SAN DIEGO, Aug. 20, 2020 /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 Digital International Liver Congress™
2020. The study results will be featured in an oral
presentation at the annual meeting of the European Association for
the Study of the Liver (EASL), being held virtually August 27-29, 2020.
As previously reported, the Phase 2 study of VK2089, Viking's
novel liver-selective thyroid receptor beta agonist, successfully
achieved both its primary and secondary efficacy endpoints,
demonstrating median relative reductions in liver fat ranging from
53.8% to approximately 60%, and response rates of up to 100%, both
of which represent unprecedented efficacy from an oral agent.
The Digital International Liver Congress presentation will include
new efficacy data measured at Week 16, four weeks following the
completion of treatment. Additional new data will be reported
on 12-week efficacy results stratified by baseline patient
characteristics and known disease risk factors.
Details of the presentation are as follows:
VK2809, a Novel Liver-Directed Thyroid Receptor Agonist,
Produces Durable Reductions in Liver Fat in Patients with
Non-Alcoholic Fatty Liver Disease: Results of 4-Week Follow-Up
Assessment from a 12-Week Phase 2 Randomized, Placebo-Controlled
Trial
- Presentation Number: AS073
- Date/time: Friday, August 28,
2020, 6:00 – 6:15 a.m.
EST
- Session: NAFLD – Pharmacological Therapy
- Presenter: Rohit Loomba, M.D.,
MHSc, Director, NAFLD Research Center, and Professor of Medicine,
University of California at San
Diego
Viking is currently evaluating VK2809 in the Phase 2b VOYAGE study in patients with
biopsy-confirmed non-alcoholic steatohepatitis (NASH) and
fibrosis.
About VK2809
VK2809 is an orally available small molecule agonist of the
thyroid hormone receptor that possesses selectivity for liver
tissue, as well as the beta receptor subtype, and has demonstrated
promising therapeutic potential in a range of lipid disorders,
including NASH. In 2019, the company initiated the Phase
2b VOYAGE trial. This trial is
a randomized, double-blind, placebo-controlled, multicenter study
designed to assess the efficacy, safety and tolerability of VK2809
in patients with biopsy-confirmed NASH and fibrosis ranging from
stages F1 to F3. The study is targeting enrollment of
approximately 340 patients across five treatment arms: 1.0 mg
daily; 2.5 mg daily; 5.0 mg every other day; 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. U.S. enrollment is continuing and we remain on
schedule to begin opening ex-U.S. sites during the third quarter of
2020.
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, which is currently being evaluated in a
Phase 2b study for the treatment of biopsy-confirmed
non-alcoholic steatohepatitis (NASH) and fibrosis. 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.
For more information about Viking Therapeutics, please visit
www.vikingtherapeutics.com. 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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SOURCE Viking Therapeutics, Inc.