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 to address serious diseases such as non-alcoholic
steatohepatitis (NASH) and obesity, today reported top-line results
from Part 1 of the Company’s Phase 1b AVIATION Trial of TERN-201, a
vascular adhesion protein-1 (VAP-1) inhibitor in development for
the treatment of patients with NASH.
Part 1 of the AVIATION Trial met the primary safety
endpoint. Compared to placebo, TERN-201 10 mg administered for 12
weeks to presumed NASH patients was generally well-tolerated with a
similar incidence of adverse events (AEs) between the 10 mg
treatment group and placebo. All AEs were mild to moderate. There
were no treatment-emergent serious AEs (SAEs), including no cases
of treatment-related monoamine oxidase inhibition (e.g., central
nervous system toxicity), and no patients discontinued TERN-201 or
the study due to any AE. While treatment with TERN-201 10 mg
resulted in near complete (>98%) inhibition of plasma VAP-1 in
most subjects, there were no meaningful changes in exploratory
serum or imaging NASH biomarkers with TERN-201 10 mg relative to
placebo, including corrected T1 (cT1), a measure of inflammation
and fibrosis linked to clinical outcomes, as well as ALT, AST, GGT
and CK-18.
Part 2 of the AVIATION Trial assessing 20 mg of
TERN-201 remains ongoing, with top-line results expected in the
second half of 2022. Terns will continue to analyze results from
Part 1 of the AVIATION Trial to evaluate next steps for the
TERN-201 program.
“We want to thank the patients, study teams and
physicians who participated in the well-executed Part 1 of the
AVIATION Trial,” said Erin Quirk, M.D., President, Chief Medical
Officer and Head of R&D at Terns. “While the AVIATION results
from Part 1 were disappointing, Terns is fortunate to have a broad
pipeline, cash runway expected to fund operations into 2024 and a
stellar team to support our pipeline activities. We look forward to
the planned initiation of our Phase 2a trial of TERN-501 alone and
in combination with TERN-101 for NASH in the first half of 2022 and
our Phase 1 trial of TERN-601, an oral small-molecule GLP-1
receptor agonist for obesity, in 2023.”
About the AVIATION TrialThe
AVIATION Trial (NCT04897594) is a multi-center, randomized,
double-blind, dose-ranging, placebo-controlled, proof of concept,
adaptive, Phase 1b clinical trial. The primary objective of the
AVIATION trial is to evaluate the safety and tolerability of
TERN-201 over 12 weeks of treatment in patients with presumed
non-cirrhotic NASH. Secondary objectives included pharmacokinetics
and assessment of pharmacodynamic effect on VAP-1 activity. The
clinical trial is designed to be conducted in two parts (Part 1 and
Part 2). Part 1 of the AVIATION Trial evaluated 10 mg TERN-201 over
12 weeks with a four-week follow-up period. The patients in Part 1
were randomized to receive placebo (n=10) or 10 mg TERN-201 (n=20),
and patients in Part 2 are randomized to receive placebo or 20 mg
TERN-201.
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). Terns received Fast Track Designation
from the FDA for TERN-201 for the treatment of NASH in August 2020.
TERN-201 was in-licensed from Eli Lilly and Company in March 2018
pursuant to an exclusive, worldwide license agreement.
About Terns PharmaceuticalsTerns
Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company
developing a portfolio of small-molecule single-agent and
combination therapy candidates to address serious diseases such as
NASH and obesity. Terns’ pipeline includes three clinical stage
development programs including an FXR agonist, a VAP-1 inhibitor
and a THR-β agonist, and a preclinical small-molecule GLP-1
receptor agonist program. 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 ongoing 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 its plans for Part 2 of the AVIATION Trial
and further development of TERN-201 in NASH; the Company’s
expectations regarding the profile of its product candidates,
including tolerability, safety, metabolic stability and
pharmacokinetic profile; the Company’s anticipated cash runway; 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, 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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