SAN DIEGO, Feb. 14, 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 an
agreement with PoC Capital, LLC to fund Viking's initial clinical
development of VK2809 in glycogen storage disease type Ia (GSD
Ia). Viking plans to file an Investigational New Drug (IND)
application for VK2809 for the treatment of GSD Ia and initiate a
human proof-of-concept study in the second half of 2017.
Under the terms of the agreement, PoC Capital will be
responsible for paying up to $1.8
million in expenses associated with VK2809 clinical studies,
including a planned proof-of-concept trial in patients with GSD
Ia. In exchange, up to $1.8
million in Viking shares will be issued to PoC Capital.
Viking's agreement with PoC Capital follows the company's recent
announcement of positive top-line results from a proof-of-concept
study of VK2809 in an in vivo model of GSD Ia. Data
from the study, conducted under a sponsored research agreement
between Duke University and Viking,
demonstrated that treatment with VK2809 led to statistically
significant reductions in key metabolic markers of GSD Ia.
Mean liver triglyceride content was reduced by more than 60% in
VK2809-treated animals relative to vehicle-treated control animals,
while average liver weight was reduced by more than 30% vs.
controls. In addition, average liver weight as a percent of
total body weight declined by approximately 20% in treated vs.
control animals. The ongoing study is continuing to evaluate
the impact of VK2809 on these and other disease markers.
Detailed data will be submitted for presentation at an appropriate
scientific conference.
GSD Ia is a rare, orphan genetic disease characterized by an
inability to metabolize glucose precursors, resulting in
hypoglycemia and increased lipogenesis. The disease is caused
by mutations in the gene for glucose-6-phosphatase (G6PC), a
critical enzyme involved in the production of glucose from either
glycogen or gluconeogenesis. Impaired G6PC function leads to
dramatically elevated liver triglyceride levels in human patients
and in animal models of the disease. In patients, this may
contribute to serious long-term complications, such as severe
hepatomegaly, hepatic adenomas, and hepatocellular carcinoma.
Manifestations of the disease begin to appear shortly after
birth and continue through adolescence into adulthood. There
is currently no approved pharmacologic therapy for GSD Ia.
"We are pleased to enter into this agreement with PoC Capital as
it will allow us to conduct the initial clinical work evaluating
VK2809 in GSD Ia in a capital efficient manner. We view GSD
Ia as an attractive development opportunity for VK2809, where we
can leverage prior human data showing the drug candidate's robust
effect on plasma triglycerides, as well as our recent results
demonstrating promising efficacy in an animal model of the
disease," said Brian Lian, Ph.D.,
chief executive officer of Viking. "GSD Ia is an indication
with a high unmet medical need where we believe VK2809 could yield
important benefits to patients who have otherwise limited
therapeutic options. As such, we are interested in evaluating
the drug candidate's potential effects in a clinical
proof-of-concept study."
"In collaboration with researchers from Duke University, the team at Viking has generated
encouraging data in a model of GSD Ia, a rare genetic condition.
We are very pleased to support Viking's plan to run a
proof-of-concept study with VK2809, a selective thyroid hormone
receptor beta agonist," said Daron
Evans, managing director of PoC Capital. "Viking's
strong research team has the potential to open the door to this and
other potential orphan indications with their deep pipeline of
therapeutic products."
VK2809 is a novel, orally available small molecule thyroid
receptor beta (TRβ) agonist that possesses selectivity for liver
tissue, as well as the beta receptor subtype, suggesting promising
therapeutic potential in a range of lipid disorders. Viking
is currently evaluating VK2809 in a randomized, double-blind,
placebo-controlled, parallel group Phase 2 study designed to assess
the drug candidate's efficacy, safety and tolerability in
approximately 80 patients with elevated LDL-C and non-alcoholic
fatty liver disease. Previously reported clinical data have
demonstrated that treatment with VK2809 leads to significant
reductions in plasma triglycerides, LDL cholesterol (LDL-C), and
atherogenic protein levels in subjects with mild
hypercholesterolemia.
About GSD Ia
Glycogen storage disease Ia (GSD Ia) is a
rare, orphan genetic disease caused by a deficiency of
glucose-6-phosphatase (G6PC), an enzyme responsible for the liver's
production of glucose from glycogen and gluconeogenesis. The
disease, for which there is no approved pharmacologic therapy,
results in an excess accumulation of glycogen and lipids in the
liver, potentially leading to hepatic steatosis, liver failure,
development of hepatic adenomas, and hepatocellular
carcinoma. Increased triglyceride production and elevated
triglyceride levels are characteristic of GSD Ia and associated
with many manifestations of the disease. GSD Ia is estimated
to occur in approximately 1 in every 50,000 – 100,000 births in the
United States. As manifestations of the disease begin to
present themselves at birth, a sizeable portion of GSD Ia patients
are children.
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 also plans to
initiate a proof-of-concept study of VK2809 in patients with
glycogen storage disease type Ia. The company 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.
Follow Viking on Twitter @Viking_VKTX.
About PoC Capital
PoC Capital, LLC (www.poccap.com)
invests in life science companies whose therapeutics, devices or
diagnostics have the opportunity to improve patient health and
well-being. Strong management teams, clear mechanisms of action,
and well-validated product development plans are key components of
PoC's investment thesis. PoC Capital provides targeted funding for
companies to execute proof-of-concept clinical trials that have the
potential to unlock the value of development-stage assets through
safety and efficacy validation.
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 and VK2809'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 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.
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/viking-therapeutics-and-poc-capital-enter-agreement-to-fund-clinical-development-of-vk2809-in-glycogen-storage-disease-ia-gsd-ia-300406828.html
SOURCE Viking Therapeutics, Inc.