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 the late-breaking oral
presentation of top-line data from its Phase 2a DUET clinical trial
of TERN-501, an investigational orally administered thyroid hormone
receptor-β (THR-β) agonist for the treatment of NASH. TERN-501 was
evaluated alone and in combination with the Company’s
liver-distributed farnesoid X receptor (FXR) agonist TERN-101.
These data will be presented at The Liver Meeting®, the annual
meeting of the American Association for the Study of Liver Diseases
(AASLD), on Monday, November 13 at 2:00 p.m. ET in Boston,
Massachusetts.
“NASH continues to be a serious, multi-faceted disease, and it
is encouraging to see the additional evidence supporting the THR-β
mechanism of action of TERN-501 to address these disease
processes,” said Mazen Noureddin, M.D., MHSc, Professor of
Medicine, Academic Institute, Houston Methodist, Director of
Houston Research Institute, study presenter and principal
investigator in the DUET trial. “The efficacy of TERN-501, showing
a significant impact on steatosis and fibro-inflammation markers in
a short period of time, coupled with its convenient oral once-daily
dosing and highly positive safety profile, indicate that TERN-501
is a promising candidate for NASH treatment, either as a
monotherapy or in combination with other therapies.”
Late-Breaking Oral
Presentation |
Date/Time: |
|
November 13,
2023 at 2:00 p.m. ET |
Location: |
|
Auditorium |
Session Title: |
|
Late Breaking Abstract #1 |
|
|
|
In the Phase 2a DUET trial, patients with phenotypic or prior
histologic NASH were randomized to one of seven treatments:
once-daily, orally administered TERN-501 (1, 3 or 6 mg), TERN-101
(10 mg), TERN-501 (3 or 6 mg) combined with TERN-101 (10 mg), or
placebo. The primary endpoint was the relative change from baseline
in magnetic resonance imaging proton density fat fraction
(MRI-PDFF), a measure of liver fat content, at Week 12 for TERN-501
monotherapy versus placebo. The study also assessed liver
fibro-inflammation as measured by MRI corrected T1 (cT1), sex
hormone binding globulin (SHBG) levels, a marker of THR-β agonism
in the liver, lipid levels, and other fibrosis biomarkers as well
as safety and tolerability following treatment.
Late-Breaking Phase 2a DUET Top-line Data to be
Presented at AASLD The Liver Meeting
- TERN-501 (6 mg) monotherapy demonstrated significant reductions
in liver fat content as early as Week 6
- The study met its primary endpoint, with TERN-501 monotherapy
demonstrating a mean relative reduction of 27% (p=0.0036) and 45%
(p<0.0001) at 3 mg and 6 mg doses, respectively, versus a 4%
reduction in the placebo group at Week 12
- A significantly higher percentage of patients achieved a ≥30%
MRI-PDFF reduction in TERN-501 arms and a ≥50% reduction with
TERN-501 (6 mg) monotherapy at Week 12
- TERN-501 (6 mg) monotherapy resulted in a significant and rapid
decrease in cT1 with a significantly higher percentage of patients
achieving a ≥80 ms reduction (recovering from an at-risk NASH
category)
- TERN-501 combined with TERN-101 resulted in efficacy
improvement or maintenance compared to TERN-501 monotherapy
- TERN-501 monotherapy arms demonstrated significant increases in
SHBG and improved lipid levels, including significant reductions in
apolipoprotein B (ApoB) and a decrease in low-density lipoprotein
(LDL) levels, when combined with TERN-101
- TERN-501 was generally well tolerated, with treatment-related
adverse events (AEs) similar to the placebo group
- Overall, there were low rates of gastrointestinal AEs reported
similarly across all treatment arms
- No treatment-related cardiovascular AEs or serious AEs were
reported
“The acceptance of this late-breaking analysis of our Phase 2a
DUET study for patients with non-cirrhotic NASH at one of the most
prestigious liver meetings in the world is further validation that
we are advancing important research that has the potential to
transform the treatment of this serious disease,” said Erin Quirk,
M.D., president and head of research and development at Terns.
“These top-line data of TERN-501 are encouraging, with significant
reductions in key biomarkers including liver fat content, MRI-PDFF,
and cT1, a marker of fibro-inflammation. The positive efficacy and
safety profile of TERN-501 supports our belief that it has the
potential to become the THR-β monotherapy of choice and potentially
a mainstay backbone of combination therapies for people living with
NASH who are in desperate need of treatment options.”
The presentation will be made available on the Scientific
Publications portion of the Terns website.
In-Person Investor Event Information
Terns will host an investor reception event during The Liver
Meeting in Boston on Monday, November 13 at 4:00 p.m. ET.
Interested investors may reach out to RSVP at
investors@ternpharma.com.
About the Phase 2a DUET TrialThe Phase 2a DUET
trial (NCT05415722) is a multicenter, randomized, double-blind,
placebo-controlled clinical trial in non-cirrhotic NASH, designed
to evaluate efficacy and safety of TERN-501 as a monotherapy and in
combination with TERN-101. The trial enrolled over 160 adults with
body mass index (BMI) ≥ 25 kg/m2 and pre-cirrhotic NASH
identified based on prior liver biopsy and/or imaging and clinical
criteria. All participants had liver fat content measured by
magnetic resonance imaging proton density fat fraction (MRI-PDFF)
of ≥10%, MRI corrected T1 (cT1) relaxation time of ≥ 800 msec and
met other inclusion and exclusion criteria. The trial included a
12-week treatment period and a 4-week follow-up period. The primary
endpoint was the relative change from baseline in MRI-PDFF at Week
12 for TERN-501 monotherapy compared to placebo. Secondary
endpoints included assessments of relative change from baseline in
MRI-PDFF for TERN-501+TERN-101 combination compared to placebo and
change from baseline in cT1 for TERN-501 monotherapy compared to
placebo as well as for TERN-501+TERN-101 combination therapy
compared to placebo.
About Non-alcoholic Steatohepatitis (NASH)NASH
is a severe form of non-alcoholic fatty liver disease (NAFLD) that
affects up to 20 million people in the United States, and up to 5%
of the global population, and for which there is currently no
approved therapy in the United States or Europe. In a study
published in Hepatology in 2018, lifetime costs of treating and
managing NASH patients in the United States in 2017 were estimated
to be over $220 billion, in the absence of approved therapies. NASH
is a multifaceted disease that involves three distinct pathogenic
hepatic disease processes: accumulation of excess fat in the liver
(steatosis), inflammation and fibrosis. In addition to these three
disease processes, NASH patients often exhibit elevated levels of
glucose and atherogenic lipids, are overweight or obese and
accumulate excessive lipotoxic fat. Severe progression of NASH can
lead to cirrhosis, decompensated liver disease and increased risk
for hepatic carcinoma and liver-related mortality.
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, and a THR-β agonist, and a preclinical GIPR
modulator 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 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, including the results of
any interactions with regulatory authorities on its programs; 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; and the
Company’s plans for and ability to continue to execute on its
current development strategy, including potential combinations
involving multiple product candidates. 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
Terns Pharmaceuticals (NASDAQ:TERN)
Historical Stock Chart
From Aug 2024 to Sep 2024
Terns Pharmaceuticals (NASDAQ:TERN)
Historical Stock Chart
From Sep 2023 to Sep 2024