NGM Biopharmaceuticals, Inc. (NGM) (Nasdaq: NGM), a biotechnology
company focused on discovering and developing transformative
therapeutics for patients, today announced it has initiated the
Phase 2 CATALINA study, a multicenter, randomized, double-masked,
sham-controlled clinical trial, to evaluate the safety and efficacy
of intravitreal injections (IVT) of NGM621 in patients with
geographic atrophy (GA) secondary to age-related macular
degeneration (AMD). GA, an advanced form of AMD, is a progressive
retinal degenerative disease associated with irreversible loss of
vision, diminished quality of life and eventual blindness.
Dysregulated activation of the complement system, a key component
of the immune system, has been implicated in the onset and
progression of GA. NGM621 is a humanized IgG1 monoclonal antibody
engineered to potently inhibit activity of complement C3 with the
treatment goal of reducing disease progression in patients with GA,
and with the potential for every eight week dosing.
“The NGM621 program exemplifies our strategy to target powerful,
disease-driving biology to deliver transformative medicines for
patients across a range of therapeutic areas and diseases with high
unmet need,” Hsiao D. Lieu, M.D., Chief Medical Officer at NGM Bio.
“We are very encouraged by the preclinical data and Phase 1 safety
and tolerability data for NGM621. Recognizing the severe,
life-altering impact GA has on patients’ lives, we are working to
rapidly advance NGM621 through clinical development. We believe
NGM621 offers a unique profile with best-in-class potential and
could represent an important therapeutic advance for patients with
GA.”
NGM621 was discovered by NGM under its strategic collaboration
with Merck. NGM successfully completed a first-in-human open-label
Phase 1 study in which treatment with single- and multiple-dose IVT
injections of NGM621 in patients with GA was well tolerated,
supporting continued development. NGM plans to present the data
from the Phase 1 study at an upcoming medical conference. NGM
recently presented NGM621 preclinical findings at The Association
for Research in Vision and Ophthalmology (ARVO) Annual Meeting,
held virtually in June 2020. The presentations are available on
NGM’s website here.
“As a retina specialist who manages patients with GA, I see
first-hand the progressive and eventually devastating impact this
disease can have on patients’ quality of life. The insidious loss
of vision leads to difficulty with everyday tasks and social
isolation, in many cases robbing patients of their independence and
ability to do things they enjoy. Often these patients live in fear
of going blind, knowing that currently nothing can be done to slow
their disease progression,” said Charles C. Wykoff, M.D., Ph.D.,
Director of Research at Retina Consultants Houston and the Greater
Houston Retina Research Foundation. “Complement inhibition
continues to be a promising approach to slowing GA progression. I
am pleased to see NGM621 move into a rigorous Phase 2 study and am
encouraged by the data to date with this antibody that blocks C3
activation. I look forward to seeing how NGM621’s C3 inhibition
translates into clinical benefit.”
About the NGM621 Phase 2 CATALINA Study
Design
Designed as a Phase 3-enabling study, the Phase 2 CATALINA study
will enroll 240 patients diagnosed with GA in one or both eyes. The
primary objectives of this multicenter, randomized, double-masked,
sham-controlled study are to evaluate the efficacy and safety of
NGM621 IVT injections compared to sham control. Patients will be
randomized to one of four treatment groups in a ratio of 2:1:2:1 to
receive IVT injections of NGM621 or sham every four weeks or every
eight weeks for a total of 48 weeks, and monitored for an
additional four weeks upon treatment completion. The primary
efficacy endpoint is change from baseline in the square root of GA
lesion area at 48 weeks, as measured by fundus autofluorescence
(FAF) imaging compared to sham control. The primary safety
endpoints will evaluate the incidence and severity of ocular and
systemic adverse events from treatment with NGM621 compared to sham
control.
For more information, please visit the study listing on
clinicaltrials.gov.
About NGM621 and Complement C3 Inhibition
NGM621 is a humanized IgG1 monoclonal antibody engineered to
potently inhibit complement C3, with the potential for extended
every eight week dosing without pegylation. In preclinical models,
NGM621’s high affinity binding to C3 has demonstrated the potential
for potent C3 inhibition. In addition, in well validated animal
models of laser-induced choroidal neovascularization (CNV), C3
inhibition has demonstrated the ability to reduce retinal vascular
leakage, suggesting the potential for NGM621 to prevent CNV
development.
C3 is a key component of the complement system, which helps
orchestrate the body’s response to infection and maintains tissue
homeostasis. The complement cascade can be activated through its
three distinct pathways – classical, lectin and alternative – all
of which converge to activate C3. When this cascade is
dysregulated, the immune response may lead to the development and
progression of GA. Inhibition of C3 represents a promising
therapeutic approach that broadly inhibits downstream effector
functions triggered by the excessive activation of C3, including
inflammation, activation of the adaptive immune system,
opsonization (the marking of a pathogen to be destroyed by
phagocytes, a type of immune cell), phagocytosis and cell lysis
(cell death).
About AMD and GA
AMD is a leading cause of vision loss and blindness in people
over the age of 65 in the US and other industrialized countries.i
The two advanced stages of the disease are called neovascular (wet)
AMD and geographic atrophy.
GA is estimated to impact about 1 million people in the USii and
over 5 million people worldwideiii. In patients with GA, single or
multiple areas in the macular region of the retina become atrophic,
forming distinct lesions that expand and coalesce over time.
Enlargement of these lesions can lead to loss of vision and
irreversible blindness. GA is often bilateral, meaning it occurs in
both eyes. While there are approved treatments for wet AMD, there
are currently no approved treatments for GA.
About NGM Biopharmaceuticals, Inc.
NGM is a biopharmaceutical company focused on discovering and
developing novel therapeutics based on scientific understanding of
key biological pathways underlying cardio-metabolic, liver,
oncologic and retinal diseases. We leverage our biology-centric
drug discovery approach to uncover novel mechanisms of action and
generate proprietary insights that enable us to move rapidly
into proof-of-concept studies and deliver
potential first-in-class medicines to patients. At NGM,
we aspire to operate one of the most productive research and
development engines in the biopharmaceutical industry, with
multiple programs in clinical development. Visit us
at www.ngmbio.com for more information.
Forward-Looking Statements
Statements contained in this press release regarding matters
that are not historical facts are “forward-looking statements”
within the meaning of the Private Securities Litigation Reform Act
of 1995. Words such as “with the goal of,” “engineered to,”
“working to,” “advance,” “potential,” “target,” “believe,” “could,”
“plans,” “will,” “look forward,” “aspire” and similar expressions
(as well as other words or expressions referencing future events,
conditions or circumstances) are intended to identify
forward-looking statements. These statements include those related
to: NGM’s strategy to deliver transformative medicines for patients
across a range of therapeutic areas through the clinical
development of NGM621 and other product candidates; the design,
timing, enrollment and potential results of NGM’s Phase 2
CATALINA study of NGM621 for the treatment of patients with GA
secondary to AMD; the potential of NGM621 as a best-in-class
product candidate for the treatment of patients with GA; the
potential therapeutic effects, benefits and dosing schedule of
NGM621 and the role of NGM621 as a potential potent C3 inhibitor
that may reduce disease progression in patients with GA; NGM’s
plans to present the data from its completed Phase 1 study at an
upcoming medical conference; and other statements that are not
historical fact. Because such statements deal with future events
and are based on NGM’s current expectations, they are subject to
various risks and uncertainties, and actual results, performance or
achievements of NGM could differ materially from those described in
or implied by the forward-looking statements in this press release.
These risks and uncertainties include, without limitation, risks
and uncertainties associated with: the costly and time-consuming
pharmaceutical product development process and the uncertainty of
clinical success, including risks related to failure or delays in
receiving regulatory clearance for, enrolling or completing
clinical studies and the risk that NGM’s clinical studies in humans
may show that NGM621 is not a safe and effective treatment for
patients with GA; the risk that the results obtained to date in
NGM’s clinical trials may not be indicative of results obtained in
pivotal or other late-stage trials; the evolving effects of the
COVID-19 pandemic, which may significantly impact (i) our business
and operations, including activities at our headquarters in the San
Francisco Bay Area and our clinical trial sites, as well as the
business or operations of our manufacturers, contract research
organizations or other third parties with whom we conduct business,
(ii) our ability to access capital and (iii) the value of our
common stock; the time-consuming and uncertain regulatory approval
process; NGM’s reliance on third-party manufacturers for NGM621 and
its other product candidates; the sufficiency of NGM’s cash
resources and need for additional capital; and other risks and
uncertainties affecting NGM and its development programs, including
those described under the caption “Risk Factors” in NGM’s quarterly
report on Form 10-Q for the quarter ended March 31, 2020 and future
filings and reports that NGM makes from time to time with the
United States Securities and Exchange Commission. Except as
required by law, NGM assumes no obligation to update these
forward-looking statements, or to update the reasons if actual
results differ materially from those anticipated in the
forward-looking statements.
Investor Contact:Sylvia Wheeler and Alexandra
Santosswheeler@wheelhouselsa.comasantos@wheelhouselsa.comir@ngmbio.com |
Media Contact:Liz Melonemedia@ngmbio.com |
________________________
i Flaxman SR, Bourne RRA, Resnikoff S, et al. Global causes of
blindness and distance vision impairment 1990-2020: a systematic
review and meta-analysis. Lancet Glob Health. 2017;5(12):
1221-1234.
ii Friedman DS, O’Colmain BJ, Munoz B, et al. Prevalence of
age-related macular degeneration in the United States. Arch
Ophthalmol. 2004;122(4):564-572.
iii Wong WL, Su X, Li X, et al. Global prevalence of age-related
macular degeneration and disease burden projection for 2020 and
2040; a systematic review and meta-analysis. Lancet 2014;
2:e106-116.
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