Terns Pharmaceuticals, Inc. (“Terns” or the “Company”) (Nasdaq:
TERN), a clinical-stage biopharmaceutical company developing a
portfolio of small-molecule single-agent and combination therapy
candidates for the treatment of non-alcoholic steatohepatitis
(NASH) and other chronic liver diseases, today announced that three
abstracts detailing clinical data for multiple non-alcoholic
steatohepatitis (NASH) programs within the Company's portfolio were
accepted for presentation at The Liver Meeting® Digital Experience
2021, the annual meeting of the American Association for the Study
of Liver Diseases (AASLD), which will be held virtually from
November 12-15, 2021. The oral and poster abstracts were published
in the October supplement of Hepatology, the peer-reviewed journal
of AASLD.
Details of the presentations at The Liver Meeting are as
follows:
Oral Presentation
Title: Liver-distributed FXR Agonist TERN-101
Demonstrates Favorable Safety and Efficacy Profile in NASH Phase 2a
LIFT StudyPublication Number: 143Session
Title: Parallel 21: NAFLD and NASH: Clinical Trials of
Novel TherapeuticsPresenting Author: Rohit
LoombaDate and Time: Sunday, November 14, 6:30
p.m. ET
Poster Presentations
Title: Single Doses of the THR-β Agonist
TERN-501 are Well Tolerated and Result in Dose-dependent Changes in
LDL Cholesterol and Sex Hormone Binding Globulin in a
First-in-Human Clinical TrialPresentation Number:
1889Session Title: NAFLD and NASH: Experimental:
ClinicalPresenting Author: D. Barry Crittenden
Title: Liver-distributed FXR Agonist TERN-101
Leads to Corrected T1 (cT1) Response and a Population Shift to
Lower cT1 Risk Categories in NASH Phase 2a LIFT
StudyPublication Number: 1875Session
Title: NAFLD and NASH: Experimental:
ClinicalPresenting Author: Eric Lawitz
About TERN-101TERN-101 is a liver-distributed,
non-bile acid FXR agonist that has demonstrated a differentiated
tolerability profile and improved target engagement, likely due to
its sustained FXR activation in the liver but only transient FXR
activation in the intestine. FXR is a nuclear receptor primarily
expressed in the liver, intestine and kidneys. FXR regulates
hepatic expression of various genes involved in lipid metabolism,
inflammation and fibrosis. Clinical studies of other FXR agonists
have demonstrated significant histological NASH improvements but
have also resulted in pruritus, adverse lipid changes and
discontinuations. Terns reported positive top-line results from the
Phase 2a LIFT Study of TERN-101 in June 2021.
About TERN-501TERN-501 is a thyroid hormone
receptor beta (THR-β) agonist with high metabolic stability,
enhanced liver distribution and greater selectivity for THR-β
compared to other THR-β agonists in development. Agonism of THR-β
increases fatty acid metabolism via mitochondrial oxidation and
affects cholesterol synthesis and metabolism. As a result, THR-β
stimulation has the ability to reduce hepatic steatosis and improve
serum lipid parameters including LDL cholesterol and triglycerides.
In vivo NASH studies in a rodent model have demonstrated that
low-doses of TERN-501 achieved complete resolution of steatosis and
reductions in serum lipids, hepatic inflammation and fibrosis.
TERN-501 has high liver distribution and is 23-fold more selective
for THR-β than for THR-α activation in a cell free assay, thereby
minimizing the risk of cardiotoxicity and other off-target effects
associated with non-selective THR stimulation. Finally, TERN-501
has been designed to be metabolically stable and is therefore
expected to have little pharmacokinetic variability and a low
clinical dose, making it an attractive candidate for use in
fixed-dose combinations for NASH treatment.
About Terns PharmaceuticalsTerns
Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company
developing a portfolio of small-molecule single-agent and
combination therapy candidates for the treatment of non-alcoholic
steatohepatitis, or NASH, and other chronic liver diseases. Terns’
pipeline includes three clinical stage development programs
including an FXR agonist, a VAP-1 inhibitor and a THR-β agonist,
and a preclinical GLP-1 receptor agonist program. Terns is focused
on developing combination therapies based on clinically validated
and complementary mechanisms of action to address the multiple
hepatic disease processes of NASH in order to drive meaningful
clinical benefits for patients. For more information, please visit:
www.ternspharma.com.
Cautionary Note Regarding Forward-Looking
StatementsThis press release contains forward-looking
statements about Terns Pharmaceuticals, Inc. (the “Company,” “we,”
“us,” or “our”) within the meaning of the federal securities laws,
including those related to the Company’s expectations of timing and
potential results of the Company’s clinical trials and other
development activities and the potential utility and progress of
the Company’s product candidates in NASH. All statements other than
statements of historical facts contained in this press release,
including statements regarding the Company’s strategy, future
financial condition, future operations, projected costs, prospects,
plans, objectives of management and expected market growth, are
forward-looking statements. In some cases, you can identify
forward-looking statements by terminology such as “aim,”
“anticipate,” “assume,” “believe,” “contemplate,” “continue,”
“could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,”
“may,” “objective,” “plan,” “positioned,” “potential,” “predict,”
“seek,” “should,” “target,” “will,” “would” and other similar
expressions that are predictions of or indicate future events and
future trends, or the negative of these terms or other comparable
terminology. The Company has based these forward-looking statements
largely on its current expectations, estimates, forecasts and
projections about future events and financial trends that it
believes may affect its financial condition, results of operations,
business strategy and financial needs. In light of the significant
uncertainties in these forward-looking statements, you should not
rely upon forward-looking statements as predictions of future
events. These statements are subject to risks and uncertainties
that could cause the actual results and the implementation of the
Company’s plans to vary materially, including the risks associated
with the initiation, cost, timing, progress and results of the
Company’s current and future research and development activities
and preclinical studies and clinical trials. In particular, the
impact of the COVID-19 pandemic on the Company’s ability to
progress with its research, development, manufacturing and
regulatory efforts, including the Company’s clinical trials for its
product candidates, will depend on future developments that are
highly uncertain and cannot be predicted with confidence at this
time, such as the ultimate duration of the pandemic, travel
restrictions, quarantines, social distancing and business closure
requirements in the United States and in other countries, and the
effectiveness of actions taken globally to contain and treat the
disease. These risks are not exhaustive. For a detailed discussion
of the risk factors that could affect the Company’s actual results,
please refer to the risk factors identified in the Company’s SEC
reports, including but not limited to its Annual Report on Form
10-K for the year ended December 31, 2020 and its Quarterly Reports
on Form 10-Q for the periods ended March 31, 2021 and June 30,
2021. Except as required by law, the Company undertakes no
obligation to update publicly any forward-looking statements for
any reason.
Contacts for Terns
InvestorsJustin Nginvestors@ternspharma.com
MediaJenna UrbanBerry & Company Public
Relationsmedia@ternspharma.com
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