SAN DIEGO, Oct. 1, 2018 /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 new findings from the company's 12-week, Phase 2 clinical
trial of VK5211 in patients who recently suffered a hip
fracture. As previously reported, 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. Additionally,
newly presented data demonstrated dose-dependent decreases in mean
fat mass, coupled with dose-dependent increases in mean body weight
following VK5211 treatment. Findings also demonstrated
dose-dependent increases in 6-minute walk distance following VK5211
treatment, reaching a greater than 20-meter improvement over
placebo at the study's highest dose. The results were
presented as part of the oral plenary session of the American
Society for Bone and Mineral Research (ASBMR) 2018 annual meeting,
held September 28 – October 1, 2018 in Montreal, Quebec, Canada.
VK5211, Viking's lead program for musculoskeletal 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.
Key results presented at ASBMR included:
- All doses of VK5211 demonstrated statistically significant
increases in total lean body mass, less head, following 12 weeks of
treatment, the study's primary endpoint. Placebo-adjusted
increases in lean body mass were 4.8% at 0.5 mg (p = 0.0032), 7.2%
at 1.0 mg (p < 0.0001), and 9.1% at 2.0 mg (p < 0.0001).
- Patients receiving VK5211 experienced dose-dependent decreases
in mean fat mass following 12 weeks of treatment, which reached
statistical significance at the study's highest dose of 2.0
mg. Placebo-adjusted reductions in mean fat mass were
approximately 2.2% at 0.5 mg, 5.4% at 1.0 mg, and 6.2% at 2.0 mg (p
= 0.01).
The observed reductions in mean fat mass were coupled with
dose-dependent increases in mean body weight following 12 weeks of
treatment, demonstrating beneficial changes in overall body
composition among VK5211-treated subjects. The increases in
mean body weight were 2.54 kg at 0.5 mg, 2.95 kg at 1.0 mg, and
3.09 kg at 2.0 mg.
- Patients receiving VK5211 demonstrated dose-dependent
improvements in the 6-minute walk distance as compared to placebo,
though this exploratory endpoint was not powered for
significance. For patients in the 2.0 mg VK5211 treatment
arm, the mean distance increased by approximately 22 meters
compared to placebo.
- VK5211 treatment resulted in statistically significant
improvements compared to placebo in serum procollagen type 1
propeptide (s-P1NP), a marker of anabolic bone turnover, at 12
weeks.
- Patients were also assessed 12 weeks after completion of the
study to evaluate safety and efficacy at 24 weeks. At this
24-week timepoint, the increases in total lean body mass, less
head, for all VK5211 treatment arms remained above placebo, though
the increases were no longer statistically significant. The
durable increases in muscle mass that were maintained three months
following the last dose of VK5211 highlight the potent treatment
effect VK5211 demonstrated in these patients.
- No drug-related SAEs were observed in patients receiving
VK5211. 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.
"This study highlights the impressive efficacy and safety of
VK5211 in a population where no treatment option currently
exists. The impressive changes to weight and lean body mass,
which exceeded six pounds in the highest dose group, demonstrate
VK5211's potent effect in patients who are often characterized as
frail and prone to prolonged disability. It is striking that
these increases were coupled with reductions in fat mass,
indicating a favorable shift in overall body composition," said
Brian Lian, Ph.D., chief executive
officer of Viking. "In addition, while the study was not
powered to demonstrate statistical significance on exploratory
endpoints, we are encouraged by the dose-dependent increases in
6-minute walk distance, which exceeded placebo by more than 20
meters at the study's highest dose, suggesting a potential
functional benefit to patients. Finally, we are pleased with
the safety and tolerability of VK5211 in this study, with no
drug-related serious adverse events observed and no clinically
meaningful changes in important markers such as hemoglobin, red
blood cell counts and coagulation factors."
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.
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. The company's clinical programs include VK2809, a
small molecule thyroid beta agonist. In a Phase 2 trial for
the treatment of non-alcoholic fatty liver disease and elevated
LDL-C, patients who received VK2809 demonstrated statistically
significant reductions in LDL-C and liver fat content. VK2809 was
shown to be safe and well-tolerated in the study. The
company's second clinical program is VK5211, an orally available,
non-steroidal selective androgen receptor modulator. In a
Phase 2 trial in patients recovering from hip fracture, patients
who received VK5211 experienced significant improvements in
measures of lean body mass compared to patients who received
placebo. The company is also developing VK0612, a
first-in-class, orally available drug candidate in Phase 2
development for type 2 diabetes. Additional programs include
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. Viking
holds exclusive worldwide rights to a portfolio of five therapeutic
programs in clinical trials or preclinical studies, including those
noted above, which are based on small molecules licensed from
Ligand Pharmaceuticals Incorporated.
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.