Ophthotech Provides Update on Zimura® Complement Programs for Treatment of Eye Diseases
September 19 2017 - 7:00AM
Business Wire
- Company Initiates Phase 2a Clinical Trial in
Patients with Wet Age-related Macular Degeneration -
- Clinical Trials in Stargardt Disease and
Idiopathic Polypoidal Choroidal Vasculopathy on Schedule to
Initiate Before the End of the Year -
- Company Modifies Plan for Study in Geographic
Atrophy, a form of Dry Age-related Macular Degeneration -
Ophthotech Corporation (NASDAQ: OPHT) announced today the
initiation of an open-label Phase 2a clinical trial of Zimura®
(avacincaptad pegol), the Company’s complement factor C5 inhibitor,
in patients with wet age-related macular degeneration (AMD). Zimura
will be administered in combination with Lucentis® (ranibizumab),
an anti-vascular endothelial growth factor (anti-VEGF), in patients
with wet AMD who have not been previously treated with anti-VEGF
drugs. A range of Zimura dosing regimens will be assessed. Clinical
trial sites have been identified and activated.
“We believe that supplementing anti-VEGF therapy with a
complement inhibitor such as Zimura may have the potential to
further enhance the efficacy of anti-VEGF monotherapy in wet AMD,”
stated Kourous A. Rezaei, M.D., Senior Vice President of Medical
Strategy. “Our earlier Phase 1/2a clinical trial assessing Zimura
in combination with Lucentis, while small and uncontrolled, showed
intriguing results. A recent peer-reviewed publication from the
Journal of Clinical Investigation from Scripps Research Institute
provided further support that anti-VEGF therapy upregulates
complement activation and therefore that complement inhibition
during anti-VEGF therapy may have therapeutic merit. These findings
establish a foundation to pursue further development of Zimura in
wet AMD.”
“We are excited to move the Company forward with opportunities
consistent with our overall strategy to develop Zimura for both
orphan diseases and larger indications in the back of the eye, such
as age-related retinal diseases,” stated Glenn P. Sblendorio, Chief
Executive Officer and President of Ophthotech.
The Company also announced that it remains on track to initiate
two additional Zimura clinical trials before the end of the year.
The Company’s strategy in orphan indications will be led by a
randomized, controlled clinical trial to assess Zimura monotherapy
in Stargardt disease, a devastating orphan retinal disease-causing
vision loss during childhood or adolescence. The other trial will
be an open-label Phase 2a clinical trial evaluating Zimura in
combination with anti-VEGF therapy for idiopathic polypoidal
choroidal vasculopathy (IPCV), an age-related eye disease.
Ophthotech is also planning a Phase 2a clinical trial of Zimura
monotherapy for intermediate/posterior non-infectious uveitis, an
orphan inflammatory disease of the back of the eye. This trial is
planned to initiate in 2018.
The Company is in the process of modifying its dry AMD program.
Following the recent announcements of competitors’ conflicting
topline results from two clinical trials assessing the role of two
different types of complement inhibitors, one blocking the
alternative complement pathway (did not meet primary endpoint) and
the other blocking all three complement pathways (met primary
endpoint), in the treatment of geographic atrophy, a dry form of
AMD, Ophthotech has decided to modify its ongoing Phase 2/3
clinical trial of Zimura monotherapy (which blocks all three
complement pathways) in geographic atrophy. Ophthotech had
originally planned to enroll 300 patients in an initial stage of
the ongoing trial, with an interim analysis scheduled for the
18-month time point, and to potentially enroll up to an additional
600 patients thereafter. The trial will be modified to accelerate
the anticipated timeline to obtain topline data by reducing the
number of patients, shortening the time point for attaining the
primary efficacy endpoint and thereby reducing the cost to complete
the study. The modified study design will incorporate patients
already enrolled in the study.
About ZimuraZimura is
designed to target and inhibit the complement protein C5, a central
component of the complement cascade. Inhibition of C5 in the
complement cascade prevents the formation of key terminal fragments
(C5a and C5b-9) regardless of which of the three complement
pathways (classical, lectin or alternative) induced their
generation. C5b-9 is involved in the formation of the membrane
attack complex (MAC: C5b-9), which can cause cell death through
disruption of the cell membrane. By inhibiting the terminal steps
of complement activation at the level of C5, we believe a
therapeutic benefit may be achieved.
About Ophthotech CorporationOphthotech is a
biopharmaceutical company specializing in the development of novel
therapeutics for diseases of the eye. For more information, please
visit www.ophthotech.com.
Forward-looking StatementsAny 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 implementation of its strategic plan,
Ophthotech's projected use of cash and cash balances, the timing,
progress and results of clinical trials and other development
activities, and the potential utility or commercialization of any
of Ophthotech’s product candidates. 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 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/20170919005345/en/
InvestorsOphthotech CorporationKathy Galante,
212-845-8231Vice President, Investor Relations and Corporate
Communicationskathy.galante@ophthotech.comorMediaSmithSolve
LLC on behalf of Ophthotech CorporationAlex Van Rees,
973-442-1555 ext. 111alex.vanrees@smithsolve.com
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