NGM Bio Presents Positive Phase 2b Results from the ALPINE 4 Trial of Aldafermin in Patients with Compensated Cirrhosis (F4) Due to NASH at AASLD The Liver Meeting®
November 13 2023 - 9:45AM
NGM Biopharmaceuticals, Inc. (NGM Bio) (Nasdaq: NGM), a
biotechnology company focused on discovering and developing
transformative therapeutics for patients, today shared positive,
comprehensive results from its Phase 2b ALPINE 4 trial of
aldafermin, an engineered FGF19 analog product candidate, in
patients with compensated cirrhosis (liver fibrosis stage 4 or F4)
due to NASH in an oral plenary presentation at the American
Association for the Study of Liver Diseases (AASLD) The Liver
Meeting®.
The presentation titled “Positive Results from the ALPINE 4
Study: a Randomized, Double-blind, Placebo-controlled, Multicenter,
Phase 2b Trial Evaluating Multiple Doses of the FGF19 Analogue
Aldafermin in Patients with Compensated Cirrhosis Due to
Nonalcoholic Steatohepatitis,” is available to conference attendees
for the duration of AASLD The Liver Meeting and will be archived on
the ‘Publications’ page of NGM Bio’s website here following the
meeting. The ALPINE 4 data shared at AASLD The Liver Meeting follow
positive topline results on the primary endpoint reported by NGM
Bio in May 2023.
Mary E. Rinella, M.D., Professor of Medicine and Director,
Metabolic and Steatotic Liver Disease Program at the University of
Chicago Pritzker School of Medicine, who gave the oral
presentation, commented, “We are pleased to see that the ALPINE 4
study is the first Phase 2b in NASH cirrhosis to reach its primary
endpoint. In addition to demonstrating statistically significant
reductions in ELF score, the trial primary endpoint, aldafermin
also signaled dose-dependent improvements in liver fibrosis and
multiple non-invasive secondary endpoints. Compensated cirrhosis
due to NASH is a notoriously difficult-to-treat disease with no
approved treatment options. It’s very encouraging to see multiple
key clinical measurements moving in the right direction in the
ALPINE 4 study, a promising achievement in the quest to bring
forward safe, effective therapeutics for patients suffering with F4
NASH.”
“We are excited to share the comprehensive positive data set
from the ALPINE 4 study with the hepatology community at AASLD.
It’s gratifying to see the potential impact aldafermin is having on
NASH progression and liver health in patients with F4 NASH. This
Phase 2b data set furthers our belief in aldafermin’s therapeutic
potential,” said Hsiao D. Lieu, M.D., Chief Medical Officer at NGM
Bio.
The ALPINE 4 trial evaluated the efficacy, safety and
tolerability of 1 mg and 3 mg doses of aldafermin compared to
placebo in 160 patients with compensated cirrhosis (F4) due to
NASH. (A 0.3 mg aldafermin cohort was part of the original design
of the trial and enrolled seven patients prior to being
discontinued in favor of enrolling more patients in the 1 mg and 3
mg arms of the trial. Patients in the 0.3 mg arm were primarily
evaluated for safety.) The study showed that the primary endpoint
was achieved; patients treated with aldafermin 3 mg showed a
statistically significant reduction in ELF score compared to the
placebo arm after 48 weeks of treatment. ELF is the first and only
FDA-approved non-invasive test reflecting NASH prognosis. ELF
measures direct markers of liver fibrosis and can be used to
predict liver-related events in patients with NASH and compensated
cirrhosis.
Although ALPINE 4 was not statistically powered for the
secondary endpoint of histological fibrosis improvement of ≥
1-stage (NASH Clinical Research Network, or CRN, criteria), a
dose-dependent trend in fibrosis improvement was observed.
Aldafermin demonstrated significant, dose-dependent improvements
across all of the study’s non-invasive secondary endpoints,
including neoepitope-specific N-terminal propeptide of type III
collagen (Pro-C3), alanine aminotransferase (ALT), aspartate
aminotransferase (AST), 7alpha-hydroxy-4-cholesten-3-one (C4), bile
acids and liver stiffness measurement (LSM) by FibroScan® at week
48. These non-invasive tests are correlated with liver
fibrogenesis, liver inflammation and injury, and NASH
progression.
Aldafermin was generally well tolerated in the ALPINE 4 study
with no treatment-related serious adverse events and a safety and
tolerability profile generally consistent with prior trials of
aldafermin, including higher levels of gastrointestinal events in
patients treated with aldafermin as compared to patients treated
with placebo. Aldafermin-associated increase in low-density
lipoprotein cholesterol, consistent with on-target inhibition of
bile acid synthesis, was mitigated by co-administration of
rosuvastatin. There was no observed signal for adverse
cardiovascular events in this trial related to aldafermin.
A manuscript on the ALPINE 4 study has been accepted and
published online ahead-of-print in Hepatology (Hepatology 2023;
doi: 10.1097/HEP.0000000000000607).
About NGM BioNGM 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.
Visit us at www.ngmbio.com for more information.
FibroScan® is a registered trademark of Echosens SA.
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
“will,” “may,” “potential,” “belief,” “promising,” “compelling,”
“aspires,” “aims” 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: the therapeutic
potential of NGM Bio’s product candidates, including aldafermin;
NGM Bio’s continued pipeline development, including any potential
further development of aldafermin, and research and development and
discovery engine output; the potential for aldafermin to treat
patients with F4 NASH; 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 aldafermin may not prove
to be safe, well-tolerated or effective; 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; NGM Bio’s
ability to identify and engage third-party partners for potential
future business development arrangements, if any, and its ability
to attract such partners; 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 expected cash runway, including the
risk that NGM Bio could utilize its available capital resources
sooner than it currently expects and its need for additional
capital; macroeconomic conditions (such as the impacts of the
ongoing COVID-19 pandemic and global geopolitical conflicts, global
economic slowdown, increased inflation, rising interest rates and
recent and potential future bank failures); 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
September 30, 2023 filed with the United States Securities and
Exchange Commission (“SEC”) on November 2, 2023 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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Media Contact:media@ngmbio.com |
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