NGM Biopharmaceuticals, Inc. (NGM Bio) (Nasdaq: NGM), a
biotechnology company focused on discovering and developing
transformative therapeutics for patients, today announced topline
efficacy and safety results from its randomized, double-masked,
sham-controlled CATALINA Phase 2 trial of NGM621 in patients with
geographic atrophy (GA) secondary to age-related macular
degeneration (AMD). NGM621 is a humanized immunoglobulin G1 (IgG1)
monoclonal antibody designed to inhibit activity of complement
component 3 (C3). Over 52 weeks of treatment, NGM621 administered
every four weeks (Q4W) (n=108) and every eight weeks (Q8W) (n=104)
via intravitreal injection demonstrated a reduction in the rate of
change in GA lesion area (slope) of 6.3% and 6.5%, respectively,
compared to sham (n=106), which did not reach statistical
significance in either arm. NGM621 demonstrated a favorable safety
profile, with no evidence of increased choroidal neovascularization
(CNV) conversions and numerically fewer cases of CNV in
NGM621-treated patients compared to sham. In addition, there were
no drug-related serious adverse events (SAEs).
“We’re disappointed that the CATALINA study did not meet its
primary endpoint, particularly given the significant unmet medical
need of patients impacted by GA,” said David J. Woodhouse, Ph.D.,
Chief Executive Officer at NGM Bio. “We continue to evaluate
various pre-specified secondary endpoints and post-hoc analyses. We
expect these additional findings, as well as the absence of
treatment-related CNV conversion and the overall clean safety
profile NGM621 showed in CATALINA, to provide important information
regarding the treatment of patients with GA.”
“Through data from CATALINA, I believe we can gain insights not
only related to NGM621, but also importantly into strategies to
optimize clinical development programs for the GA field more
broadly. As we have seen repeatedly, there can be high variability
in outcomes among trials of complement inhibitors for GA, and we
are still learning how such variability impacts the evaluation of
therapeutics for this devastating disease process,” said Charles C.
Wykoff, M.D., Ph.D., Director of Research at Retina Consultants
Texas and an investigator for the CATALINA study. “While the
CATALINA trial did not meet its primary endpoint, the notable CNV
finding combined with signals from secondary and exploratory
analyses suggest the possibility that NGM621 may have a role in
treating GA. I look forward to evaluating further details from this
trial and presenting the findings at the upcoming Retina Society
Annual Meeting in November.”
CATALINA Phase 2 Study Safety Findings
NGM621 demonstrated a favorable safety and tolerability profile,
with no evidence of increased treatment-related CNV conversions
compared to sham and numerically fewer cases of CNV in
NGM621-treated patients compared to sham. There were also no cases
of endophthalmitis (infection of the eye) or optic ischemic
neuropathy, a low overall rate of inflammation and, overall, no
treatment-related SAEs. The most frequently reported ocular adverse
events were those most likely to be attributed to the intravitreal
injection procedure or to GA worsening.
“On behalf of the entire NGM Bio team, I’d like to thank the
investigators and clinical trial staff involved in this study, our
employees who contributed to this tremendous effort and, most
importantly, the patients who participated in the study to help
advance our understanding of NGM621 as a potential treatment for
GA. We recognize the significant unmet need of GA patients for
effective treatment solutions, and we remain hopeful that NGM621
may have the potential to demonstrate future clinical benefit,”
said Hsiao D. Lieu, M.D., Chief Medical Officer at NGM Bio.
Conference Call / Webcast Details
NGM Bio will host a conference call and webcast with slide
presentation at 8:00 a.m. ET (5:00 a.m. PT) today. To access the
live webcast and slides, please visit the “Investors & Media”
section of NGM Bio’s website at https://ir.ngmbio.com/. The
webcast will be archived for 30 days.
NGM621 CATALINA Phase 2 Study Design
The Phase 2 CATALINA study enrolled 320 patients diagnosed with
GA secondary to AMD in one or both eyes. The primary objectives of
this multicenter, randomized, double-masked, sham-controlled study
were to evaluate the efficacy and safety of NGM621 when given every
four weeks or every eight weeks via intravitreal injections
compared to sham injection control. Patients were randomized to one
of four treatment groups in a ratio of 2:1:2:1 to receive
intravitreal injections of NGM621 or sham injections every four
weeks or every eight weeks for a total of 52 weeks with a final
follow-up visit at 56 weeks. The primary efficacy endpoint was the
rate of change in GA lesion area (slope), as measured by fundus
autofluorescence imaging, over 52 weeks of treatment. The primary
safety endpoints evaluated the incidence and severity of ocular and
systemic adverse events from treatment with NGM621 compared to sham
control.
Merck NGM621 Licensing Option
NGM621 falls within the scope of NGM Bio’s collaboration with
Merck. Under the terms of the collaboration, following the CATALINA
Phase 2 proof-of-concept trial, Merck has a one-time option to a
worldwide, exclusive license for NGM621 and its related compounds,
either alone or bundled with two additional undisclosed
pre-clinical ophthalmology compounds and their related compounds.
Merck is required to make its option decision in approximately
three months. If Merck does not exercise its one-time option for
NGM621, then NGM Bio will retain worldwide rights to NGM621, with a
low, single digit royalty obligation to Merck if NGM Bio or a
partner commercializes the program.
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 NGM Bio
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,
always led by biology and motivated by unmet patient need. Today,
the company has seven programs in clinical
development, including four in Phase 2 or 2b
studies, including the recently completed NGM621 CATALINA
trial, across three therapeutic areas:
cancer, retinal diseases and liver and
metabolic diseases. 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 “will,” ”may,” “potential,” “potentially,”
“hopeful,” “future,” “look forward,” “continue,” “promising,”
“possibility,” ”aspires,” “aims”, “expect” 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 expectation that additional findings, as well as the
absence of treatment-related CNV conversion and the overall clean
safety profile NGM621 showed in CATALINA, will provide important
information regarding the treatment of patients with GA; the
possibility that NGM621 may have a role in treating GA; the
potential of NGM621 to demonstrate future clinical benefit; Merck’s
decision, or not, to exercise a one-time option to a worldwide,
exclusive license for NGM621 and its related compounds, either
alone or bundled with two additional undisclosed pre-clinical
ophthalmology compounds and their related compounds and the timing
of any such decision by Merck; NGM Bio’s aspiration to operate one
of the most productive research and development engines in the
biopharmaceutical industry; 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 statements in this press release.
These forward-looking statements are subject to risks and
uncertainties, including, without limitation, risks and
uncertainties associated with the costly and time-consuming
pharmaceutical product development process and the uncertainty of
clinical success, including the risk that NGM621 may be unable to
demonstrate future clinical benefit in patients with GA,
particularly in light of the failure to achieve the primary
endpoint in the Phase 2 CATALINA study of NGM621; risks related to
failure or delays in successfully initiating, enrolling, reporting
data from or completing clinical studies, as well as the risks that
results obtained in preclinical or clinical trials to date may not
be indicative of results obtained in future trials and that
post-hoc analyses performed after unmasking trial results can
result in the introduction of bias, have other limitations and may
not be predictive of results obtained in future trials; NGM Bio’s
reliance on its amended collaboration with Merck, including the
risks that if Merck fails to exercise its option to license NGM621,
NGM Bio would need to partner the NGM621 program and/or raise
substantial additional capital in order to further clinical
development of NGM621, if any, which NGM Bio may be unable to do in
a timely manner or at all, which could delay or preclude the
further development of and/or commercialization of NGM621; the
ongoing COVID-19 pandemic, which has adversely affected, and could
materially and adversely affect in the future, NGM Bio’s business
and operations, including NGM Bio’s ability to timely supply,
initiate, enroll and complete its ongoing and future clinical
trials; the time-consuming and uncertain regulatory approval
process; NGM Bio’s reliance on third-party manufacturers for its
product candidates and the risks inherent in manufacturing and
testing pharmaceutical products; the sufficiency of NGM Bio’s cash
resources and NGM Bio’s need for additional capital; and other
risks and uncertainties affecting NGM Bio and its development
programs, including those discussed in the section titled “Risk
Factors” in NGM Bio’s quarterly report on Form 10-Q for the quarter
ended June 30, 2022 filed with the Securities and Exchange
Commission (SEC) on August 4, 2022 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.
Investor Contact:Brian
Schoelkopfir@ngmbio.com |
Media
Contact:Liz Melonelmelone@ngmbio.com |
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