Ophthotech Announces First Patient Enrolled in the Phase 2b Clinical Trial of Zimura®, Complement C5 Inhibitor, for the Trea...
January 16 2018 - 7:30AM
Business Wire
- One of the Largest Interventional Clinical
Trials for the Treatment of STGD1, an Inherited Orphan Retinal
Disease –
- Zimura Is Also Being Investigated in Ongoing
Clinical Trials for the Treatment of Dry and Wet Age-related
Macular Degeneration (AMD) and Idiopathic Polypoidal Choroidal
Vasculopathy (IPCV) -
Ophthotech Corporation (NASDAQ:OPHT) announced today that the
first patient has been enrolled in the Phase 2b randomized,
double-masked, sham-controlled clinical trial assessing the
efficacy and safety of Zimura® (avacincaptad pegol), complement C5
inhibitor, in patients with autosomal recessive Stargardt disease
(STGD1). STGD1 is an inherited orphan retinal disease causing
vision loss during childhood or adolescence. Currently there are no
FDA or EMA approved treatment options available for patients with
STGD1. Over 30 sites have been identified for this clinical trial,
making it one of the largest interventional clinical trials for
STGD1 to date. The scientific details of the Stargardt clinical
trial will be presented at the 2018 Annual Meeting of the
Association for Research in Vision and Ophthalmology (ARVO) in
Honolulu, Hawaii.
“We are excited to focus and accelerate the development of
Zimura in Stargardt disease,” stated Glenn P. Sblendorio, Chief
Executive Officer and President of Ophthotech. “We look forward to
2018 with our ongoing clinical programs in dry AMD, wet AMD and
IPCV. We continue our search for new opportunities that are in sync
with our commitment to develop novel therapeutics for age-related
and orphan diseases in the back of the eye.”
“Recent scientific literature emphasizes the role of complement
in Stargardt disease, supporting our strategy for the development
of Zimura in this devastating orphan retinal condition,” stated
Kourous A. Rezaei, M.D., Senior Vice President and Chief Medical
Officer of Ophthotech. “Our work with the highly-distinguished
organization, Foundation Fighting Blindness, provided us access to
publicly available data from ProgStar, the largest natural history
study in autosomal recessive Stargardt disease to date, playing an
integral role in the design of our clinical trial.”
“Autosomal recessive Stargardt disease is a devastating orphan
retinal disease for which there is currently no treatment,” stated
Benjamin Yerxa, PhD, Chief Executive Officer of Foundation Fighting
Blindness. “We are excited that Ophthotech has joined the mission
to fight against orphan degenerative retinal diseases as both
organizations share the common goal of transforming the lives of
these patients and their families by developing potential new
treatments.”
The Company expects to enroll approximately 120 patients in this
trial and plans to use an anatomic endpoint, the mean rate of
change in the area of ellipsoid zone defect as measured by en face
spectral domain optical coherence tomography (SD-OCT), as the
primary endpoint, which will be assessed at 18 months. Initial
top-line data is expected to be available in 2020.
Ophthotech also announced that it has initiated an open-label
Phase 2a clinical trial evaluating Zimura in combination with
anti-vascular endothelial growth factor (VEGF) therapy for
idiopathic polypoidal choroidal vasculopathy (IPCV), an age-related
retinal disease. Approximately 20 patients will be enrolled and
treated for a duration of 9 months. Initial top-line data is
expected to be available during the second half of 2019.
Zimura in Geographic Atrophy, a Severe Form of Dry
AMD
An ongoing randomized, double-masked, sham-controlled Phase 2b
clinical trial is designed to assess the safety and efficacy of
Zimura monotherapy in patients with geographic atrophy (GA)
secondary to dry AMD. The Company plans to enroll approximately 200
patients in this trial. The primary efficacy endpoint is the mean
rate of change in GA over 12 months. Patients will be treated and
monitored for 18 months. A range of Zimura dosing regimens will be
assessed. Initial, top-line data is expected to be available during
the second half of 2019.
Zimura in Wet AMD
An ongoing dose-ranging, open-label Phase 2a clinical trial of
Zimura in combination with Lucentis® will enroll approximately 60
patients with wet AMD who have not been previously treated with any
anti-VEGF agents, who will be treated for a duration of 6 months.
Based on the anticipated enrollment rate, the Company expects
initial top-line data from this trial to be available by the end of
2018.
About Zimura
Zimura is designed to target and inhibit the complement protein
C5. Zimura binds to and inhibits C5 from being cleaved into C5a and
C5b, potentially preventing the formation of inflammasomes and the
accumulation of membrane attack complex (MAC), preventing cell
death. Further, when used in combination with anti-VEGF therapy,
Zimura may counteract the anti-VEGF induced complement
upregulation, thereby providing the rationale as a potential
combination therapy for patients with wet AMD and IPCV.
About Ophthotech Corporation
Ophthotech is a biopharmaceutical company specializing in the
development of novel therapeutics for age-related and orphan
diseases of the eye. For more information, please visit
www.ophthotech.com.
Forward-looking Statements
Any statements in this press release about Ophthotech’s future
expectations, plans and prospects constitute forward-looking
statements for purposes of the safe harbor provisions under the
Private Securities Litigation Reform Act of 1995. Forward-looking
statements include any statements about Ophthotech’s strategy,
future operations and future expectations and plans and prospects
for Ophthotech, and any other statements containing the words
“anticipate,” “believe,” “estimate,” “expect,” “intend”, “goal,”
“may”, “might,” “plan,” “predict,” “project,” “target,”
“potential,” “will,” “would,” “could,” “should,” “continue,” and
similar expressions. In this press release, Ophthotech’s
forward-looking statements include statements about the timing,
progress and results of clinical trials and other development
activities, the potential clinical utility of its product
candidates, and the potential for its business development
strategy. Such forward-looking statements involve substantial risks
and uncertainties that could cause Ophthotech’s clinical
development programs, future results, performance or achievements
to differ significantly from those expressed or implied by the
forward-looking statements. Such risks and uncertainties include,
among others, those related to the initiation and conduct of
clinical trials, availability of data from clinical trials,
expectations for regulatory matters, need for additional financing
and negotiation and consummation of in-license and/or acquisition
transactions and other factors discussed in the “Risk Factors”
section contained in the quarterly and annual reports that
Ophthotech files with the Securities and Exchange Commission. Any
forward-looking statements represent Ophthotech’s views only as of
the date of this press release. Ophthotech anticipates that
subsequent events and developments will cause its views to change.
While Ophthotech may elect to update these forward-looking
statements at some point in the future, Ophthotech specifically
disclaims any obligation to do so except as required by law.
OPHT-G
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version on businesswire.com: http://www.businesswire.com/news/home/20180116005381/en/
Ophthotech CorporationInvestorsKathy Galante,
212-845-8231Vice President, Investor Relations and Corporate
Communicationskathy.galante@ophthotech.comorMediaAlex Van
Rees, 973-442-1555 ext. 111SmithSolve LLC on behalf
of Ophthotech Corporationalex.vanrees@smithsolve.com
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