Iveric Bio Completes Patient Enrollment of GATHER2 Pivotal Clinical Trial of Zimura® Ahead of Schedule
July 26 2021 - 7:30AM
Business Wire
- Topline Data Expected in 2H 2022; if
Positive, New Drug Application Expected -
IVERIC bio, Inc. (Nasdaq: ISEE) today announced the early
completion of patient enrollment of GATHER2, the Company’s second
pivotal clinical trial of Zimura® (avacincaptad pegol) in
development for the treatment of geographic atrophy (GA) secondary
to age-related macular degeneration (AMD). The Company expects
topline GATHER2 data to be become available during the second half
of 2022, approximately one year after the enrollment of the last
patient, plus the time needed for database lock and analysis.
“The time to complete enrollment in the Zimura GATHER2 clinical
trial was four months ahead of our original timeline. That we were
able to accomplish this during the unprecedented challenges
stemming from the global COVID-19 pandemic, we believe highlights
the unmet need of patients and physicians for a treatment of GA
secondary to AMD,” stated Glenn P. Sblendorio, Chief Executive
Officer of Iveric Bio. “Patient retention continues to exceed our
expectations in GATHER2. We look forward to sharing the topline
results of GATHER2 in the second half of 2022 and to the potential
opportunity to bring Zimura therapy to GA secondary to AMD patients
around the world.”
In June 2021, the Company announced that it is targeting patient
retention for the trial, as measured by the injection fidelity rate
through month 12, of greater than 90%. Injection fidelity is
calculated by dividing the total number of actual injections by the
total number of expected injections based on the number of enrolled
patients. The Company considers injection fidelity to be the most
important component of patient retention because it reflects the
timely administration of the drug into the patient’s eye.
The Company also announced earlier this month that it received
written agreement from the U.S. Food and Drug Administration (FDA)
under a Special Protocol Assessment (SPA) for the overall design of
GATHER2. The agreement further solidifies the Company’s plans to
file an application with the FDA for marketing approval of Zimura
for GA secondary to AMD, if the ongoing GATHER2 clinical trial
meets its primary endpoint at 12 months. Zimura met its
pre-specified primary efficacy endpoint at 12 months and reached
statistical significance in the previously completed GATHER1
pivotal clinical trial.
“The successful completion of enrollment ahead of schedule and
on-going patient retention in GATHER2 reflect the tremendous work
and innovative programs our clinical team has executed and are a
tribute to our patients, investigators and their study staff,”
stated Pravin U. Dugel, President of Iveric Bio. “This milestone
would have been impressive at any time however it is more
impressive during a global pandemic. We continue to focus on
retention, not only to protect the integrity of our data, but also
with the goal of demonstrating Zimura’s early and continuous
treatment effect over time, similar to what we observed previously
in GATHER1.”
In GATHER2, 448 patients were randomized to receive either
monthly administration of Zimura 2 mg or sham during the first 12
months of the trial, at which time the primary efficacy analysis of
the mean rate of change of GA growth (slope) at 12 months will be
performed. If the 12 month results are positive, the Company plans
to file an application with the U.S. Food and Drug Administration
and the European Medicines Agency for marketing approval of Zimura
for GA following receipt of that data. At month 12, the Company
plans to re-randomize patients in the Zimura 2 mg arm to receive
either monthly or every other month administration of Zimura 2 mg.
The final evaluation will take place at month 24.
About Zimura
Zimura (avacincaptad pegol) is an investigational drug product
and has not been approved for use anywhere globally. Zimura is
designed to target and inhibit the cleavage of complement protein
C5 and the formation of its downstream fragments, C5a and C5b. By
inhibiting the formation of these fragments, Zimura is believed to
decrease or slow the chronic inflammation and cell death associated
with the retinal aging process by decreasing the formation of
membrane attack complex (MAC) and inflammasome activity, thereby
potentially avoiding or slowing the degeneration of retinal pigment
epithelial cells. This potential mechanism is the rationale for
Zimura as a potential therapy for geographic atrophy secondary to
age-related macular degeneration.
About Iveric Bio
Iveric Bio is a science-driven biopharmaceutical company focused
on the discovery and development of novel treatment options for
retinal diseases with significant unmet medical needs. The Company
is currently developing both therapeutic product candidates for
age-related retinal diseases and gene therapy product candidates
for orphan inherited retinal diseases. For more information on the
Company, please visit www.ivericbio.com.
Forward-looking Statements
Any statements in this press release about the Company’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 the Company’s strategy,
future operations and future expectations and plans and prospects
for the Company, and any other statements containing the words
“anticipate,” “believe,” “estimate,” “expect,” “intend”, “goal,”
“may”, “might,” “plan,” “predict,” “project,” “seek,” “target,”
“potential,” “will,” “would,” “could,” “should,” “continue,” and
similar expressions. In this press release, the Company’s forward
looking statements include statements about the Company’s
development and regulatory strategy for Zimura, including its
strategy to seek marketing approval from the FDA and EMA for Zimura
for the treatment of GA secondary to AMD if the ongoing GATHER2
clinical trial meets its primary endpoint at 12 months, the timing,
progress and results of clinical trials, including expectations
regarding patient retention in, and the availability of topline
data from, GATHER2, and other research and development activities
and the potential utility of Zimura. Such forward-looking
statements involve substantial risks and uncertainties that could
cause the Company’s 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
expectations for regulatory matters, the progression and duration
of the COVID-19 pandemic and responsive measures thereto and
related effects on the Company’s research and development programs,
operations and financial position, the initiation and the progress
of research and development programs and clinical trials,
availability of data from these programs, reliance on clinical
trial sites, contract research organizations and other third
parties, establishment of manufacturing capabilities, need for
additional financing and negotiation and consummation of business
development transactions and other factors discussed in the “Risk
Factors” section contained in the quarterly and annual reports that
the Company files with the Securities and Exchange Commission. Any
forward-looking statements represent the Company’s views only as of
the date of this press release. The Company anticipates that
subsequent events and developments may cause its views to change.
While the Company may elect to update these forward-looking
statements at some point in the future, the Company specifically
disclaims any obligation to do so except as required by law.
ISEE-G
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version on businesswire.com: https://www.businesswire.com/news/home/20210726005153/en/
Investor Contact: Iveric Bio Kathy Galante, 212-845-8231
Senior Vice President, Investor Relations
kathy.galante@ivericbio.com
or
Media Contact: SmithSolve Alex Van Rees, 973-442-1555
ext. 111 alex.vanrees@smithsolve.com
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