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 for ONS-5010
/ LYTENAVA™ (bevacizumab-vikg), the Company’s investigational
ophthalmic formulation of bevacizumab.
Outlook Therapeutics is currently conducting two
registration clinical trials for ONS-5010. At an End-of-Phase 2
meeting in April 2018, the U.S. Food and Drug Administration (FDA)
accepted the study design / size for the NORSE 1 and NORSE 2 trials
and confirmed that each of them is acceptable and may support a new
biologics license application (BLA) under the 351(a) regulatory
pathway toward approval for the treatment of wet age-related
macular degeneration (wet AMD).
“The remainder of 2020 is poised to be an
exciting year for Outlook Therapeutics and ONS-5010 as we approach
multiple major milestones in the coming quarter,” said Lawrence A.
Kenyon, President, CEO and CFO of the Company. “The agreed-upon
regulatory strategy with the FDA that includes the two registration
trials provides us with a streamlined and significantly de-risked
pathway towards approval. The first key milestone towards filing
our new BLA begins with the topline safety and efficacy results
from our NORSE 1 trial, which we expect to report in August, just
two months away. This study is expected to provide us with valuable
insight as to the safety of ONS-5010 dosed monthly in comparison to
the PIER quarterly dosing regimen of ranibizumab. We also will be
able to assess the first human efficacy data for ONS-5010 in wet
AMD. Although not pivotal data, these study results will help to
set the stage for NORSE 2.” The NORSE 1 clinical trial completed
enrollment in August 2019 and is on pace to report topline data in
August 2020. NORSE 1 enrolled a total of 61 treatment naïve and
previously treated patients at nine sites in Australia. NORSE 1
will provide initial safety and efficacy data for ONS-5010 in wet
AMD patients for ONS-5010 dosed monthly compared to LUCENTIS® dosed
using the PIER alternative dosing regimen of three monthly doses
followed by quarterly dosing.
“The next key element in our streamlined
regulatory pathway for ONS-5010 is our ongoing pivotal clinical
trial, NORSE 2, which remains on track to complete enrollment
within the next two months, with topline results expected in the
third calendar quarter of 2021,” added Mr. Kenyon. “Additionally,
we are preparing to initiate the NORSE 3 open-label study, which is
meant to ensure enough patients have been exposed to ONS-5010 to
meet the requirements for our planned BLA submission next year. We
expect to commence NORSE 3 in the fourth calendar quarter of
2020.”
The NORSE 2 clinical trial commenced patient
enrollment in July 2019 and is expected to enroll a total of
approximately 220 treatment naïve patients at more than 40 clinical
trial sites in the United States. NORSE 2 has currently enrolled
204 of the 220 patients. Patients in the trial will be treated for
12 months. The primary outcome of the study at Month 11 is a
statistically significant difference in the proportion of patients
who gain at least 15 letters in the best corrected visual acuity
for ONS-5010 over LUCENTIS®, which is being dosed quarterly per the
PIER regimen. The Company expects to report pivotal safety and
efficacy data in the third calendar quarter of 2021. The NORSE 3
open-label safety study will be conducted to ensure the adequate
number of safety exposures to ONS-5010 are available for the
initial regulatory filings. In total, approximately 180 patients
are expected to be enrolled in several different vascular and
inflammatory retinal diseases where an anti-VEGF drug can be used
as a therapeutic option. Patients in NORSE 3 will receive three
doses of ONS-5010 over three months.
In addition to NORSE 1 and NORSE 2 evaluating
ONS-5010 for wet AMD, Outlook Therapeutics has received agreements
from the FDA on three Special Protocol Assessments (SPAs), for
three additional registration clinical trials. These SPAs cover the
protocols for NORSE 4, a planned registration clinical trial
evaluating ONS-5010 to treat branch retinal vein occlusion or BRVO,
and NORSE 5 and NORSE 6, two planned registration clinical trials
evaluating ONS-5010 for the treatment of diabetic macular edema, or
DME.
“We believe there is a sizeable market
opportunity for ONS-5010 which, if approved, will be a
cGMP-produced, responsibly priced, on-label ophthalmic formulation
of bevacizumab to treat retinal diseases – an option that is not
currently available. We are dedicated to bringing ONS-5010 to
market as quickly and efficiently as possible so that patients can
benefit from the safety and reliability of an FDA-approved product,
and we look forward to providing you with additional updates in the
coming months,” concluded Mr. Kenyon.
The Company intends to complete development of
ONS-5010 for submission to the FDA as a new BLA under the 351(a)
PHSA regulatory pathway for the treatment of wet AMD. The Company
also has plans to submit for regulatory approvals in France, the
United Kingdom, Italy, Germany, Spain and Japan, as well as other
countries.
If approved, ONS-5010 will be the first and only
on-label ophthalmic formulation of bevacizumab for treating retinal
diseases and has the potential to address a $9.1 billion anti-VEGF
market. About ONS-5010 / LYTENAVA™
(bevacizumab-vikg)
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 adequate and well-controlled
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 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 (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 AMD, DME and 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. Outlook Therapeutics expects to file ONS-5010 with the
U.S. FDA as a new BLA under the PHSA 351(a) regulatory pathway. 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
ONS-5010’s potential, the timing of topline results from NORSE 1,
expected completion of NORSE 2 enrollment and timing of topline
results therefrom, commencement of NORSE 3 safety study and
anticipated enrollment, the timing of BLA submission and commercial
launch of ONS-5010, the ability of ONS-5010 to provide benefits to
patients, payors and physicians, and the benefits of having an FDA
approved bevacizumab, and plans for regulatory approvals in other
markets. 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, as
well as those risks detailed in the Company’s filings with the
Securities and Exchange Commission, which include the uncertainty
of future impacts related to the ongoing COVID-19 pandemic. 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
Investor
Inquiries:
Jenene Thomas Chief Executive Officer JTC Team, LLC T:
833.475.8247 OTLK@jtcir.com
Media Inquiries:Emmie TwomblyMedia Relations
SpecialistLaVoie Health ScienceM:
857.389.6042etwombly@lavoiehealthscience.com
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