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 the
initiation of patient dosing in the AVIATION Trial, a Phase 1b
clinical trial evaluating TERN-201, an orally-administered, highly
selective inhibitor of vascular adhesion protein-1 (VAP-1) in
patients with NASH.
The AVIATION Trial (NCT04897594) is a multi-center, randomized,
double-blind, dose-ranging, placebo-controlled, proof of concept,
adaptive, Phase 1b clinical trial to evaluate the safety,
pharmacokinetics, pharmacodynamics, and efficacy of TERN-201 in
patients with presumed non-cirrhotic NASH and a cT1 value of
greater than 800ms. Corrected T1, or cT1, is a magnetic
resonance-based imaging test measuring liver inflammation and
fibrosis that has been associated with clinical outcomes and liver
histology. The primary objective of the AVIATION Trial is to
evaluate the safety and tolerability of TERN-201 versus placebo
when given for 12 weeks in patients with NASH. The clinical trial
will be conducted in two parts: Part 1 of the trial has begun with
a dose of 10 mg as compared to placebo while Part 2 is expected to
enroll additional dose cohorts of TERN-201 based on an interim
assessment of the 10 mg cohort. Each part of the AVIATION Trial is
planned to include approximately 20 patients receiving each of the
designated doses of TERN-201 and approximately 10 patients
receiving placebo. The clinical trial will also explore the effects
of TERN-201 on NASH imaging biomarkers (such as cT1) and NASH blood
biomarkers (such as CK-18). Preliminary topline 12-week data from
Part 1 and Part 2 of the AVIATION Trial are expected in 1H 2022 and
2H 2022, respectively.
“Increasing evidence points to the role of VAP-1 in
recruiting white blood cells to the liver as a key
factor driving liver inflammation and fibrosis in people
living with NASH,” said Erin Quirk, M.D., President, Chief
Medical Officer and Head of R&D at Terns, “We
are excited
by TERN-201’s selective VAP-1 inhibition and
its potential anti-inflammatory and anti-fibrotic
effects which
may complement the anti-steatotic activity
seen with our other product candidates. Initiation of the
AVIATION Trial is an important step towards a single
once-daily pill as an effective NASH treatment.”
About TERN-201TERN-201 is a highly selective,
irreversible, covalent inhibitor of vascular adhesion protein-1
(VAP-1). VAP-1 is a transmembrane protein highly expressed in
hepatic vascular endothelial cells that binds to proteins on the
surface of white blood cells to facilitate their deceleration,
binding and transmigration from the blood stream into the liver.
VAP-1 has been shown to be over-expressed in the livers of patients
with NASH and fibrosis. In Terns’ Phase 1 first-in-human (SAD/MAD)
clinical trial across 61 healthy subjects, TERN-201 was shown to be
well-tolerated and fully suppress the enzymatic activity of VAP-1
at all evaluated doses with suppression persisting up to 7 days
after a single dose. In preclinical studies, TERN-201 showed
significant dose-dependent reductions in liver inflammation and
fibrosis in a model of liver injury. TERN-201 exhibits high
selectivity for VAP-1, enhanced liver distribution and minimal
potential for off-target inhibition of monoamine oxidases (MAO).
The sustained activity of TERN-201, with its VAP-1 selectivity and
anticipated low therapeutic dose, may make it suitable for
co-administration with therapies directed at steatosis and other
metabolic processes involved in NASH. Terns received Fast Track
Designation from the FDA for TERN-201 for the treatment of NASH in
August 2020.
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; the therapeutic potential of TERN-201; the
potential for vascular adhesion protein-1 (VAP-1) to be a
therapeutic target for NASH; the potential utility and progress of
the Company’s product candidates in NASH, including the clinical
utility of the data from and the endpoints used in the Phase 1b
AVIATION Trial of TERN-201; the Company’s clinical development
plans and activities, including the development plans for TERN-201
in combination with therapies directed at steatosis and other
metabolic processes involved in NASH; the Company’s expectations
regarding the profile of its product candidates, including
tolerability, safety, metabolic stability and pharmacokinetic
profile; and the Company’s ability to continue to execute on its
clinical strategy and plans. 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, future trial results, 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 Report on form 10-Q for the three months ended March 31,
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
Media Jenna UrbanBerry & Company Public
Relationsmedia@ternspharma.com
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