. The Company
undertakes no obligation to publicly update any forward-looking
statement, whether written or oral, that may be made from time to
time, whether as a result of added information, future developments
or otherwise, except as required by law.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240904740218/en/
Company Contact: Donald Dwyer Chief Business
Officer info@vivani.com (415) 506-8462
Investor Relations Contact: Jami Taylor Investor
Relations Advisor investors@vivani.com (415) 506-8462
Media Contact: Sean Leous ICR Westwicke
sean.leous@westwicke.com (646) 866-4012
Vivani Medical (NASDAQ:VANI)
過去 株価チャート
から 10 2024 まで 11 2024
Vivani Medical (NASDAQ:VANI)
過去 株価チャート
から 11 2023 まで 11 2024
