Outlook Therapeutics Provides COVID-19 Impact Update on Ongoing Clinical Trials NORSE 1 and NORSE 2
April 14 2020 - 8:05AM
Outlook Therapeutics, Inc. (NASDAQ: OTLK) (the “Company”), a late
clinical-stage biopharmaceutical company working to develop the
first FDA-approved ophthalmic formulation of bevacizumab for use in
retinal indications, today provided a clinical update on the impact
of the COVID-19 pandemic on the status of NORSE 1 and NORSE 2, its
ongoing registration clinical trials for ONS-5010 / LYTENAVA™
(bevacizumab-vikg), an investigational ophthalmic formulation of
bevacizumab.
All clinical and chemistry, manufacturing and control (CMC)
activities are currently active for both NORSE 1 and NORSE 2,
registration clinical trials evaluating ONS-5010 for treatment of
wet age-related macular degeneration (wet AMD). The Company
has confirmed with the Ophthalmic Division of the U.S. Food and
Drug Administration (FDA) that it considers both approved and
investigational treatments for sight-threatening conditions such as
wet AMD not to be elective, and that as such they should continue
during the COVID-19 restrictions.
NORSE 1 completed enrollment in August 2019 and is on pace to
meet its schedule as expected. The Company anticipates
reporting data during the third calendar quarter of 2020. At this
time, COVID-19 is not expected to affect the completion of NORSE 1
and anticipated data readout date.
NORSE 2, which commenced enrollment in July 2019 and is being
conducted in the United States, continues to screen, enroll and
treat patients, subject to additional COVID-19 safety protocols for
both patients and staff at trial sites. Due to these additional
safety protocols, some sites have temporarily shut down and patient
enrollment has slowed. Outlook estimates that final enrollment
could be delayed by one to three months, depending on local
conditions, which have varying degrees of “shelter-in-place” and
other type of executive orders mandating various restrictions.
“In these unprecedented times across the globe, the safety of
the patients and medical staff engaged in our NORSE 1 and NORSE 2
clinical trials is our top priority. We are fortunate enough not to
expect any delay in our NORSE 1 clinical trial and anticipate
reporting data from the study in August of this year, as planned.
We want to share our deepest appreciation to all medical staff and
patients for their ongoing participation in this important clinical
work,” said Lawrence A. Kenyon, President, CEO and CFO, Outlook
Therapeutics. “While the full impact of COVID-19 remains uncertain,
we are confident that the statistical analysis plans we have built
into the NORSE 2 clinical trial will mitigate potential missed
visits and the slower pace of enrollment we are currently
experiencing. Our team remains dedicated to advancing the program
efficiently while minimizing delays as much as possible.”
About ONS-5010 / LYTENAVA™
ONS-5010 / LYTENAVA™ (bevacizumab-vikg) is an investigational
ophthalmic formulation of bevacizumab under development to be
administered as an intravitreal injection for the treatment of wet
AMD and other retinal diseases. ONS-5010 is currently being
evaluated in two registration clinical trials for wet AMD (NORSE 1
and NORSE 2) and, if successful, is expected to be submitted to the
FDA as a new BLA for this ophthalmic indication. If approved,
ONS-5010 will be the first and only FDA-approved ophthalmic
formulation of bevacizumab to treat approved retinal diseases. The
Company currently intends to commercialize ONS-5010 in both vials
and single-use pre-filled syringes.
ONS-5010 is a full-length, humanized anti-VEGF (Vascular
Endothelial Growth Factor) recombinant monoclonal antibody (or mAb)
that inhibits VEGF and associated angiogenic
activity. With wet AMD, abnormally high levels of VEGF are
secreted in the eye. VEGF is a protein that promotes the growth of
new abnormal blood vessels. Anti-VEGF injection therapy blocks this
growth. Since the advent of anti-VEGF therapy, it has become the
standard of care treatment option within the retina community
globally.
About Outlook Therapeutics,
Inc.
Outlook Therapeutics is a late clinical-stage biopharmaceutical
company working to develop the first FDA-approved ophthalmic
formulation of bevacizumab for use in retinal indications,
including wet age-related macular degeneration (wet AMD), diabetic
macular edema (DME) and branch retinal vein occlusion (BRVO). If
ONS-5010 / LYTENAVA™ (bevacizumab-vikg), its investigational
ophthalmic formulation of bevacizumab, is approved, Outlook
Therapeutics expects to commercialize it as the first and only
approved ophthalmic formulation of bevacizumab for use in treating
approved retinal diseases in the United States, Europe, Japan and
other markets. 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 “may,” “might,” “will,” “should,” “expect,”
“plan,” “anticipate,” “project,” “believe,” “estimate,” “predict,”
“potential,” “intend” or “continue,” the negative of terms like
these or other comparable terminology, and other words or terms of
similar meaning. These include statements about its plans for
filing a BLA for ONS-5010 / LYTENAVA™ (bevacizumab-vikg), its
commercialization plans for ONS-5010, expected data read-out dates
for NORSE 1, and the impact of the COVID-19 pandemic on its ongoing
ONS-5010 clinical trials. Although the Company believes that it has
a reasonable basis for forward-looking statements contained herein,
they are based on current expectations about future events
affecting the Company 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 uncertainty regarding the COVID-19 pandemic and its
duration, as well as those risks detailed in the Company’s filings
with the Securities and Exchange Commission. 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.
The Company 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.
For additional details on the Company’s financial performance
during the quarter, please see the Company’s filings with
the Securities and Exchange Commission.
CONTACTS: Outlook
Therapeutics:
Lawrence A. Kenyon LawrenceKenyon@outlooktherapeutics.com
Media Inquiries:Emmie TwomblyMedia Relations
SpecialistLaVoie Health ScienceM:
857.389.6042etwombly@lavoiehealthscience.com
Investor
Inquiries:
Jenene Thomas Chief Executive Officer JTC Team, LLC T:
833.475.8247 OTLK@jtcir.com
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