SAN DIEGO, Nov. 19, 2019 /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
the initiation of a Phase 2b clinical
trial of VK2809, its novel liver-selective thyroid hormone receptor
beta agonist, in patients with biopsy-confirmed non-alcoholic
steatohepatitis (NASH). Clinical trial sites are open for
patient enrollment following clearance of the company's
Investigational New Drug (IND) application by the United States
Food and Drug Administration (FDA).
The VOYAGE study is a randomized, double-blind,
placebo-controlled, multicenter trial designed to assess the
efficacy, safety and tolerability of VK2809 in patients with
biopsy-confirmed NASH and fibrosis ranging from stages F1 to
F3. Patients with certain comorbid conditions such as type 2
diabetes, as well as patients receiving certain lipid-lowing
medications, including statins, are eligible for enrollment.
The study will target enrollment of approximately 340
patients across five treatment arms: VK2809 1.0 mg daily; VK2809
2.5 mg daily; VK2809 5.0 mg every other day; VK2809 10.0 mg every
other day; and placebo.
The primary endpoint of the study will evaluate the relative
change in liver fat content, as assessed by magnetic resonance
imaging, proton density fat fraction (MRI-PDFF), from baseline to
Week 12 in subjects treated with VK2809 as compared to
placebo. Secondary objectives include evaluation of
histologic changes assessed by hepatic biopsy after 52 weeks of
dosing. The trial has received clearance for the first six
months of dosing and, subject to submission and satisfactory
regulatory review of data from recently completed 12-month toxicity
studies, patients will continue to receive VK2809 for the planned
52-week treatment duration.
"We are excited to advance VK2809 into the next stage of
development and look forward to assessing its safety and efficacy
in this important trial. The initiation of the VOYAGE study
represents the culmination of significant effort by the Viking
team, including the successful execution of several key clinical
and non-clinical studies to support a new IND, which
was recently filed with the FDA's Division of Gastrointestinal
and Inborn Errors Products," stated Brian
Lian, Ph.D., chief executive officer of Viking. "We
believe the results from our previously announced 12-week Phase 2
trial in subjects with hypercholesterolemia and NAFLD provide a
compelling proof-of-concept signal that we intend to further
explore in this study. Given the high unmet need for new
therapies to treat NASH, and VK2809's promising initial data on
both liver fat and plasma lipids, we plan to move forward as
quickly as possible to demonstrate the drug's potential benefit in
this setting."
VK2809 has been evaluated in six completed clinical studies,
which enrolled more than 260 subjects. To date, no serious
adverse events (SAEs) have been observed in subjects receiving
VK2809, and overall tolerability remains encouraging. In
addition, the compound has been evaluated in chronic toxicity
studies of up to 12 months in duration.
The IND for the VOYAGE study included results from the
previously reported 12-week Phase 2 study of VK2809 in subjects
with hypercholesterolemia and NAFLD, as well as prior Phase 1
single and multiple-ascending dose studies in healthy volunteers
and subjects with mild hypercholesterolemia, respectively.
The filing also included results from additional clinical and
non-clinical studies.
New studies submitted with the IND, not previously reported,
include:
- VK2809-106: A Phase 1 study to evaluate the safety,
tolerability, and pharmacokinetics of VK2809 when co-administered
with atorvastatin. These data confirmed previously reported results
demonstrating no meaningful interaction between VK2809 and
atorvastatin when co-administered.
- VK2809-105: A Phase 1 study to evaluate the safety,
tolerability, and pharmacokinetics of VK2809 dosed in an
every-other-day (QOD) regimen. These data confirmed previously
reported results demonstrating that VK2809 possesses a predictable
and consistent PK profile.
- VK2809-103: A Phase 1 study to evaluate the safety,
tolerability, pharmacokinetics, and pharmacodynamics of VK2809 in
various dosing regimens. These data demonstrated that various
alternative dosing regimens may also produce improvement in
measures of plasma lipids.
- 26-Week GLP chronic toxicity studies of VK2809 in primates and
rodents, as well as a separate four-week GLP toxicity study of
VK2809 co-administered with atorvastatin in primates.
The results of the completed VK2809 studies form the basis for
enrollment of the intended target population in the VOYAGE
study. Select data from these studies may be submitted for
presentation at future scientific conferences.
Viking previously announced positive results from a 12-week
Phase 2 trial of VK2809 in patients with hypercholesterolemia and
NAFLD, which achieved both its primary and secondary endpoints,
demonstrating potent reductions in liver fat content and plasma
lipids. Key results from the Phase 2 trial data showed that
88% of patients receiving VK2809 experienced ≥ 30% reduction in
liver fat content at 12 weeks, including all patients receiving 5
mg daily doses. In addition, patients receiving VK2809
experienced improvements in low-density lipoprotein cholesterol
(LDL-C), triglycerides and atherogenic proteins. VK2809 was
shown to be safe and well tolerated in this study, with no SAEs
reported in any cohort.
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 is currently being evaluated in a
Phase 2b clinical trial in
patients with biopsy-confirmed non-alcoholic steatohepatitis
(NASH). VK2809 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 compound 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 is a clinical-stage biopharmaceutical
company focused on the development of novel, orally available,
first-in-class or best-in-class therapies for the treatment of
metabolic and endocrine disorders. Viking'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
novel, orally available, small molecule selective thyroid hormone
receptor beta agonist for the treatment of lipid and metabolic
disorders, including NASH. In a Phase 2 trial for the
treatment of NAFLD and elevated LDL-C, patients who received VK2809
demonstrated statistically significant reductions in LDL-C and
liver fat content compared with patients who received
placebo. The company is also developing VK0214, a novel,
orally available, small molecule selective thyroid hormone receptor
beta agonist for the treatment of X-linked adrenoleukodystrophy
(X-ALD).
Viking's other programs include 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 with patients who received
placebo. Other programs also include VK0612, a
first-in-class, orally available drug candidate in Phase 2
development for the treatment of type 2 diabetes as well as two
earlier-stage programs targeting metabolic diseases and
anemia. The company holds exclusive worldwide rights to a
portfolio of five therapeutic programs, including those noted
above, which are based on small molecules licensed from Ligand
Pharmaceuticals Incorporated.
Follow Viking on Twitter @Viking_VKTX.
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 VK2809 and VK0214; 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, 2018, 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.