SAN DIEGO, Oct. 4, 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
that the results from the company's Phase 2 study of VK2809 in
patients with non-alcoholic fatty liver disease (NAFLD) and
elevated low-density lipoprotein cholesterol (LDL-C) have been
selected for presentation as part of the oral late-breaker session
of The Liver Meeting® 2018. The presentation will
highlight data from the recently completed Phase 2 clinical trial
of VK2809. The Liver Meeting 2018, which is the annual
meeting of the American Association for the Study of Liver Diseases
(AASLD), is being held November 9 –
13 in San Francisco,
CA.
Details of Viking's scheduled presentation are as follows:
- Title: VK2809, a Novel Liver-Directed Thyroid Receptor
Beta Agonist, Significantly Reduces Liver Fat in Patients with
Non-Alcoholic Fatty Liver Disease: A Phase 2 Randomized,
Placebo-Controlled Trial
- Publication Number: lLB-4
- Presentation Type: Oral Late-Breaker
- Presenter: Rohit Loomba,
MD, MHSc
- Session: Late-breaking Abstract Oral Session I
- Session Date/Time: Monday, November 12, 2018,
3:00 PM
- Presentation Time: 3:45 pm Pacific
- Presentation Location: Hall D - General Session, Moscone
Center, North and South Buildings
VK2809, Viking's lead development program, is an orally
available, tissue and receptor-subtype selective agonist of the
thyroid beta receptor (TRβ) that possesses selectivity for liver
tissue, as well as the beta receptor subtype, suggesting promising
therapeutic potential in a range of lipid disorders. The Phase 2
study was a randomized, double-blind, placebo-controlled,
parallel-group study designed to evaluate the efficacy, safety and
tolerability of VK2809 in patients with elevated LDL-C and NAFLD.
As previously reported, the top-line data from this study showed
that the trial successfully achieved its primary endpoint, with
patients receiving VK2809 demonstrating statistically significant
reductions in LDL-C compared with placebo. In addition, the
trial's secondary endpoint was achieved, with VK2809-treated
patients experiencing statistically significant reductions in liver
fat content compared with placebo, and a majority experiencing ≥50%
reductions. VK2809 also demonstrated encouraging safety and
tolerability in this study, with no serious adverse events reported
among patients receiving VK2809 or placebo.
"We look forward to sharing the results of our recently
completed Phase 2 trial of VK2809 as part of the oral late-breaker
session at The Liver Meeting," stated Brian
Lian, Ph.D., Viking's chief executive officer. "The
observed effects on liver fat and plasma lipids in this study
highlight the promise of VK2809 as a potentially best-in-class
thyroid beta agonist for treating fatty liver diseases, including
NAFLD and non-alcoholic steatohepatitis (NASH)."
About VK2809
VK2809 is an orally available, tissue and
receptor-subtype selective agonist of the thyroid beta receptor
(TRβ) that possesses selectivity for liver tissue, as well as the
beta receptor subtype, suggesting promising therapeutic potential
in a range of lipid disorders. The compound successfully achieved
primary and secondary endpoints in a Phase 2 study for the
treatment of patients with elevated LDL-C and non-alcoholic fatty
liver disease (NAFLD). The company is also preparing to
evaluate VK2809 in a Phase 1 study for the treatment of patients
with GSD Ia. 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 genes associated with lipid metabolism and
clearance.
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,
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,
timelines and milestones, as well as the company's goals 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
VK5211 and VK2809; risks that prior clinical and preclinical
results may not be replicated; risks regarding regulatory
requirements; 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, 2017, 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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SOURCE Viking Therapeutics, Inc.