NGM Bio’s NGM621 Receives Fast Track Designation from the FDA for the Treatment of Patients with Geographic Atrophy Secondary to Age-Related Macular Degeneration
February 07 2022 - 8:00AM
NGM Biopharmaceuticals, Inc. (NGM Bio) (Nasdaq: NGM), a
biotechnology company focused on discovering and developing
transformative therapeutics for patients, today announced that the
U.S. Food and Drug Administration (FDA) has granted Fast Track
designation to NGM621, a monoclonal antibody product candidate
engineered to potently inhibit complement C3, for the treatment of
patients with geographic atrophy (GA) secondary to age-related
macular degeneration. NGM Bio is currently evaluating NGM621 in its
ongoing Phase 2 CATALINA study and a topline data readout is
expected in the fourth quarter of 2022.
“The FDA’s decision to grant Fast Track designation to NGM621 is
an important milestone underscoring the high unmet medical need for
patients with geographic atrophy as well as the potential of NGM621
to alter the course of this disease for those underserved
patients,” stated Erin Henry Ph.D., Head of Ophthalmology at NGM
Bio. “Patients living with geographic atrophy lose approximately
one line of vision on the eye chart each year, impacting their
ability to do everyday tasks such as driving and reading and
reducing their independence and quality of life. We are committed
to improving outcomes for these patients and this designation, with
its potential for more frequent interactions with the FDA, may help
accelerate our efforts to do so.”
The Fast Track process was designed by the FDA to facilitate the
development and expedite the review of potential therapeutics
intended to treat serious conditions and address unmet medical
needs. Fast Track-designated programs are given the opportunity to
engage in early and frequent communication with the FDA throughout
the entire development and review process and may be eligible for
prioritized review and accelerated approval if relevant criteria
are met.
About Geographic Atrophy (GA)
GA is an advanced form of age-related macular degeneration
characterized by progressive retinal cell loss that results in
irreversible loss of vision. The disease affects approximately one
million patients in the U.S. and five million patients globally.
There are currently no treatments for GA approved by the FDA or the
European Medicines Agency.
About NGM621 and Complement C3 Inhibition
NGM621 is a proprietary humanized Immunoglobulin 1 monoclonal
antibody product candidate engineered to potently bind to, and be a
long-acting inhibitor of, complement C3 activity. The therapeutic
is delivered via intravitreal (IVT) injection and is being
evaluated with dosing intervals of every four and eight weeks.
NGM621 Phase 1 study results showed single and multiple IVT
injections appeared to be safe and well tolerated
(clinicaltrials.gov identifier: NCT04014777). In preclinical
models, NGM621’s high affinity binding to C3 has demonstrated the
potential for potent C3 inhibition, and NGM Bio’s
pharmacokinetics/pharmacodynamics modeling has shown sufficient
drug coverage for potential every-eight-week dosing. NGM Bio’s
preclinical data also suggest that NGM621, unlike PEGylated
molecules, may not exacerbate choroidal neovascularization (CNV);
the human translation of this observation is being investigated in
the fully enrolled, ongoing Phase 2 CATALINA clinical trial
(clinicaltrials.gov identifier: NCT04465955).
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 the complement
pathway, 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).
NGM621 was discovered by NGM Bio under its strategic
collaboration with Merck, known as MSD outside the United
States and Canada.
About the NGM621 Phase 2 CATALINA Study
The Phase 2 CATALINA study enrolled 320 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 when given every four weeks or
every eight weeks via IVT injections compared to sham control.
Patients are 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 52 weeks and monitored
for an additional four weeks upon treatment completion for a total
of 56 weeks. The primary efficacy endpoint is the rate of change in
GA lesion area, as measured by fundus autofluorescence (FAF)
imaging, over 52 weeks of treatment. 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 (identifier: NCT04465955).
About NGM Biopharmaceuticals, Inc.
NGM Bio is focused on discovering and developing novel,
life-changing medicines for people whose health and lives have been
disrupted by disease. The company’s biology-centric drug discovery
approach aims
to seamlessly integrate interrogation of complex
disease-associated biology and protein engineering expertise to
unlock proprietary insights that are leveraged to generate
promising product candidates and enable their rapid advancement
into proof-of-concept studies. As explorers on the frontier of
life-changing science, NGM Bio aspires to operate one of the most
productive research and development engines in the
biopharmaceutical industry. All therapeutic candidates in the NGM
Bio pipeline have been generated by its in-house discovery engine,
with a disease-agnostic mindset, always led by biology and
motivated by unmet patient need. Today, the company has seven
disclosed programs, including four in Phase 2 or 2b
studies, across three therapeutic areas:
cancer, retinal diseases and liver and
metabolic diseases. Visit us at www.ngmbio.com for more
information.
Forward Looking StatementsStatements 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,” “anticipates,” “may,”
“suggest,” “potential,” “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 Bio’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 potential for early and more frequent interactions
with the FDA; the design, timing and potential results of NGM Bio’s
Phase 2 CATALINA study of NGM621; the availability of Phase 2
CATALINA study topline data readout in the fourth quarter of 2022;
the ability of NGM621 to serve as an innovative treatment option
for patients with GA; the potential for every-eight-week dosing of
NGM621 and the suggestion that NGM621 may not exacerbate CNV; the
potential of NGM621 to change disease trajectory and slow disease
progression for GA patients; the potential therapeutic effects,
benefits and dosing schedule of NGM621 and the role of NGM621 as a
potential potent C3 inhibitor engineered with the goal of
inhibiting the central component of the complement cascade by
blocking all of its initiating pathways and that may have the
effect of reducing disease progression in patients with GA; and
other statements that are not historical fact. Because such
statements deal with future events and are based on NGM Bio’s
current expectations, they are subject to various risks and
uncertainties, and actual results, performance or achievements of
NGM Bio 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 and the risk that CATALINA study and
future 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 Bio’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 Bio’s reliance on third-party
manufacturers for NGM621 and its other product candidates; the
sufficiency of NGM Bio’s cash resources and need for additional
capital; and other risks and uncertainties affecting NGM Bio and
its development programs, including those described under the
caption “Risk Factors” in NGM Bio’s quarterly report on Form 10-Q
for the quarter ended September 30, 2021 filed with the United
States Securities and Exchange Commission (SEC) on November 4, 2021
and future filings and reports that NGM Bio makes from time to time
with the SEC. Except as required by law, NGM Bio 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.
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Investor
Contact:Brian Schoelkopfir@ngmbio.com |
Media
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