13-Week Study to Evaluate the Safety and
Efficacy of VK2735 Dosed Weekly
Trial Size Increased from 125 to 176 Patients
Due to Elevated Demand
SAN
DIEGO, Oct. 23, 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 completion of patient enrollment in its 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. Viking expects to report data from the
study in the first half of 2024.
The Phase 2 VENTURE trial is a randomized, double-blind,
placebo-controlled study intended to evaluate the safety,
tolerability, pharmacokinetics, and weight loss efficacy of VK2735,
administered subcutaneously, once weekly. The 13-week trial was
designed to 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 comorbid
condition. Due to heightened clinician and patient interest, the
trial's enrollment size was increased to 176 from the original
target. The primary endpoint of the study will assess the percent
change in body weight from baseline to Week 13 among patients
treated with VK2735 as compared with placebo, with secondary and
exploratory endpoints evaluating a range of additional safety and
efficacy measures. The VENTURE trial will evaluate weekly VK2735
doses of up to 15 mg, compared to the 10 mg top dose evaluated in
the prior Phase 1 multiple ascending dose (MAD) study.
"The high level of interest in this trial allowed us to not only
enroll the study more rapidly than anticipated, but to
significantly exceed our original enrollment target. This speaks
both to the continued unmet needs of patients with obesity, and the
promise demonstrated by the encouraging Phase 1 study data from
VK2735 reported earlier this year," said Brian Lian, Ph.D., chief executive officer of
Viking. "We look forward to reporting the results from this
important study in the first half of 2024."
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.
These results were featured earlier this month in an oral
presentation at ObesityWeek® 2023, the
annual meeting of the Obesity Society. The presentation highlighted
the previously-reported safety, tolerability, and weight loss
findings, as well as new data demonstrating VK2735's impact on
liver fat and plasma lipids. Notably, after four weekly doses of
VK2735, subjects in the Phase 1 trial reported liver fat reductions
of up to 47% from baseline (placebo-adjusted, p<0.01).
Among subjects with non-alcoholic fatty liver disease (NAFLD),
placebo-adjusted reductions in liver fat reached approximately 59%
(p<0.01). Though limited in sample size, these results may
indicate VK2735's potential benefit in patients with various forms
of fatty liver disease.
The ObesityWeek presentation also highlighted VK2735's effects
on plasma lipids. Despite normal baseline plasma lipid levels among
these healthy volunteers, treatment with VK2735 produced
encouraging reductions from baseline in total cholesterol (up to
21%), low-density lipoprotein cholesterol (LDL-C; up to 23%), and
apolipoprotein B [Apo(B); up to 21%].
The majority of observed adverse events (98%) in the Phase 1
trial were reported as mild or moderate. The company believes that
the tolerability data from the Phase 1 study indicate that higher
doses may be achieved with longer titration windows.
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.
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