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), obesity and cancer, today announced that
results from clinical trials of TERN-501, TERN-101 and TERN-201
will be highlighted in several presentations at the European
Association for the Study of the Liver (EASL) International Liver
Congress™ (ILC) 2022, taking place June 22-26 in London, United
Kingdom. The Company’s presentations will include four posters and
one oral presentation.
The oral presentation titled “Multiple doses of thyroid hormone
receptor-beta agonist TERN-501 were well-tolerated and resulted in
significant dose-dependent changes in serum lipids and sex hormone
binding globulin in a first-in-human clinical study,” will be
delivered by Cara Nelson, Ph.D., senior director of clinical
pharmacology at Terns, on Saturday, June 25 at 6:15 p.m. BT. This
presentation will highlight results from the multiple ascending
dose (MAD) cohort of the Phase 1 clinical trial of TERN-501 in
healthy volunteers with mildly elevated low-density lipoprotein
cholesterol (LDL-c). 3, 6 and 10 mg of TERN-501 administered for 14
days was overall safe and well-tolerated with no study drug
discontinuations and significant, dose-dependent increases in sex
hormone binding globulin, a marker of THR-β target engagement in
the liver that has been associated with liver fat content
reductions and histopathologic improvements in THR-β treated NASH
patients. This study supports further investigation of TERN-501 for
NASH treatment alone or in combination with other agents.
“As we continue to build momentum across our diverse pipeline,
it is encouraging to see the growing body of late-stage clinical
evidence supporting the THR-β class, including our candidate
TERN-501, as a potential treatment for NASH. We are particularly
excited to have initiated the first-ever combination NASH trial of
a THR-β agonist alone and in combination with our FXR agonist, with
top-line data expected in the second half of 2023,” said Erin
Quirk, M.D., president and head of research & development at
Terns.
Data are also being presented from the Phase 2a LIFT study of
TERN-101, the Company’s liver-distributed farnesoid X receptor
(FXR) agonist. LIFT was a multicenter, randomized, double-blind,
placebo-controlled study evaluating 5, 10 and 15 mg doses of
TERN-101 in 100 adult patients with non-cirrhotic NASH for 12
weeks. Terns reported positive top-line results from the LIFT study
in June 2021. LIFT was the first 12-week controlled trial in NASH
to show significant improvements in cT1, a marker of
fibro-inflammation linked to clinical outcomes, and the first FXR
agonist trial to demonstrate no discontinuations due to adverse
events (AEs), including pruritus. Presentations at ILC 2022
highlight additional details on safety data for TERN-101 including
lipid, pruritus and COVID-19 profiles, as well as pharmacokinetic
(PK) and pharmacodynamic (PD) results.
A second clinical presentation titled “Favorable lipid and
pruritus profile of liver-distributed farnesoid X receptor agonist
TERN-101 at clinically efficacious doses in non-alcoholic
steatohepatitis phase 2a LIFT study” will be delivered by Kris
Kowdley, M.D., Director of Liver Institute Northwest. This
presentation will detail the favorable LDL-c, high-density
lipoprotein cholesterol (HDL-c) and pruritus profiles observed
during the trial.
A third clinical presentation titled “Liver-distributed
farnesoid X receptor agonist TERN-101 demonstrates potent target
engagement with a favorable exposure-response profile in
non-alcoholic steatohepatitis patients” will be delivered by Cara
Nelson. This presentation will detail additional PK, PD target
engagement biomarkers and favorable exposure-response relationships
from the LIFT trial.
A fourth clinical presentation titled “TERN-101, a farnesoid X
receptor agonist, demonstrated similar safety and efficacy in
non-alcoholic steatohepatitis patients with coronavirus disease of
2019 (COVID-19) exposure compared to those with no COVID-19
exposure in phase 2a LIFT study” will be presented by Kris Kowdley.
Data from the LIFT study, which was conducted during the COVID-19
pandemic, showed that the TERN-101 safety profile and cT1 responses
were similar between the subset of patients with COVID-19 exposure
and those without.
Terns is also presenting additional results from Part 1 of the
Phase 1b AVIATION Trial of TERN-201 in patients with NASH. In a
fifth clinical presentation titled “Favorable safety profile of
TERN-201, a highly selective inhibitor of vascular adhesion
protein-1, in the non-alcoholic steatohepatitis phase 1b AVIATION
study” to be presented by Mazen Noureddin, M.D., M.H.Sc., Director
of Fatty Liver Program at Cedars-Sinai Medical Center, findings
showed that TERN-201 was well-tolerated with a safety profile
similar to placebo.
A full list of ILC 2022 presentation abstracts can be found in
the July supplement of the Journal of Hepatology.
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, obesity and cancer. Terns’ pipeline includes four clinical
stage development programs including a THR-β agonist, an allosteric
BCR-ABL inhibitor, an FXR agonist, a VAP-1 inhibitor, 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, such as the Phase 2a combination trial of
TERN-501 and TERN-101; the potential indications to be targeted by
the Company with its single-agent and combination therapy
candidates; the therapeutic potential of the Company’s single-agent
and combination therapy 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 tolerability, safety, metabolic stability and
pharmacokinetic profile and potential differentiation as compared
to other products or product candidates; and the Company’s plans
for and ability to continue to execute on its current clinical
strategy. 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. 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 and its Quarterly Report
on Form 10-Q for the period ended March 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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