SAN DIEGO, July 12, 2017 /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 enrollment has been completed in the company's ongoing Phase 2
clinical trial of VK5211 in patients who recently suffered a hip
fracture. VK5211, the company's lead program for muscle and
bone disorders, is an orally available, non-steroidal selective
androgen receptor modulator (SARM) designed to selectively
stimulate muscle and bone formation with reduced activity in
peripheral tissues such as skin and prostate. The company
believes these characteristics may provide important benefits to
patients recovering from hip fracture.
The Phase 2 clinical trial is a randomized, double-blind,
placebo-controlled, parallel group study designed to evaluate the
efficacy, safety and tolerability of VK5211 in patients recovering
from hip fracture surgery. A total of 108 patients have been
randomized to receive once-daily VK5211 doses of 0.5 mg, 1.0 mg,
2.0 mg, or placebo for 12 weeks. The study's primary endpoint
will evaluate the effects of VK5211 on lean body mass after 12
weeks of treatment. Secondary and exploratory objectives
include assessments of functional performance, quality-of-life, and
activities of daily living, as well as safety, tolerability and
pharmacokinetics. Viking expects to announce results from
this trial in the fourth quarter.
"We are excited to have reached this important milestone with
our VK5211 program and look forward to reporting top-line data
later this year," said Brian Lian,
Ph.D., chief executive officer of Viking. "Prior results from
studies evaluating VK5211 in animals and humans have demonstrated
promising anabolic effects on bone and muscle mass. These
characteristics highlight the potential benefits VK5211 may provide
in patients recovering from hip fracture, an injury that results in
more than 300,000 hospitalizations in the U.S. each year.
Following the fracture, patients are prone to accelerated losses of
bone and muscle, resulting in prolonged disability, morbidity, and
risk of mortality. We believe VK5211's potent anabolic
effects on bone and muscle have the potential to address many of
the key unmet needs of these individuals."
About VK5211
VK5211 is an orally available,
non-steroidal selective androgen receptor modulator (SARM) in Phase
2 development for the treatment of patients recovering from
non-elective hip fracture surgery. VK5211 belongs to a family
of novel orally available, non-steroidal SARM compounds based on
tissue-specific gene expression and other functional, cell-based
technologies. Viking believes that VK5211 has the potential
to produce the therapeutic benefits of testosterone with improved
safety, tolerability and patient acceptance due to a
tissue-selective mechanism of action and an oral route of
administration. In Phase 1 clinical trials, VK5211
demonstrated statistically significant increases in lean body mass
among treated subjects following 21 days of treatment. In a
pre-clinical model of osteoporosis, VK5211 demonstrated
improvements in bone mineral density, bone mineral content, bone
strength, and other measures.
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 GSD
Ia and X-linked adrenoleukodystrophy, as well as two earlier-stage
programs targeting metabolic diseases and anemia.
Follow Viking on Twitter @Viking_VKTX.
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 VK5211 and VK5211's prospects.
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, including those for VK5211 and VK2809; risks that prior
clinical and pre-clinical results may not be replicated; 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.
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SOURCE Viking Therapeutics, Inc.