13-Week Study to Evaluate the Safety and
Efficacy of VK2735 Dosed Weekly
SAN
DIEGO, Sept. 6, 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
the initiation of a Phase 2 clinical trial of VK2735, the company's
wholly-owned dual agonist of the glucagon-like peptide 1 (GLP-1)
and glucose-dependent insulinotropic polypeptide (GIP) receptors.
VK2735 is in development for the potential treatment of
various metabolic disorders such as obesity.
The Phase 2 VENTURE trial is a randomized, double-blind,
placebo-controlled study that will evaluate the safety,
tolerability, pharmacokinetics, and weight loss efficacy of four
different doses of VK2735, administered subcutaneously, once
weekly. The 13-week trial will enroll approximately 125
adults who are obese (BMI ≥30 kg/m2), or adults who are
overweight (BMI ≥27 kg/m2) with at least one
weight-related co-morbid condition. The primary endpoint of
the study is the percent change in body weight from baseline to
Week 13, with secondary and exploratory endpoints evaluating a
range of additional safety and efficacy measures.
"We are excited to announce the initiation of the VENTURE study,
which will build upon the promising VK2735 Phase 1 data we reported
earlier this year," said Brian Lian,
Ph.D., chief executive officer of Viking. "Obesity is a major
healthcare challenge, and recent data confirm that effective weight
loss agents can reduce a patient's cardiovascular risk profile,
providing important health benefits. We look forward to
exploring VK2735's safety and weight loss efficacy over this
study's 13-week dosing window."
Viking previously reported positive results from a Phase 1
single ascending dose (SAD) and multiple ascending dose (MAD)
clinical trial of VK2735 in healthy volunteers with a BMI
≥30. In the SAD portion of the study, VK2735 demonstrated
promising safety and tolerability, as well as a predictable
pharmacokinetic profile. In the 28-day MAD portion of the
study, VK2735 was well-tolerated and showed positive signs of
clinical activity. All MAD cohorts receiving VK2735
experienced reductions in mean body weight from baseline, ranging
up to 7.8%. Cohorts receiving VK2735 also demonstrated
reductions in mean body weight relative to placebo, ranging up to
6.0%. Statistically significant differences compared to
placebo were maintained or improved at the Day 43 follow-up time
point, 21 days after the last dose of VK2735 was
administered.
The majority of observed adverse events (98%) in the Phase 1
trial were reported as mild or moderate. The majority of
GI-specific adverse events (99%) were also reported as mild or
moderate. Notably, despite robust activation of the incretin
receptor pathways, no hypoglycemia was reported. The company
believes that the tolerability data from the Phase 1 study indicate
that higher doses may be achieved with longer titration
windows.
Viking is also conducting a Phase 1 trial of a novel oral
formulation of VK2735, which it believes may significantly expand
the market opportunity for the compound by offering patients the
option between subcutaneous and oral dosages forms. The
company expects to report initial data from the oral formulation
Phase 1 study in the fourth quarter of 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 currently in clinical development for obesity.
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. Data from a Phase 1 trial
evaluating VK2735 (dosed subcutaneously) for metabolic disorders
demonstrated an encouraging safety and tolerability profile as well
as positive signs of clinical benefit. The company also recently
initiated a Phase 1 study to evaluate an oral formulation of
VK2735. 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 clinical and preclinical development programs and cash
resources. 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.