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
completion of patient enrollment of Part 1 of 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. Preliminary
top-line 12-week data from Part 1 of the AVIATION Trial are
expected in 1Q 2022.
The AVIATION Trial (NCT04897594) is a multi-center, randomized,
double-blind, dose-ranging, placebo-controlled, proof of concept,
adaptive, Phase 1b clinical trial. The trial will 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.
“Completing enrollment of Part 1 of the AVIATION Trial is an
important step towards our goal to bring a safe and effective
medicine to NASH patients,” said Diana Chung, Senior Vice President
of Clinical Development & Operations at Terns. “We are grateful
for the enthusiasm to participate in this trial from study
investigators and patients which allowed us to achieve rapid
enrollment, especially in light of the challenges of the ongoing
COVID-19 pandemic.”
The primary objective of the AVIATION Trial is to evaluate the
safety and tolerability of TERN-201 versus placebo when
administered for 12 weeks in patients with NASH. The clinical trial
will be conducted in two parts: Part 1 of the trial is evaluating 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.
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 seven 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 (MAOs).
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, including in relation to the Phase 1b
AVIATION Trial of TERN-201; 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 AVIATION
Trial; 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 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
Media Jenna UrbanBerry & Company Public
Relationsmedia@ternspharma.com
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