SAN DIEGO, Oct. 4, 2016 /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
that the first patient has been dosed in the company's Phase 2
clinical trial of VK2809 in patients with primary
hypercholesterolemia and non-alcoholic fatty liver disease.
VK2809 is a novel, orally available small molecule thyroid receptor
agonist that possesses selectivity for liver tissue, as well as the
beta receptor subtype, suggesting promising therapeutic potential
in this patient population.
The Phase 2 clinical trial is a randomized, double-blind,
placebo-controlled, parallel group study designed to evaluate the
efficacy, safety and tolerability of VK2809 in approximately 80
patients with elevated LDL cholesterol (LDL-C) and non-alcoholic
fatty liver disease. Patients will be randomized to receive
once-daily oral doses of VK2809 or placebo for 12 weeks followed by
a four-week off-drug phase. The trial's primary endpoint will
evaluate the effect of VK2809 treatment on LDL-C after 12 weeks
compared to placebo. Secondary and exploratory endpoints
include assessments of changes in liver fat content, triglycerides,
and inflammatory markers.
"We are excited to have this trial underway as it represents an
important milestone for both the company and the development of
novel treatments for hypercholesterolemia and fatty liver
disease. This study will be critical in validating VK2809's
unique liver-targeted mechanism of action, which we believe
provides differentiated benefits by simultaneously reducing hepatic
steatosis, an important driver of non-alcoholic steatohepatitis
(NASH), and improving plasma lipid levels," said Brian Lian, Ph.D., chief executive officer of
Viking. "Prior data have shown that treatment with VK2809 can
lead to rapid histologic improvement in animal models of hepatic
steatosis, as well as significant reductions in LDL-C,
triglycerides, and atherogenic proteins in humans. Along with
our ongoing Phase 2 trial of VK5211 in hip fracture, this trial
will provide a second important Phase 2 study readout that we
expect will demonstrate the potential value of our pipeline of
novel therapies for metabolic and endocrine disorders."
About VK2809
VK2809 is an orally available, tissue and
receptor-subtype selective agonist of the thyroid beta receptor in
Phase 2 development for the treatment of patients with
hypercholesterolemia and fatty liver disease. VK2809 belongs
to a family of novel prodrugs which are cleaved in vivo to
release potent thyromimetics. Selective activation of the TRß
receptor in liver tissue is believed to favorably affect
cholesterol and lipoprotein levels via multiple mechanisms,
including increasing the expression of low-density lipoprotein
(LDL) receptors and increasing mitochondrial fatty acid oxidation.
In a Phase 1b study in patients with mild hypercholesterolemia,
treatment with VK2809 resulted in placebo-adjusted reductions in
low-density lipoprotein that exceeded 40% at high doses.
Patients also experienced significant reductions in triglycerides,
as well as the atherogenic proteins lipoprotein-a and
apolipoprotein B. Consistent with its liver- and
receptor-selective mechanism of action, treatment with VK2809 has
also demonstrated rapid reduction of liver fat in animal models of
hepatic steatosis. Further animal data have shown that VK2809
has additive cholesterol lowering activity in combination with
statins. These characteristics suggest a highly
differentiated therapeutic profile relative to existing oral
options for patients with hypercholesterolemia and fatty liver
disease, such as nonalcoholic steatohepatitis (NASH). The
potential markets for these indications are significant. In
the U.S., approximately 33% of adults, or 71 million people, have
elevated LDL cholesterol. Additionally, NASH is becoming
recognized as a leading cause of cirrhosis and liver failure and
affects an estimated 6 to 15 million Americans.
About Viking Therapeutics, Inc.
Viking Therapeutics,
Inc. is a clinical-stage biopharmaceutical company focused on the
development of novel, first-in-class or best-in-class therapies for
metabolic and endocrine disorders. The company's research and
development activities leverage its expertise in metabolism to
develop innovative therapeutics designed to improve patients'
lives. Viking has exclusive worldwide rights to a portfolio
of five therapeutic programs in clinical trials or preclinical
studies, which are based on small molecules licensed from Ligand
Pharmaceuticals Incorporated. The company's clinical programs
include VK5211, an orally available, non-steroidal selective
androgen receptor modulator, or SARM, in Phase 2 development for
the treatment and prevention of lean body mass loss in patients who
have undergone hip fracture surgery, VK2809, a small molecule
thyroid beta agonist in Phase 2 development for
hypercholesterolemia and fatty liver disease, and VK0612, a
first-in-class, orally available drug candidate in Phase 2
development for type 2 diabetes. Viking is also developing
novel and selective agonists of the thyroid beta receptor for
adrenoleukodystrophy, as well as two earlier-stage programs
targeting metabolic diseases and anemia.
Forward-Looking Statements
This press release
contains forward-looking statements regarding Viking Therapeutics,
including statements about Viking's expectations regarding its
development activities, timelines and milestones, as well as the
company's goals and plans regarding VK2809. Forward-looking
statements are subject to risks and uncertainties that could cause
actual results to differ materially 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; and risks regarding
regulatory requirements, among others. These forward-looking
statements speak only as of the date hereof. Viking disclaims
any obligation to update these forward-looking statements.
Follow Viking on Twitter @Viking_VKTX.
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SOURCE Viking Therapeutics, Inc.