SAN DIEGO, April 4, 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
that data from the company's 12-week Phase 2 study of VK2809 in
patients with non-alcoholic fatty liver disease (NAFLD) and
elevated low-density lipoprotein cholesterol (LDL-C) will be
presented at the International Liver Congress™
2019. The study results will be presented in the late-breaker
poster session of the annual meeting of the European Association
for the Study of the Liver (EASL), being held April 10-14 in Vienna,
Austria.
As previously reported, the Phase 2 study successfully achieved
both its primary and secondary endpoints, and demonstrated an
encouraging safety and tolerability profile for VK2089, Viking's
novel liver-selective thyroid receptor beta agonist. The
International Liver Congress presentation will include new data
from the trial's low-dose 5 mg cohort treatment arm, which
demonstrated statistically significant reductions in liver fat
content relative to placebo, as well as statistically significant
response rates, defined by the proportion of patients experiencing
at least a 30% or 50% relative reduction in liver fat, compared
with placebo. Consistent with prior data from the 10 mg
cohorts, VK2809 was well tolerated when dosed at 5 mg daily, and no
serious adverse events were reported among patients receiving
either VK2809 or placebo.
Details of the presentation are as follows:
VK2809, a Novel Liver-Directed Thyroid Receptor Beta Agonist,
Significantly Reduces Liver Fat with Both Low and High Doses in
Patients with Non-Alcoholic Fatty Liver Disease: A Phase 2
Randomized, Placebo-Controlled Trial
- Late-Breaker Poster Number: LBP-20
- Date/time: Thursday, April 11,
2019, 9:00 a.m. – 5:00 p.m. Local Time (CET)
- Session: Late-Breaker Poster – General Hepatology
- Location: Poster Area
- Presenter: Rohit Loomba, M.D., MHSc, Director, NAFLD Research
Center, and Professor of Medicine, University
of California at San Diego
Based on the positive results of this Phase 2 trial, Viking is
currently preparing to initiate a Phase 2b study of VK2809 in biopsy-confirmed
non-alcoholic steatohepatitis (NASH), which is anticipated to begin
in the second half of 2019.
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).
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 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 non-alcoholic steatohepatitis (NASH). In
a Phase 2 trial for the treatment of non-alcoholic fatty liver
disease (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 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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