Outlook Therapeutics® Doses First Subject in NORSE EIGHT
31 Januar 2024 - 2:05PM
Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical
company working to achieve FDA approval for the first ophthalmic
formulation of bevacizumab for the treatment of retinal diseases,
today announced that the first subject has been dosed in the NORSE
EIGHT clinical trial evaluating ONS-5010 in neovascular age-related
macular degeneration (wet AMD) patients.
The NORSE EIGHT study is a randomized,
controlled, parallel-group, masked, non-inferiority study of
approximately 400 treatment naive, wet AMD subjects randomized in a
1:1 ratio to receive 1.25 mg ONS-5010 or 0.5 mg ranibizumab
intravitreal injections. Subjects will receive injections at Day 0
(randomization), Week 4, and Week 8 visits. The primary endpoint
will be mean change in Best Corrected Visual Acuity (BCVA) from
baseline to Week 8. Outlook Therapeutics expects NORSE EIGHT
topline results and resubmission of the ONS-5010 BLA by the end of
calendar year 2024.
“We are pleased with the continued progress of
our ONS-5010 development pathway forward. The start of patient
enrollment in NORSE EIGHT represents an important step toward
potential FDA approval and launch of ONS-5010. Our team remains
focused on the successful execution of the study,” commented
Russell Trenary, President and Chief Executive Officer.
Earlier this month, Outlook Therapeutics
announced that it received written agreement from the FDA under an
SPA for NORSE EIGHT. The FDA has reviewed and agreed upon the NORSE
EIGHT trial protocol pursuant to the SPA. If the NORSE EIGHT trial
is successful, it would satisfy the FDA’s requirement for a second
adequate and well-controlled clinical trial to address fully the
clinical deficiency identified in the Complete Response Letter
(CRL). In addition, through a Type A meeting and additional
interactions, Outlook Therapeutics has identified the approaches
needed to resolve the Chemistry, Manufacturing and Controls (CMC)
comments in the CRL. Outlook Therapeutics is working to
address the open CMC items in the CRL and expects to resolve these
comments prior to the expected completion of NORSE EIGHT.
For more information about the NORSE EIGHT
study, visit clinicaltrials.gov and reference identifier
NCT06190093.
About ONS-5010 / LYTENAVA™
(bevacizumab-vikg)
ONS-5010 is an investigational ophthalmic
formulation of bevacizumab under development as an intravitreal
injection for the treatment of wet AMD and other retinal diseases.
Because no FDA-approved ophthalmic formulations of bevacizumab are
available currently, clinicians wishing to treat retinal patients
with bevacizumab have had to use unapproved repackaged IV
bevacizumab provided by compounding pharmacies—products that have
known risks of contamination and inconsistent potency and
availability. If approved, ONS-5010 would provide an FDA-approved
option for physicians that currently prescribe unapproved
repackaged oncologic IV bevacizumab from compounding pharmacies for
the treatment of wet AMD.
Bevacizumab-vikg is a recombinant humanized
monoclonal antibody (mAb) that selectively binds with high affinity
to all isoforms of human vascular endothelial growth factor (VEGF)
and neutralizes VEGF’s biologic activity through a steric blocking
of the binding of VEGF to its receptors Flt-1 (VEGFR-1) and KDR
(VEGFR-2) on the surface of endothelial cells. Following
intravitreal injection, the binding of bevacizumab-vikg to VEGF
prevents the interaction of VEGF with its receptors on the surface
of endothelial cells, reducing endothelial cell proliferation,
vascular leakage, and new blood vessel formation in the retina.
About Outlook Therapeutics,
Inc.
Outlook Therapeutics is a biopharmaceutical
company working to achieve FDA approval for the launch of ONS-5010/
LYTENAVA™ (bevacizumab-vikg) as the first FDA-approved ophthalmic
formulation of bevacizumab for use in retinal indications,
including wet AMD, DME and BRVO. If ONS-5010 ophthalmic bevacizumab
is approved, Outlook Therapeutics expects to commercialize it as
the first and only FDA-approved ophthalmic formulation of
bevacizumab for use in treating retinal diseases in the United
States, United Kingdom, Europe, Japan, and other markets. As part
of Outlook Therapeutics' multi-year commercial planning process,
Outlook Therapeutics and Cencora entered into a strategic
commercialization agreement to expand Outlook Therapeutics’ reach
for connecting to retina specialists and their patients. Cencora
will provide third-party logistics (3PL) services and distribution,
as well as pharmacovigilance services and other services in the
United States. For more information, please visit
www.outlooktherapeutics.com.
Forward-Looking Statements
This press release contains forward-looking
statements. All statements other than statements of historical
facts are “forward-looking statements,” including those relating to
future events. In some cases, you can identify forward-looking
statements by terminology such as “continue,” “expect,” “plan,”
“potential,” “will,” or “would” the negative of terms like these or
other comparable terminology, and other words or terms of similar
meaning. These include, among others, statements about ONS-5010’s
potential as the first FDA-approved ophthalmic formulation of
bevacizumab-vikg, expectations concerning Outlook Therapeutics’
ability to remediate or otherwise resolve deficiencies identified
in the CRL issued by the FDA, including with respect to an
additional clinical trial and CMC issues, expectations concerning
the NORSE EIGHT trial design, the timing for completion of NORSE
EIGHT and resubmission of the BLA for ONS-5010, expectations
concerning decisions of the FDA, and the timing thereof, plans for
potential commercial launch of ONS-5010, expectations concerning
the relationship with Cencora and the benefits and potential
expansion thereof, and other statements that are not historical
fact. Although Outlook Therapeutics believes that it has a
reasonable basis for the forward-looking statements contained
herein, they are based on current expectations about future events
affecting Outlook Therapeutics and are subject to risks,
uncertainties and factors relating to its operations and business
environment, all of which are difficult to predict and many of
which are beyond its control. These risk factors include those
risks associated with developing pharmaceutical product candidates,
risks of conducting clinical trials and risks in obtaining
necessary regulatory approvals, the content and timing of decisions
by the FDA, as well as those risks detailed in Outlook
Therapeutics’ filings with the Securities and Exchange Commission
(the SEC), including the Annual Report on Form 10-K for the fiscal
year ended September 30, 2023, filed with the SEC on December 22,
2023, and future quarterly reports Outlook Therapeutics files with
the SEC, which include uncertainty of market conditions and future
impacts related to macroeconomic factors, including as a result of
the ongoing overseas conflict, high interest rates, inflation and
potential future bank failures on the global business environment.
These risks may cause actual results to differ materially from
those expressed or implied by forward-looking statements in this
press release. All forward-looking statements included in this
press release are expressly qualified in their entirety by the
foregoing cautionary statements. You are cautioned not to place
undue reliance on these forward-looking statements, which speak
only as of the date hereof. Outlook Therapeutics does not undertake
any obligation to update, amend or clarify these forward-looking
statements whether as a result of new information, future events or
otherwise, except as may be required under applicable securities
law.
Investor
Inquiries: Jenene
ThomasChief Executive OfficerJTC Team, LLCT:
833.475.8247 OTLK@jtcir.com
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