SAN DIEGO, Aug. 28, 2020 /PRNewswire/ -- Viking
Therapeutics, Inc. (Viking) (NASDAQ: VKTX), a clinical-stage
biopharmaceutical company focused on the development of novel
therapies for metabolic and endocrine disorders, today announced
the presentation of new results from the company's 12-week Phase 2
study of VK2809 in patients with non-alcoholic fatty liver disease
(NAFLD) and elevated low-density lipoprotein cholesterol (LDL-C) at
the Digital International Liver Congress™ 2020. The
study results were featured in an oral presentation at the annual
meeting of the European Association for the Study of the Liver
(EASL), being held virtually August 27-29,
2020.
Highlights from the oral presentation include newly reported
data demonstrating that patients treated with VK2809 experienced
durable, statistically significant reductions in liver fat content
that were maintained at Week 16, four weeks after administration of
the last dose in the 12-week study. Additionally, new analyses
of 12 week study results demonstrated that patients receiving
VK2809 experienced significant reductions in liver fat content
irrespective of various baseline characteristics and common risk
factors for non-alcoholic steatohepatitis (NASH).
Data presented at The Digital International Liver Congress 2020
include:
Reduction in Liver Fat Content at Week 16
At Week 16, four weeks following completion of treatment, study
results demonstrated that VK2809-treated patients maintained
statistically significant reductions in liver fat content, both as
compared to baseline and as compared to placebo. VK2809-treated
patients experienced a statistically significant median reduction
in liver fat content of 45.4% at Week 16 as compared to an 18.7%
reduction for placebo. Additionally, at Week 16, 70.4% of all
VK2809-treated patients were still considered responders,
experiencing ≥ 30% relative reduction from baseline in liver fat
content, as compared to 22.2% for placebo-treated patients. Of
note, 100% of patients receiving 5 mg of VK2809 dosed daily were
still considered responders at Week 16. These results
highlight the durability of liver fat content reduction achieved
with VK2809 treatment, as patients received their final dose of
VK2809 at Week 12, four weeks prior to the Week 16 assessments. The
overall data from this study provide strong rationale for further
development of VK2809 in the setting of NASH, and may indicate
opportunities for multiple dosing strategies, including chronic,
intermittent, or the potential cycling of treatment modalities.
Week 16
Results
|
Placebo
|
All
VK2809-Treated
|
Percentage of
patients experiencing ≥ 30% reduction in liver fat
|
22.2%
|
70.4%
(p=0.0083 vs.
placebo)
|
Median relative %
change in liver fat by MRI-PDFF
|
-18.7%
|
-45.4%
(p=0.0053 vs.
placebo)
|
Mean absolute %
change in liver fat by MRI-PDFF
|
-2.0%
|
-7.5%
(p=0.0027 vs.
placebo)
|
"We are pleased with the durability of therapeutic response
achieved with VK2809 in this study. Not only did patients
receiving VK2809 maintain significant liver fat reductions many
weeks after their final study dose, but more than 70% of all
VK2809-treated patients still qualified as responders four weeks
post-treatment," said Brian Lian,
Ph.D., chief executive officer of Viking. "Responders, defined as
patients achieving at least a 30% decrease in liver fat content,
have been shown to demonstrate a higher probability of experiencing
histological improvement in NASH, making these results particularly
exciting. These latest results offer further support for what
we believe is a best-in-class therapeutic profile for VK2809 and we
look forward to completing our ongoing Phase 2b VOYAGE study in patients with biopsy-confirmed
NASH."
Consistent Reduction in Week 12 Liver Fat Content Reported
Across Baseline Characteristics and Common NASH Risk
Factors
Common NASH Risk Factors
New analyses of Week 12 study results demonstrated significant
reductions in liver fat content among patients receiving VK2809 as
compared to placebo regardless of the presence of common risk
factors for NASH, including baseline levels of alanine
aminotransferase (ALT) above the upper limit of normal (ALT >
xULN), body mass index (BMI) ≥ 30, hypertension and Hispanic
ethnicity.
Mean Relative %
Change in Liver Fat in NASH Risk Factor Subsets at Week
12
|
NASH Risk
Factor
|
Placebo
|
All
VK2809-Treated
|
Baseline ALT >
xULN
|
-2.1%
|
-57.4%
(p=0.0001 vs.
placebo)
|
BMI ≥ 30
|
-7.8%
|
-51.3%
(p=0.0151 vs.
placebo)
|
Hypertension (BP ≥
140 mmHg)
|
6.2%
|
-54.9%
(p=0.017 vs.
placebo)
|
Hispanic
Ethnicity
|
-7.2%
|
-49.0%
(p=0.0054 vs.
placebo)
|
Baseline Liver Fat Content and Baseline Glucose Levels
Newly presented data also demonstrated consistent reductions in
liver fat content levels for VK2809-treated patients across the
spectrum of baseline liver fat content levels. Similarly,
consistent liver fat content reductions were seen for
VK2809-treated patients at Week 12 regardless of baseline blood
glucose levels, including among those with normal baseline blood
glucose and those considered pre-diabetic.
"The consistency and durability of efficacy reported with VK2809
in this trial regardless of therapeutic dose, baseline patient
characteristics or underlying NASH risk factors is
encouraging. Particularly noteworthy is that VK2809-treated
patients with NASH risk factors including elevated baseline ALT,
obesity and hypertension experienced reductions in liver fat that
were significantly greater than observed among patients receiving
placebo," stated Rohit Loomba, M.D.,
MHSc, Director, NAFLD Research Center, and Professor of Medicine,
University of California at San Diego.
"These latest results build upon the impressive
previously-announced findings from this clinical trial and strongly
support the ongoing evaluation of VK2809 as a potential important
treatment for NASH."
As previously reported, the Phase 2 study of VK2089, Viking's
novel liver-selective thyroid receptor beta agonist, successfully
achieved both its primary and secondary efficacy endpoints,
demonstrating median relative reductions in liver fat ranging from
approximately 54% to 60%, and response rates of up to 100%, both of
which represent unprecedented efficacy from an oral
agent. Additionally, VK2809 was shown to be safe and well
tolerated at all doses evaluated in the study. No serious
adverse events were reported among patients receiving either VK2809
or placebo.
Viking is currently evaluating VK2809 in the Phase 2b VOYAGE study in patients with
biopsy-confirmed non-alcoholic steatohepatitis (NASH) and
fibrosis.
Study Design
The Phase 2 study was a randomized, double-blind,
placebo-controlled, parallel-group study designed to evaluate the
efficacy, safety and tolerability of VK2809 dosed orally in
patients with elevated LDL-C and NAFLD. Patients were
randomized to receive placebo, 5 mg VK2809 dosed daily, 10 mg
VK2809 dosed every other day, or 10 mg VK2809 dosed daily for 12
weeks. The trial's primary endpoint assessed the effect of
VK2809 treatment on LDL-C after 12 weeks compared to placebo. The
secondary endpoint evaluated changes in liver fat content by
magnetic resonance imaging, proton density fat fraction
(MRI-PDFF).
About VK2809 and the VOYAGE Trial
VK2809 is an orally available small molecule agonist of the
thyroid hormone receptor that possesses selectivity for liver
tissue, as well as the beta receptor subtype, and has demonstrated
promising therapeutic potential in a range of lipid disorders,
including NASH. In 2019, the company initiated the Phase
2b VOYAGE trial. This trial is a
randomized, double-blind, placebo-controlled, multicenter study
designed to assess the efficacy, safety and tolerability of VK2809
in patients with biopsy-confirmed NASH and fibrosis ranging from
stages F1 to F3. The study is targeting enrollment of approximately
340 patients across five treatment arms: 1.0 mg daily; 2.5 mg
daily; 5.0 mg every other day; 10.0 mg every other day; and
placebo.
The primary endpoint of the study will evaluate the relative
change in liver fat content, as assessed by MRI-PDFF from baseline
to Week 12 in subjects treated with VK2809, as compared to placebo.
Secondary objectives include evaluation of histologic changes
assessed by hepatic biopsy after 52 weeks of dosing. The
study's independent data monitoring committee recently convened as
part of its scheduled review process and recommended that VOYAGE
continue as planned.
About Viking Therapeutics, Inc.
Viking Therapeutics is a clinical-stage biopharmaceutical
company focused on the development of novel, orally available,
first-in-class or best-in-class therapies for the treatment of
metabolic and endocrine disorders. Viking's research and
development activities leverage its expertise in metabolism to
develop innovative therapeutics designed to improve patients'
lives. The company's clinical programs include VK2809, a novel,
orally available, small molecule selective thyroid hormone receptor
beta agonist for the treatment of lipid and metabolic disorders,
which is currently being evaluated in a Phase 2b study
for the treatment of biopsy-confirmed non-alcoholic steatohepatitis
(NASH) and fibrosis. In a Phase 2 trial for the treatment of
non-alcoholic fatty liver disease (NAFLD) and elevated LDL-C,
patients who received VK2809 demonstrated statistically significant
reductions in LDL-C and liver fat content compared with patients
who received placebo. The company is also developing VK0214, a
novel, orally available, small molecule selective thyroid hormone
receptor beta agonist for the treatment of X-linked
adrenoleukodystrophy (X-ALD). The company holds exclusive
worldwide rights to a portfolio of five therapeutic programs,
including those noted above, which are based on small molecules
licensed from Ligand Pharmaceuticals Incorporated.
For more information about Viking Therapeutics, please visit
www.vikingtherapeutics.com. Follow Viking on Twitter
@Viking_VKTX.
Forward-Looking Statements
This press release contains forward-looking statements
regarding Viking Therapeutics, Inc., under the safe harbor
provisions of the U.S. Private Securities Litigation Reform Act of
1995, including statements about Viking's expectations regarding
its development activities and plans regarding VK2809 and its
prospects. Forward-looking statements are subject to risks and
uncertainties that could cause actual results to differ materially
and adversely and reported results should not be considered as an
indication of future performance. These risks and uncertainties
include, but are not limited to: risks associated with the success,
cost and timing of Viking's product candidate development
activities and clinical trials, including those for VK2809 and
VK0214; risks that prior clinical and preclinical results may not
be replicated; risks regarding regulatory requirements; risks
related to the COVID-19 pandemic; and other risks that are
described in Viking's most recent periodic reports filed with the
Securities and Exchange Commission, including Viking's Annual
Report on Form 10-K for the year ended December 31, 2019, and
subsequent Quarterly Reports on Form 10-Q, including the risk
factors set forth in those filings. These forward-looking
statements speak only as of the date hereof. Viking disclaims
any obligation to update these forward-looking statements except as
required by law.
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