Terns Pharmaceuticals, Inc. (“Terns” or the “Company”) (Nasdaq:
TERN), a clinical-stage biopharmaceutical company developing a
portfolio of small-molecule product candidates to address serious
diseases, including oncology, obesity and non-alcoholic
steatohepatitis (NASH), today announced that the first participant
has been dosed in the Phase 1 clinical trial of TERN-601, the
Company’s oral small-molecule glucagon-like peptide-1 receptor, or
GLP-1R, agonist for the treatment of obesity.
“We are excited to initiate this first-in-human study of our
oral GLP-1R agonist, TERN-601, as we believe it represents a
potentially meaningful alternative to the currently marketed
injectable GLP-1R agonist treatments,” said Erin Quirk, MD,
president and head of research and development at Terns. “TERN-601
represents our first internally discovered small molecule GLP-1R
agonist, which is designed to be administered orally once daily
with a competitive profile for weight loss, both as a monotherapy
and as part of a potential all oral combination treatment for
obesity.”
“We are encouraged by the prospects for our obesity franchise
and look forward to reporting initial 28-day weight loss proof of
concept data from the Phase 1 trial of TERN-601, which is
anticipated in the second half of 2024. We also have ongoing
discovery efforts in obesity with our TERN-600 series of additional
small molecule GLP-1R agonists and our TERN-800 series of
small-molecule glucose-dependent insulinotropic polypeptide
receptor (GIPR) modulators, which have the potential to be combined
with GLP-1R agonists. These programs along with TERN-501, our
highly selective THR-β agonist in development for the treatment of
NASH, aim to meaningfully improve clinical outcomes for patients
battling metabolic diseases, with better potential tolerability,
accessibility and ease-of-use than currently available treatments,”
added Dr. Quirk.
Phase 1 Trial DesignThe Phase 1 trial is a
randomized, double-blind, placebo-controlled single and
multiple-ascending dose (SAD and MAD) trial to assess the safety,
tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of
TERN-601 in healthy adults with obesity or overweight. The trial
will consist of two parts.
Part 1 (SAD) is a single ascending dose study that will evaluate
up to six once-daily TERN-601 dose levels in approximately 40
healthy participants with a Body Mass Index (BMI) of ≥ 25 kg/m2 and
< 40 kg/m2. The starting TERN-601 dose is 30 mg, with subsequent
dose levels based on review of emerging safety and PK data from
prior cohorts.
In Part 2 (MAD) of the trial, obese and overweight healthy
adults will be enrolled in cohorts that will include titration of
TERN-601 administered for 28-days at doses to be selected based on
data from Part 1 (SAD). Part 2 will include approximately 72
healthy participants with a BMI of ≥ 27 kg/m2 to < 40 kg/m2. The
primary endpoint of the trial is safety and tolerability. Secondary
endpoints include PK, efficacy as measured by body weight loss
following 28-days of treatment with TERN-601, and other exploratory
markers. Top-line, proof of concept 28-day weight loss data from
Part 2 (MAD) are expected in the second half of 2024.
About TERN-601TERN-601 is an oral,
small-molecule glucagon-like peptide-1 receptor, or GLP-1R, agonist
program for obesity. Obesity is a chronic disease that is
increasing in prevalence in adults, adolescents and children and is
often defined by having an elevated BMI of 30 or greater. GLP-1
agonism offers multiple benefits including improved glucose
control, slowing of gastric emptying and increases in satiety.
Terns’ lead GLP-1R agonist, TERN-601, was designed through internal
structure-based drug discovery efforts employing our proprietary
three-dimensional QSAR model of the receptor, which was used to
identify new GLP-1R agonist candidates. The ligands were further
optimized based on in vitro activity, metabolic stability, and
pharmacokinetic parameters. Through this process, we discovered
TERN-601, a potent GLP-1R agonist biased towards cAMP generation. A
Phase 1, first-in-human clinical trial for obesity is underway with
top-line data expected in the second half of 2024. TERN-601’s
potential as a treatment for obesity is supported by preclinical
data that were presented at the American Diabetes Association’s
83rd Annual Scientific Session in June 2023. The full poster is
available on Terns’ scientific publications website.
About Terns PharmaceuticalsTerns
Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company
developing a portfolio of small-molecule product candidates to
address serious diseases, including oncology, obesity and NASH.
Terns’ pipeline includes three clinical stage development programs
including an allosteric BCR-ABL inhibitor, a small-molecule GLP-1
receptor agonist, a THR-β agonist and a preclinical GIPR modulator
program. For more information, please visit:
www.ternspharma.com.
Cautionary Note Regarding Forward-Looking
Statements This 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 clinical trials and other development
activities of the Company and its partners; the potential
indications to be targeted by the Company with its small-molecule
product candidates; the therapeutic potential of the Company’s
small-molecule product candidates; the potential for the mechanisms
of action of the Company’s product candidates to be therapeutic
targets for their targeted indications; the potential utility and
progress of the Company’s product candidates in their targeted
indications, including the clinical utility of the data from and
the endpoints used in the Company’s clinical trials; the Company’s
clinical development plans and activities; the Company’s
expectations regarding the profile of its product candidates,
including efficacy, tolerability, safety, metabolic stability and
pharmacokinetic profile and potential differentiation as compared
to other products or product candidates; the Company’s plans for
and ability to continue to execute on its current development
strategy, including potential combinations involving multiple
product candidates; and the Company’s expectations with regard to
the sufficiency of its financial resources. 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, results and utility of the
Company’s current and future research and development activities
and preclinical studies and clinical trials. 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, 2022. 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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