SAN DIEGO, Nov. 28, 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
positive results from a 12-week, Phase 2 clinical trial of VK5211
in patients who recently suffered a hip fracture. Top-line
data showed that the trial achieved its primary endpoint,
demonstrating statistically significant, dose dependent increases
in lean body mass, less head, following treatment with VK5211 as
compared to placebo. The study also achieved important
secondary endpoints, demonstrating statistically significant
increases in appendicular lean body mass and total lean body mass
for all doses of VK5211, compared to placebo. VK5211
demonstrated encouraging safety and tolerability in this study,
with no drug-related serious adverse events (SAEs) reported.
VK5211, Viking'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 Phase 2 clinical trial was a randomized,
double-blind, placebo-controlled, parallel group, international
study designed to evaluate the efficacy, safety and tolerability of
VK5211 in patients recovering from hip fracture surgery. A
total of 108 patients were randomized to receive once-daily VK5211
doses of 0.5 mg, 1.0 mg, 2.0 mg, or placebo for 12 weeks.
Top-line results include:
- All doses of VK5211 demonstrated statistically significant
increases in total lean body mass, less head, the study's primary
endpoint. Placebo-adjusted increases in lean body mass were
4.8% at 0.5 mg (p < 0.005), 7.2% at 1.0 mg (p < 0.001), and
9.1% at 2.0 mg (p < 0.001). These corresponded to
placebo-adjusted increases of 1.6 kg at 0.5 mg (p < 0.005), 2.5
kg at 1.0 mg (p < 0.001), and 3.1 kg at 2.0 mg (p <
0.001).
- The proportion of patients experiencing at least a 5% increase
in total lean body mass, less head, were 19% with placebo, 61% at
0.5 mg, 65% at 1.0 mg, and 75% at 2.0 mg (p < 0.01 for
each). The proportion of patients demonstrating at least a
2.0 kg gain in total lean body mass, less head, were 14% with
placebo, 57% at 0.5 mg, 65% at 1.0 mg, and 81% at 2.0 mg (p <
0.01 for each).
- All doses of VK5211 produced statistically significant
increases in appendicular lean body mass, a secondary efficacy
endpoint. Placebo-adjusted increases in appendicular lean
body mass were 6.1% at 0.5 mg (p < 0.01), 9.0% at 1.0 mg (p <
0.001), and 10.2% at 2.0 mg (p < 0.001). These
corresponded to placebo-adjusted increases of 0.8 kg at 0.5 mg (p
< 0.05), 1.3 kg at 1.0 mg (p < 0.001), and 1.4 kg at 2.0 mg
(p < 0.001).
- All doses of VK5211 produced statistically significant
increases in total lean body mass, including head, a secondary
efficacy endpoint. Placebo-adjusted increases in lean body
mass were 4.7% at 0.5 mg (p < 0.005), 6.8% at 1.0 mg (p <
0.001), and 8.3% at 2.0 mg (p < 0.001). These corresponded
to placebo-adjusted increases of 1.7 kg at 0.5 mg (p < 0.005),
2.6 kg at 1.0 mg (p < 0.001), and 3.1 kg at 2.0 mg (p <
0.001).
- Patients receiving VK5211 demonstrated numerical improvements
in certain exploratory assessments of functional performance,
including the 6-minute walk test and short physical performance
battery, compared with placebo. These endpoints were not
powered for significance. Further evaluation of exploratory
functional endpoints is underway.
- There were no significant differences in the rates of adverse
events reported among patients receiving VK5211 compared with
placebo. There were no dose-related differences in reported
adverse events among various VK5211 treatment groups. No
drug-related SAEs were observed in patients receiving VK5211.
"We are pleased that this trial succeeded in both the primary
efficacy endpoint, as well as important secondary endpoints,
demonstrating VK5211's potential benefit in this setting. The
study achieved statistical significance at all doses with a clear
dose-response and, in our view, provides compelling evidence of
VK5211's potent pharmacologic effect on muscle growth," said
Brian Lian, Ph.D., chief executive
officer of Viking. "We are also encouraged by VK5211's
preliminary safety and tolerability profile, particularly by the
fact that no drug-related SAEs were observed. This is
important to note given the medically fragile profile of hip
fracture patients, many of whom are older adults with multiple
comorbidities requiring multiple concomitant therapies. We
are gratified to see VK5211 produce such robust pharmacologic
effects along with a promising safety profile in this challenging
population."
"The degree of improvement in lean body mass in this group of
older persons who are prone to losing muscle is impressive.
Having a drug like this available that can be taken easily
and safely soon after hip fracture would provide a valuable adjunct
to other therapeutic strategies such as physical therapy and a
protein-rich diet to boost patients' chances for resuming usual
activities," said Jay Magaziner,
PhD, MSHyg, Professor and Chair, Department of Epidemiology and
Public Health at the University of Maryland
School of Medicine and an international authority on the
consequences of hip fracture.
Viking intends to present additional results from the Phase 2
study at an upcoming scientific conference(s).
Conference Call Today at 8:00 am
ET
Viking will hold a conference call today at 8:00 am ET to discuss the results of the Phase 2
study of VK5211. To participate on the conference call,
please dial (844) 850-0543 from the U.S. or (412) 317-5199 from
outside the U.S. Those interested in listening to the
conference call live via the internet may do so by visiting the
Investor Relations section of Viking's website at
www.vikingtherapeutics.com. An archive of the webcast will be
available for 7 days on the company's website at
www.vikingtherapeutics.com.
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
preclinical 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 non-alcoholic 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.