Wave Life Sciences Announces Submission of First Clinical Trial Application for WVE-007 (siRNA Targeting INHBE) in Obesity
23 Dicembre 2024 - 2:30PM
Wave Life Sciences Ltd. (Nasdaq: WVE), a clinical-stage
biotechnology company focused on unlocking the broad potential of
RNA medicines to transform human health, today announced the
submission of its first clinical trial application (CTA) for
WVE-007 in obesity. WVE-007 is an investigational GalNAc-conjugated
small interfering RNA (siRNA) designed to silence Inhibin βE
(INHBE) gene expression, which would induce fat burning (lipolysis)
to decrease body weight without impacting muscle mass. Wave expects
CTA approval and initiation of the first-in-human study of WVE-007
in the first quarter of 2025.
“Our WVE-007 program, which uses Wave’s best-in-class
GalNAc-siRNA capabilities with proprietary chemistry, has potential
to be dosed once or twice annually and may ultimately be used
across the obesity treatment continuum for sustainable weight loss
and cardiometabolic risk reduction,” said Paul Bolno, MD, MBA,
President and Chief Executive Officer at Wave Life Sciences. “With
a growing understanding of human genetics and opportunities to
directly impact adipose tissue, INHBE has emerged as an exciting,
novel therapeutic target to address obesity, without the challenges
of current standard-of-care therapeutics.”
Human genetics provide strong evidence for INHBE as a
therapeutic target. Individuals who have a protective
loss-of-function mutation in the INHBE gene have a healthier
cardiometabolic profile, including less abdominal fat, lower
triglycerides, and lower risk of type 2 diabetes and cardiovascular
disease. WVE-007 is designed to induce this healthy phenotype
through INHBE gene silencing, leading to fat burning and
improvements in metabolic health. In preclinical studies using a
mouse model of diet induced obesity (DIO), a single dose of Wave’s
INHBE siRNA led to weight loss on par with semaglutide, with no
muscle loss. When administered as an add-on to semaglutide, a
single dose doubled the amount of weight loss. In another study,
Wave’s INHBE siRNA also prevented weight regain when semaglutide
treatment was discontinued.
Wave’s first-in-human study of WVE-007 is a Phase 1 clinical
trial in adults living with overweight or obesity. The trial is
designed to assess safety, tolerability, pharmacokinetics, and
biomarkers for target engagement, as well as body composition and
metabolic health.
About Wave Life SciencesWave Life Sciences
(Nasdaq: WVE) is a biotechnology company focused on unlocking the
broad potential of RNA medicines to transform human health. Wave’s
RNA medicines platform, PRISM®, combines multiple modalities,
chemistry innovation and deep insights in human genetics to deliver
scientific breakthroughs that treat both rare and prevalent
disorders. Its toolkit of RNA-targeting modalities includes
editing, splicing, RNA interference and antisense silencing,
providing Wave with unmatched capabilities for designing and
sustainably delivering candidates that optimally address disease
biology. Wave’s diversified pipeline includes clinical programs in
Duchenne muscular dystrophy, Alpha-1 antitrypsin deficiency and
Huntington’s disease, as well as a preclinical program in obesity.
Driven by the calling to “Reimagine Possible”, Wave is leading the
charge toward a world in which human potential is no longer
hindered by the burden of disease. Wave is headquartered in
Cambridge, MA. For more information on Wave’s science, pipeline and
people, please visit www.wavelifesciences.com and follow Wave on X
(formerly Twitter) and LinkedIn.
Forward-Looking StatementsThis press release
contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995, as amended,
including, without limitation, our expectations for WVE-007, our
investigational GalNAc-conjugated small interfering RNA (siRNA)
designed to silence Inhibin βE (INHBE) gene expression and the
anticipated therapeutic benefits thereof, including the potential
of WVE-007 to treat obesity; the anticipated timing to initiate the
first-in-human clinical program with WVE-007; the novelty of our
approach to silence INHBE in order to achieve healthy, sustainable
weight loss through fat burning, muscle maintenance and the
potential for once or twice-annual dosing; and the potential
benefits of WVE-007 compared with other investigational obesity
treatments and current standard-of-care obesity therapeutics. The
words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,”
“anticipate,” “intend,” “believe,” “estimate,” “predict,”
“project,” “potential,” “continue,” “target” and similar
expressions are intended to identify forward-looking statements,
although not all forward-looking statements contain these
identifying words. Any forward-looking statements in this press
release are based on management's current expectations and beliefs
and are subject to a number of risks, uncertainties and important
factors that may cause actual events or results to differ
materially from those expressed or implied by any forward-looking
statements contained in this press release and actual results may
differ materially from those indicated by these forward-looking
statements as a result of these risks, uncertainties and important
factors, including, without limitation, the risks and uncertainties
described in the section entitled “Risk Factors” in Wave’s most
recent Annual Report on Form 10-K filed with the Securities
and Exchange Commission (SEC), as amended, and in other
filings Wave makes with the SEC from time to time. Wave
undertakes no obligation to update the information contained in
this press release to reflect subsequently occurring events or
circumstances.
Investor Contact:Kate Rausch+1
617-949-4827krausch@wavelifesci.com
Media Contact:Alicia Suter+1
617-949-4817asuter@wavelifesci.com
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