Expands Potential Opportunities for VK2735
with Highly Differentiated Dosing Option
Data Anticipated in 2H2023
SAN
DIEGO, March 28, 2023 /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 it has initiated a Phase 1 clinical study to evaluate a novel
oral formulation of the company's dual glucagon-like peptide 1
(GLP-1) and glucose-dependent insulinotropic polypeptide (GIP)
receptor agonist VK2735. The study, which is an extension of the
company's recently completed Phase 1 evaluation of subcutaneously
administered VK2735, will evaluate daily oral doses for 28 days.
The company believes the results from this study could be available
in the second half of 2023.
The Phase 1 trial is a randomized, double-blind,
placebo-controlled study in healthy adults with a minimum body mass
index (BMI) of 30 kg/m2. The primary objective of the
study is to evaluate the safety and tolerability of VK2735
administered as an oral tablet once daily for 28 days. The
secondary objective is to evaluate the pharmacokinetics of orally
administered VK2735 in healthy subjects. Exploratory
pharmacodynamic measures include assessments of changes in body
weight and plasma glucose.
"We are excited to announce the initiation of a clinical study
with oral VK2735. The injectable formulation has shown great
promise in Phase 1 trial results announced earlier today, and we
believe our novel tablet formulation represents a significant
expansion of the program's overall potential," said Brian Lian, Ph.D., chief executive officer of
Viking. "In vivo data to date suggest therapeutic plasma levels of
VK2735 may be achieved via oral dosing, and we expect both the
subcutaneous formulation and the oral formulation to provide unique
benefits to patients. The ability to select either subcutaneous or
oral dosage forms of VK2735 creates attractive potential treatment
options and further extends the reach of this important
program."
Earlier today, Viking reported results from a 28-day multiple
ascending dose Phase 1 study of VK2735 administered subcutaneously,
which demonstrated encouraging tolerability and positive signs of
clinical activity. All cohorts receiving VK2735 demonstrated
reductions in mean body weight from baseline, ranging up to 7.8%.
The company plans to initiate a Phase 2 study of the subcutaneous
formulation of VK2735 in patients with obesity in mid-2023.
About GLP-1 and Dual GLP-1/GIP Agonists
Activation of the glucagon-like peptide 1 (GLP-1) receptor has
been shown to decrease glucose, reduce appetite, lower body weight,
and improve insulin sensitivity in patients with type 2 diabetes,
obesity, or both. Semaglutide is a GLP-1 receptor agonist that has
been approved by the U.S. Food and Drug Administration and is
currently marketed in various dosage strengths and forms as
Ozempic®, Rybelsus®, and Wegovy®.
More recently, research efforts have explored the potential
co-activation of the glucose-dependent insulinotropic peptide (GIP)
receptor as a means of enhancing the therapeutic benefits of GLP-1
receptor activation. Tirzepatide is a dual GLP-1/GIP receptor
agonist that is approved by the U.S. Food and Drug Administration
and is currently marketed as Mounjaro™.
About Viking Therapeutics, Inc.
Viking Therapeutics is a clinical-stage biopharmaceutical
company focused on the development of novel first-in-class or
best-in-class therapies for the treatment of metabolic and
endocrine disorders, with three compounds currently in clinical
trials. 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 2a 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 VK2735, a
novel dual agonist of the glucagon-like peptide 1 (GLP-1) and
glucose-dependent insulinotropic polypeptide (GIP) receptors for
the potential treatment of various metabolic disorders. VK2735 is
currently being evaluated in a Phase 1 clinical trial. In the rare
disease space, the company is developing VK0214, a novel, orally
available, small molecule selective thyroid hormone receptor beta
agonist for the potential treatment of X-linked
adrenoleukodystrophy (X-ALD). VK0214 is currently being
evaluated in a Phase 1b clinical trial in patients with
the adrenomyeloneuropathy (AMN) form of X-ALD. The company holds
exclusive worldwide rights to a portfolio of five therapeutic
programs, including VK2809 and VK0214, 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 its preclinical programs,
including those targeting incretin receptor agonists, and their
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 VK2735, VK0214,
VK2809, and the company's other incretin receptor agonists; 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, 2022, 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.