Oral Late Breaker Presentation Summarizes
Positive Results Including Successful Achievement of Study's
Primary and Secondary Endpoints
Data Support VK2809's Best-in-Class Profile
Highlighted by Robust Liver Fat Reductions, Histologic Results
Demonstrating NASH/MASH Resolution and Fibrosis Improvement, and
Promising Tolerability and Safety
SAN
DIEGO, Nov. 19, 2024 /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 final results from the company's Phase 2b clinical trial of VK2809, the company's novel
liver-selective thyroid hormone receptor beta agonist, in patients
with biopsy-confirmed non-alcoholic steatohepatitis (NASH; also
referred to as metabolic dysfunction associated steatohepatitis,
MASH) were highlighted in an oral late breaker presentation at the
75th Liver Meeting® 2024, the annual meeting
of the American Association for the Study of Liver Disease
(AASLD). The presentation summarized the final 52-week data
from the VOYAGE study, showing that VK2809 successfully achieved
the trial's primary and secondary endpoints while demonstrating
excellent tolerability and promising safety.
Highlights from the oral presentation included:
Reduction in Liver Fat Content at 52 Weeks
Patients receiving VK2809 demonstrated statistically significant
reductions in liver fat at Week 12, which was the primary endpoint
in VOYAGE. Importantly, patients receiving VK2809 continued
to demonstrate statistically significant reductions in liver fat
content at Week 52, with the mean relative change from baseline
ranging from 37% to 55%. The response rate in this study,
defined as the proportion of patients experiencing reduction in
liver fat ≥30%, ranged from 64% to 88% at Week 52, with all
treatment arms demonstrating statistically significant improvement
compared to placebo.
Histologic Results at 52 Weeks
On the secondary endpoint of NASH resolution with no worsening
of fibrosis, VK2809-treated patients demonstrated NASH resolution
ranging from 63% to 75%, compared with 29% for placebo (p<0.05
for each VK2809 treatment group). Across the combined VK2809
treatment groups, 69% achieved NASH resolution (p<0.0001 vs.
placebo). Resolution of NASH was defined as a non-alcoholic
fatty liver disease activity score (NAS) of 0 or 1 for inflammation
and 0 for ballooning.
On the secondary endpoint evaluating improvement in fibrosis
with no worsening of NASH, VK2809-treated patients demonstrated
improvement in fibrosis ranging from 44% to 57%, compared with 34%
for placebo (p<0.05 for the 5 mg and 10 mg QOD cohorts).
Across the combined VK2809 treatment groups, 51% achieved
improvement in fibrosis with no worsening of NASH (p=0.03 vs.
placebo). Improvement in fibrosis without worsening of NASH
was defined as a ≥1-stage improvement in fibrosis and no increase
in NAS for ballooning, inflammation, or steatosis.
On the secondary endpoint evaluating the proportion of patients
experiencing both resolution of NASH and improvement in fibrosis,
VK2809-treated patients demonstrated improvement ranging from 40%
to 50%, compared with 20% for placebo (p<0.05 for the 5 mg and
10 mg QOD cohorts). Across the combined VK2809 treatment
groups, 44% achieved this endpoint (p=0.003 vs. placebo).
Resolution of NASH and improvement in fibrosis were defined as
described above.
Reduction in Plasma Lipids at Week 52
Patients receiving VK2809 demonstrated placebo-adjusted
reductions in LDL-C ranging from 20% to 25% (p<0.01 for each
arm), as well as reductions in triglycerides and atherogenic
proteins such as apolipoprotein B (ApoB), lipoprotein (a) [Lp(a)],
and apolipoprotein C-III (ApoC-III), all of which have been
correlated with cardiovascular risk. These results support prior
data demonstrating that VK2809 may offer a cardioprotective benefit
through its robust reduction in plasma lipids.
Safety and Tolerability
VK2809 demonstrated encouraging safety and tolerability in this
study through 52 weeks of treatment, with minimal differences
compared with the previously reported results at 12 weeks.
The majority (94%) of treatment related adverse events among
patients receiving VK2809 were reported as mild or moderate.
Discontinuations due to adverse events were low and balanced among
placebo and treatment arms. As in prior studies, and at the
12-week timepoint in this study, VK2809 demonstrated excellent
gastrointestinal (GI) tolerability throughout the 52-week treatment
window in this study. Rates of nausea, diarrhea, stool
frequency, and vomiting were similar among VK2809-treated patients
compared to placebo.
"The final 52-week data from the VOYAGE study provide compelling
evidence of the therapeutic potential of VK2809 in NASH/MASH," said
Rohit Loomba, M.D., MHSc, Chief of
the Division of Gastroenterology and Hepatology and Director of the
MASLD Research Center at University of
California San Diego School of Medicine. "The potent
reductions in liver fat, impressive NASH resolution rates, and
improvements in fibrosis suggest an attractive potential treatment
option for patients. In addition, the observed improvements
in plasma lipids indicate a potential long-term cardioprotective
effect, a valuable benefit in this setting."
Brian Lian, Ph.D., chief
executive officer of Viking, added, "VK2809, along with our ongoing
clinical activities with subcutaneous and oral VK2735 in obesity,
as well as our preclinical program targeting amylin receptor
agonists, provides Viking with one of the industry's most exciting
and complementary therapeutic pipelines in the field of metabolic
disorders. We look forward to continued advancement of our
pipeline programs in important metabolic disorders."
Study Design
The VOYAGE study was a randomized, double-blind,
placebo-controlled, multicenter, international trial designed to
assess the efficacy, safety and tolerability of VK2809 in patients
with biopsy-confirmed NASH/MASH and fibrosis. Enrollment
included patients with at least 8% liver fat content as measured by
MRI-PDFF, as well as F2 and F3 fibrosis. The study allowed
for up to 25% of enrolled patients to have F1 fibrosis provided
they also possessed at least one additional risk factor, such as
diabetes, obesity or hypertension, among others. The primary
endpoint of the study evaluated the change in liver fat content
from baseline to Week 12 in patients treated with VK2809 as
compared to patients receiving placebo. Secondary objectives
include the evaluation of histologic changes assessed by hepatic
biopsy after 52 weeks of treatment.
About VK2809
VK2809 is an orally available, tissue and receptor-subtype
selective agonist of the thyroid hormone 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 Phase 2b VOYAGE study of VK2809 in patients with
biopsy-confirmed non-alcoholic steatohepatitis (NASH; also referred
to as metabolic dysfunction associated steatohepatitis, MASH) and
fibrosis successfully achieved both the trial's primary and
secondary endpoints. VK2809 also successfully achieved primary and
secondary endpoints in a Phase 2a study for the treatment of
patients with elevated LDL-C and non-alcoholic fatty liver disease
(NAFLD). Selective activation of the thyroid hormone beta receptor
in liver tissue is believed to favorably affect cholesterol and
lipoprotein levels via multiple mechanisms, including increasing
the expression of genes associated with lipid metabolism and
clearance.
About Viking Therapeutics, Inc.
Viking Therapeutics, Inc. 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. Viking's clinical
programs include 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 and a Phase 2 trial evaluating
VK2735 (dosed subcutaneously) for metabolic disorders demonstrated
an encouraging safety and tolerability profile as well as positive
signs of clinical benefit. Concurrently, the company is evaluating
an oral formulation of VK2735 in a Phase 1 trial. Viking is also
developing VK2809, a novel, orally available, small molecule
selective thyroid hormone receptor beta agonist for the treatment
of lipid and metabolic disorders. The compound successfully
achieved both the primary and secondary endpoints in a recently
completed Phase 2b study for the treatment of
biopsy-confirmed non-alcoholic steatohepatitis (NASH; also referred
to as metabolic dysfunction associated steatohepatitis, MASH) 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's newest program is
evaluating a series of internally developed dual amylin and
calcitonin receptor agonists (or DACRAs) for the treatment of
obesity and other metabolic disorders. In the rare disease
space, Viking 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). In a Phase 1b clinical trial in patients
with the adrenomyeloneuropathy (AMN) form of X-ALD, VK0214 was
shown to be safe and well-tolerated, while driving significant
reductions in plasma levels of very long-chain fatty acids (VLCFAs)
and other lipids, as compared to placebo.
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, anticipated
timing for reporting clinical data 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, 2023, 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.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/viking-therapeutics-presents-results-from-phase-2b-voyage-study-of-vk2809-in-biopsy-confirmed-nashmash-at-the-75th-liver-meeting-2024-302310271.html
SOURCE Viking Therapeutics, Inc.
