Vivani Medical Provides Update on Clinical Development Plans for Miniature, Long-term, GLP-1 Obesity Implant Program, NPM-115
11 July 2024 - 10:00PM
Business Wire
Vivani expects to initiate the first clinical
study supporting the NPM-115 program in the fourth quarter of
2024
The NPM-115 clinical program will consist of a
series of studies designed to support the development of Vivani’s
miniature, 6-month GLP-1 (exenatide) NanoPortal™ implant for
chronic weight management in obese or overweight patients
Vivani Medical, Inc. (Nasdaq: VANI) (“Vivani” or the “Company”),
an innovative, biopharmaceutical company developing novel,
long-term drug implants, today announced that it expects to
initiate the first clinical study in the NPM-115 program in the
fourth quarter of 2024 in Australia, pending regulatory clearance
in that country. The NPM-115 clinical program will evaluate the
investigational 6-month GLP-1 implant for chronic weight management
in patients who are either obese or overweight with a related
comorbidity.
“In February, our company announced that we were re-prioritizing
the development of our GLP-1 implants to focus on the treatment of
obesity and chronic weight management in response to the
significant medical need and unprecedented market demand,” said
Adam Mendelsohn, Ph.D., Vivani’s President and Chief Executive
Officer. “Today we can report that our first-in-human study,
LIBERATE-1, is expected to enroll patients who are obese or
overweight to primarily support NPM-115’s development program. We
anticipate initiating this clinical study in Australia later this
year.”
Dr. Mendelsohn continued: “The results of LIBERATE-1 may support
initiation of a subsequent clinical study, pending regulatory
clearance, to explore higher and potentially more effective doses
of our exenatide implant on weight and tolerability in obese or
overweight patients. Once the target dose is identified, we intend
to study an implant at that dose over the full 6-month duration,
over which our implant has already demonstrated encouraging results
in preclinical animal models. Additionally, we believe the results
of LIBERATE-1 may provide clinical validation of our NanoPortal
drug delivery technology to support a broader application of the
technology in the treatment of chronic diseases.”
LIBERATE-1 will be a randomized investigation of the safety,
tolerability and pharmacokinetic profile of the exenatide
NanoPortal implant in obese or overweight patients. The study will
enroll patients who will be titrated on weekly semaglutide
injections (Wegovy®) for 8 weeks (0.25 mg/week for 4 weeks followed
by 0.5 mg/week for 4 weeks) before being randomized to receive a
single administration of Vivani’s exenatide implant (n=8), weekly
exenatide injections Bydureon BCise® (n=8), or weekly 1 mg
semaglutide injections (n=8) for a 9-week treatment duration. The
exenatide implant to be used in LIBERATE-1 is expected to produce
comparable exenatide exposure levels as Bydureon BCise. Changes in
weight will be measured. The trial is expected to initiate later
this year with data projected to be available in 2025.
Background
On February 28, 2024, Vivani announced positive preclinical
weight loss data from its exenatide implant in support of its
NPM-115 development program which was comparable to semaglutide
injections (the active pharmaceutical ingredient in
Ozempic®/Wegovy®) and a strategic shift to prioritize its obesity
portfolio.
On June 13, 2024, Vivani announced that the U.S. Food and Drug
Administration (“FDA”) cleared its Investigational New Drug for its
exenatide implant to be studied in patients with type 2 diabetes in
support of the NPM-119 development program. The Company previously
announced an intention to initiate the first study in the NPM-119
program in the second half of this year. As a result of
reprioritizing the focus of its GLP-1 implants on the treatment of
obesity and chronic weight management, the Company plans to first
pursue the NPM-115 study. Dr. Mendelsohn noted that the NPM-115
program utilizes the same exenatide implant as NPM-119, and the
only difference is the population to be studied.
Vivani plans to submit an application to a Human Research Ethics
Committee in Australia to support the initiation of the Company’s
first-in-human study supporting the NPM-115 program in that
country. If available, Vivani intends to utilize research and
development incentives and rebates from the Australian government
in order to defray a portion of the costs from the trial. Since
clinical studies conducted in Australia comply with the
International Conference on Harmonization guidelines and data
generated in Australia are acceptable to the FDA and other
regulatory authorities, Vivani anticipates use of relevant clinical
data generated in Australia to support regulatory submissions in
other geographies including the US. Additional guidance will be
provided as new information becomes available.
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, the planned development therefor, the initiation of the
LIBERATE-1 trial and reporting of trial results, our emerging
development plans for NPM-115 and NPM-119 clinical programs.
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 those produced
from the NPM-115 and NPM-119 clinical programs; delays and changes
in the development of our products, 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, including our ability to obtain
regulatory clearance to conduct LIBERATE-1 in Australia, commence
clinical development; 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
U.S. Securities Exchange Commission filed on March 26, 2024, 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20240711383258/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 Senior Vice President ICR
Westwicke Sean.Leous@westwicke.com (646) 866-4012
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