Wave Life Sciences announced WVE-007, an siRNA treatment for obesity aimed at silencing INHBE to promote sustainable weight loss.
Quiver AI Summary
Wave Life Sciences has announced the submission of a clinical trial application for WVE-007, a new investigational treatment for obesity that targets the INHBE gene to promote fat burning while preserving muscle mass. This approach integrates advanced GalNAc-conjugated small interfering RNA (siRNA) technology and is anticipated to allow for administration just once or twice a year. The company plans to initiate a first-in-human study in early 2025, evaluating safety and metabolic effects in adults with obesity. Preclinical results suggest WVE-007 could lead to similar or greater weight loss compared to existing treatments, including semaglutide, without muscle loss. This novel therapeutic strategy represents a potential advancement in the management of obesity and its associated health risks.
Potential Positives
- WVE-007 represents Wave's first siRNA program to enter clinical development, showcasing the company's innovation and commitment to advancing RNA-based therapies.
- The investigational treatment demonstrates potential for healthy, sustainable weight loss without muscle loss, which distinguishes it from existing obesity therapies.
- Preclinical studies indicate that WVE-007 can lead to significant weight loss comparable to established treatments like semaglutide, with added benefits when used in combination.
- Wave expects to initiate its first-in-human study in 1Q 2025, signaling a critical step forward in the development of this promising obesity treatment.
Potential Negatives
- Wave Life Sciences is entering a highly competitive field of obesity treatment, and its success relies significantly on the outcomes of the upcoming clinical trials for WVE-007, which introduces substantial uncertainty over future profitability and market acceptance.
- The press release heavily emphasizes forward-looking statements, indicating the inherent risks and uncertainties associated with WVE-007, which could result in failure to meet expectations or project timelines.
- The reliance on preclinical mouse models for efficacy data may raise concerns about the translatability of results to human subjects, creating skepticism about the viability of WVE-007 as a treatment option.
FAQ
What is WVE-007?
WVE-007 is a novel siRNA designed to silence the INHBE gene to promote fat burning and sustainable weight loss.
When will the WVE-007 clinical trial begin?
The first-in-human study of WVE-007 is expected to begin in the first quarter of 2025.
How does WVE-007 work for obesity treatment?
WVE-007 silences the INHBE gene, inducing fat burning while maintaining muscle mass, leading to healthier weight loss.
What are the expected benefits of WVE-007?
WVE-007 may enable significant weight loss through fat burning without muscle loss, with potential annual dosing.
What clinical results have been seen with WVE-007 in preclinical studies?
Preclinical studies in mice showed WVE-007 induced weight loss comparable to semaglutide, without muscle loss, and prevented weight regain.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$WVE Insider Trading Activity
$WVE insiders have traded $WVE stock on the open market 11 times in the past 6 months. Of those trades, 1 have been purchases and 10 have been sales.
Here’s a breakdown of recent trading of $WVE stock by insiders over the last 6 months:
- PAUL BOLNO (President and CEO) has traded it 4 times. They made 0 purchases and 4 sales, selling 240,074 shares.
- CHRIS FRANCIS (See Remarks) has traded it 5 times. They made 0 purchases and 5 sales, selling 244,836 shares.
- PLC GSK purchased 2,791,930 shares.
- KYLE MORAN (Chief Financial Officer) sold 17,146 shares.
To track insider transactions, check out Quiver Quantitative's insider trading dashboard.
$WVE Hedge Fund Activity
We have seen 92 institutional investors add shares of $WVE stock to their portfolio, and 70 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- DRIEHAUS CAPITAL MANAGEMENT LLC added 4,950,764 shares (+545.2%) to their portfolio in Q3 2024
- ARTAL GROUP S.A. removed 4,566,251 shares (-100.0%) from their portfolio in Q3 2024
- ADAGE CAPITAL PARTNERS GP, L.L.C. added 4,345,632 shares (+81.1%) to their portfolio in Q3 2024
- MAVERICK CAPITAL LTD added 2,378,159 shares (+31.0%) to their portfolio in Q3 2024
- ARTISAN PARTNERS LIMITED PARTNERSHIP added 1,960,470 shares (+inf%) to their portfolio in Q3 2024
- PRICE T ROWE ASSOCIATES INC /MD/ added 1,687,333 shares (+117.2%) to their portfolio in Q3 2024
- 683 CAPITAL MANAGEMENT, LLC removed 1,125,000 shares (-21.1%) from their portfolio in Q3 2024
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.
Full Release
WVE-007 is a novel approach for treating obesity and is designed to silence INHBE to achieve healthy, sustainable weight loss through fat burning, muscle maintenance and the potential for once or twice-annual administration
WVE-007 is Wave’s first siRNA program to enter clinical development and uses best-in-class oligonucleotide chemistry and GalNAc delivery
Wave expects to initiate the first-in-human study of WVE-007 in 1Q 2025
CAMBRIDGE, Mass., Dec. 23, 2024 (GLOBE NEWSWIRE) -- 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 Sciences
Wave 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 Statements
This 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
+1 617-949-4827
krausch@wavelifesci.com
Media Contact:
Alicia Suter
+1 617-949-4817
asuter@wavelifesci.com
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