NPM-115 (exenatide implant) generated
significant weight loss comparable to injectable semaglutide
(Ozempic®/Wegovy®) from a single administration with expected
twice-yearly dosing
Vivani discloses semaglutide as the active
pharmaceutical ingredient in NPM-139, with the added potential
benefit of once-yearly dosing
NPM-115 and NPM-139 are miniature, subdermal
implants in development for chronic weight management designed to
guarantee medication adherence and potentially improve treatment
tolerability by providing smooth and steady delivery of GLP-1
therapy
Vivani Medical, Inc. (Nasdaq: VANI) (“Vivani” or the “Company”),
an innovative, preclinical-stage biopharmaceutical company
developing novel, long-term drug implants, today announced positive
preclinical data on weight loss effects for NPM-115, the Company’s
miniature, twice-yearly, exenatide implant under development for
the treatment of chronic weight management. The Company also
disclosed that semaglutide is the active pharmaceutical ingredient
in NPM-139, a miniature, subdermal GLP-1 implant in development for
chronic weight management, with the added potential benefit of
once-yearly administration. These developments are part of a
strategic shift to prioritize the Company’s obesity implants based
on emerging data regarding the potential for high-dose GLP-1
products to improve health outcomes for obese and overweight
patients.
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the full release here:
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Weight difference from control in healthy
Sprague-Dawley Rats. % weight change from baseline for NPM-119
(exenatide) corrected to control (vehicle implant). Values are mean
± SE. (Photo: Business Wire)
“In response to tremendous medical need and unprecedented market
demand, we are prioritizing the development of our GLP-1 implants
for the treatment of obesity and chronic weight management. Since a
high-dose GLP-1 implant for obesity would likely also be able to
address our previous type 2 diabetes focus, the recently generated
compelling weight loss data from NPM-115 naturally supports a shift
in focus towards an indication with even broader potential. We
believe the primary expected advantages of our proprietary
NanoPortal™ implant technology, improving medication adherence and
medication tolerability, have the potential to transform and
advance the adoption of GLP-1 therapy in the future.” said Adam
Mendelsohn, Ph.D., Vivani President and Chief Executive Officer.
“The potential for long-term GLP-1 implants becomes even more
compelling when you consider that the improved adherence and
persistence of Ozempic and Wegovy over prior obesity medications is
still only 40% as recently reported in a large retrospective cohort
study published in the research journal Obesity. Collectively, the
potential for improvement in medication adherence, tolerability and
real-world patient outcomes motivates us to rapidly advance the
development of NPM-115, NPM-139 and the balance of our
portfolio.”
In a study in high-fat diet-induced obese mice, NPM-115
generated weight loss of approximately 20% compared to a sham
implant control after a 28-day treatment duration, comparable to
weight loss observed in mice treated with semaglutide injections
(Ozempic/Wegovy) in the same study. The supratherapeutic doses
provided for both NPM-115 (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.
In a second study in healthy rats, a single administration of
the Company’s exenatide implant NPM-119, in development for the
treatment of type 2 diabetes, resulted in body weights that were
approximately 25% lower than a vehicle implant control after 15
weeks of treatment with an expected duration of effect of six
months. NPM-119 delivered exenatide at a rate of approximately 320
nmol/kg/day and has demonstrated smooth, non-fluctuating release of
exenatide in both in vitro and in vivo studies. NPM-119 has
previously demonstrated pharmacokinetic data exhibiting continuous
and therapeutic exenatide exposure levels over a six-month duration
in healthy rats. Since NPM-115 is a higher-dose version of an
otherwise similar product as NPM-119, the durability of the effect
on weight demonstrated in this study is expected to translate to
future studies utilizing NPM-115.
These preclinical data provide further evidence that the weight
loss potential of exenatide treatment in humans may be comparable
to other GLP-1 molecules such as semaglutide assuming adequate
exposure levels are achieved and maintained. The weight loss
potential of exenatide in humans has not been fully evaluated in
the currently marketed exenatide products Byetta® (twice-daily
injection) and Bydureon® (weekly injection) potentially due to
limitations associated with adherence and dosing. NPM-115 directly
addresses these limitations. It is designed to improve adherence by
enabling patients to receive continuous dosing over a six-month
interval from a single administration. NPM-115 is planned to
maximize exenatide’s weight loss effect in humans, pending further
development and regulatory clearance, by evaluating exenatide
exposure levels higher than previously explored.
Dr. Mendelsohn will present study results on May 17 at the TIDES
USA 2024 conference in Boston.
About Vivani Medical, Inc.
Leveraging its proprietary NanoPortal™ platform, Vivani Medical
develops biopharmaceutical implants designed to deliver drug
molecules steadily over extended periods of time with the goal of
guaranteeing adherence, and potentially to improve medication
tolerability. Vivani’s NPM-115 and NPM-119 are miniature,
six-month, GLP-1 implants in development for the treatment of
chronic weight management in obese or overweight patients and type
2 diabetes, respectively. Both NPM-115 and NPM-119 are exenatide
based products with a higher-dose associated with NPM-115 for the
treatment of chronic weight management in obese or overweight
patients. An IND for NPM-119’s first-in-human study LIBERATE-1 has
been submitted and is on clinical hold pending requests by the FDA
for additional chemistry, manufacturing, and controls (CMC)
information. Vivani anticipates submitting the requested CMC
information to the FDA in the first half of 2024. LIBERATE-1 is a
randomized, 12-week investigation of the safety, tolerability, and
full pharmacokinetic profile of NPM-119 in patients with type 2
diabetes. Vivani is also preparing to submit an IND for a
first-in-human study with NPM-115 for the treatment of chronic
weight management later this year. These NanoPortalTM implants are
designed to provide patients 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 occurs when
patients do not take their medication as prescribed. This 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 patients,
and patients taking type 2 diabetes or other chronic disease
medications face significant challenges in achieving positive
real-world effectiveness.
Vivani’s wholly owned subsidiary Cortigent is developing
targeted neurostimulation systems intended to help patients recover
critical body functions. Investigational devices include Orion®,
designed to provide artificial vision to people who are profoundly
blind, and a new system intended to accelerate the recovery of arm
and hand function in patients who are partially paralyzed due to
stroke. Vivani continues to assess strategic options for advancing
Cortigent’s pioneering technology.
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 our business,
products in development, including the therapeutic potential
thereof, plans to address any requests from the FDA related to the
agency’s current clinical hold on NPM-119, the initiation of the
LIBERATE-1 trial and reporting of trial results, the planned
development therefor, our emerging development plans for NPM-115,
NPM-139, or our plans with respect to Cortigent and its proposed
initial public offering, technology, strategy, cash position and
financial runway. Forward-looking statements are neither historical
facts nor assurances of future performance. Instead, they are based
only on our 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 our
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 our products, including NPM-115 and
NPM-119; delays and changes in the development of our products,
including our ability to address any requests from the FDA related
to LIBERATE-1 and to commence clinical development of NPM-119,
including as a result of applicable laws, regulations and
guidelines, potential delays in submitting and receiving regulatory
clearance or approval to conduct our development activities, risks
related to the initiation, enrollment and conduct of our planned
clinical trials and the results therefrom; our history of losses
and our ability to access additional capital or otherwise fund our
business; market conditions and the ability of Cortigent to
complete its initial public offering. 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 SEC filed on March 31, 2023, as updated by our subsequent
Quarterly Reports on Form 10-Q. Any forward-looking statement made
by us 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/20240228342864/en/
Company Contact: Donald Dwyer Chief Business Officer
info@vivani.com (415) 506-8462 Investor Relations Contact: Brigid
A. Makes Chief Financial Officer investors@vivani.com (415)
506-8462 Media Contact: Sean Leous ICR Westwicke
Sean.Leous@westwicke.com (646) 866-4012
Vivani Medical (NASDAQ:VANI)
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