Wave Life Sciences Announces Initiation of Phase 1 INLIGHT Clinical Trial of WVE-007 in Obesity
Wave Life Sciences (WVE) has initiated the Phase 1 INLIGHT clinical trial for WVE-007, a novel obesity treatment targeting INHBE mRNA. The trial follows CTA approval and represents Wave's first siRNA to enter clinical development. WVE-007 is designed as a long-acting GalNAc-siRNA treatment with potential once- or twice-yearly dosing, aiming to achieve healthy weight loss by reducing fat while preserving muscle mass.
The INLIGHT trial will evaluate safety, tolerability, pharmacokinetics, and biomarkers in adults with overweight or obesity, focusing on body weight, composition, and metabolic health outcomes. The company expects to deliver proof-of-concept clinical data in 2025, aligning with FDA draft guidance on weight reduction therapeutics.
Wave Life Sciences (WVE) ha avviato la fase 1 dello studio clinico INLIGHT per WVE-007, un trattamento innovativo per l'obesità che mira all'mRNA di INHBE. Lo studio segue l'approvazione della CTA e rappresenta il primo siRNA di Wave ad entrare nello sviluppo clinico. WVE-007 è progettato come un trattamento GalNAc-siRNA a lunga durata d'azione, con potenziali somministrazioni una o due volte all'anno, con l'obiettivo di ottenere una perdita di peso sana riducendo il grasso e preservando la massa muscolare.
Lo studio INLIGHT valuterà la sicurezza, la tollerabilità, la farmacocinetica e i biomarcatori in adulti in sovrappeso o obesi, concentrandosi sui risultati riguardanti il peso corporeo, la composizione e la salute metabolica. L'azienda prevede di fornire dati clinici di prova di concetto nel 2025, in linea con le linee guida provvisorie della FDA sui farmaci per la riduzione del peso.
Wave Life Sciences (WVE) ha iniciado el ensayo clínico INLIGHT de Fase 1 para WVE-007, un nuevo tratamiento para la obesidad que se dirige al mRNA de INHBE. El ensayo sigue la aprobación de la CTA y representa el primer siRNA de Wave en entrar en desarrollo clínico. WVE-007 está diseñado como un tratamiento GalNAc-siRNA de acción prolongada, con posibles dosis una o dos veces al año, con el objetivo de lograr una pérdida de peso saludable reduciendo el tejido graso mientras se preserva la masa muscular.
El ensayo INLIGHT evaluará la seguridad, la tolerabilidad, la farmacocinética y los biomarcadores en adultos con sobrepeso u obesidad, centrándose en el peso corporal, la composición y los resultados de salud metabólica. La empresa espera ofrecer datos clínicos de prueba de concepto en 2025, en línea con las pautas preliminares de la FDA sobre terapias de reducción de peso.
웨이브 라이프 사이언스 (WVE)는 INHBE mRNA를 표적으로 하는 새로운 비만 치료제 WVE-007에 대한 1상 INLIGHT 임상 시험을 시작했습니다. 이 시험은 CTA 승인을 받은 후 진행되며, 웨이브의 첫 번째 siRNA가 임상 개발에 들어가는 것입니다. WVE-007은 지방을 줄이고 근육량을 보존하면서 건강한 체중 감량을 목표로 하는 장시간 작용 GalNAc-siRNA 치료제입니다. 연간 1회 또는 2회 투여가 가능할 것으로 예상됩니다.
INLIGHT 시험은 체중과 구성, 대사 건강 결과에 중점을 두고 과체중 또는 비만 성인에서 안전성, 내약성, 약물 동태학 및 바이오마커를 평가합니다. 이 회사는 2025년에 개념 증명 임상 데이터를 제공할 것으로 예상하고 있으며, 이는 체중 감소 치료에 대한 FDA의 초안 지침에 부합합니다.
Wave Life Sciences (WVE) a lancé l'essai clinique de phase 1 INLIGHT pour WVE-007, un nouveau traitement de l'obésité ciblant l'ARNm INHBE. L'essai suit l'approbation de la CTA et représente le premier siRNA de Wave à entrer dans le développement clinique. WVE-007 est conçu comme un traitement GalNAc-siRNA à action prolongée, avec des doses potentielles une ou deux fois par an, visant à obtenir une perte de poids saine en réduisant la graisse tout en préservant la masse musculaire.
L'essai INLIGHT évaluera la sécurité, la tolérance, la pharmacocinétique et les biomarqueurs chez des adultes en surpoids ou obèses, en mettant l'accent sur le poids corporel, la composition et les résultats de santé métabolique. L'entreprise prévoit de fournir des données cliniques de preuve de concept en 2025, conformément aux lignes directrices provisoires de la FDA sur les traitements de réduction du poids.
Wave Life Sciences (WVE) hat die Phase 1 der INLIGHT-Studie für WVE-007 initiiert, eine neuartige Behandlung von Fettleibigkeit, die auf INHBE-mRNA abzielt. Die Studie folgt der Genehmigung der CTA und stellt die erste siRNA von Wave dar, die in die klinische Entwicklung eintritt. WVE-007 ist als langwirkendes GalNAc-siRNA-Therapeutikum konzipiert, das möglicherweise einmal oder zweimal jährlich verabreicht wird, mit dem Ziel, eine gesunde Gewichtsreduktion zu erreichen, indem Fett abgebaut und gleichzeitig die Muskelmasse erhalten wird.
Die INLIGHT-Studie wird Sicherheit, Verträglichkeit, Pharmakokinetik und Biomarker bei Erwachsenen mit Übergewicht oder Fettleibigkeit bewerten und sich auf Körpergewicht, Körperzusammensetzung und metabolische Gesundheitsergebnisse konzentrieren. Das Unternehmen erwartet, 2025 klinische Proof-of-Concept-Daten bereitzustellen, was mit den vorläufigen FDA-Richtlinien zu therapeutischen Maßnahmen zur Gewichtsreduktion übereinstimmt.
- Novel treatment approach targeting 1 billion+ global obesity market
- Potential for convenient once- or twice-yearly dosing schedule
- First siRNA product entering clinical development
- Trial design aligned with FDA draft guidance
- No clinical efficacy data available until 2025
- Early-stage Phase 1 trial with inherent development risks
- Entering highly competitive obesity treatment market
Insights
The initiation of the INLIGHT Phase 1 trial marks a significant milestone in the obesity treatment landscape. WVE-007's novel approach targeting INHBE mRNA through GalNAc-siRNA technology represents a paradigm shift in obesity treatment for several reasons:
The mechanism of action is particularly noteworthy - by directly targeting fat cells while preserving muscle mass, WVE-007 addresses a critical limitation of current obesity treatments that often result in both fat and muscle loss. This differentiation could provide a competitive advantage in an increasingly crowded market dominated by GLP-1 agonists.
The potential once or twice-yearly dosing schedule is a game-changing feature that could dramatically improve treatment adherence compared to weekly or daily dosing required by current options. This could translate into superior real-world effectiveness and potentially higher market penetration.
The timing of this trial is strategically optimal, as the obesity market is experiencing unprecedented growth and attention from both medical communities and investors. Wave Life Sciences is positioning itself to potentially capture market share in what's projected to be a multi-billion dollar market.
Key catalysts to monitor include:
- Safety and tolerability data from the Phase 1 trial
- Biomarker evidence of target engagement
- Body composition changes demonstrating selective fat loss
- Metabolic health improvements
The alignment with FDA's recent draft guidance on weight reduction therapeutics suggests a well-planned regulatory strategy, potentially streamlining the path to approval if the data proves positive.
WVE-007 is a novel, long-acting GalNAc-siRNA targeting INHBE mRNA – a genetically validated target that provides a new approach for healthy, sustainable weight loss (fat loss with muscle preservation)
Proof-of-concept clinical data from INLIGHT are expected in 2025
CAMBRIDGE, Mass., Feb. 06, 2025 (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 clinical trial application (CTA) approval and initiation of the Phase 1 INLIGHT clinical trial of WVE-007 in obesity. WVE-007 is a long-acting GalNAc-conjugated small interfering RNA (siRNA) that targets INHBE messenger RNA. INHBE is a genetically validated target that provides a novel approach for healthy weight loss. Wave expects to deliver proof-of-concept clinical data in 2025.
“WVE-007 is designed to treat obesity in an entirely new way by directly impacting fat cells to drive weight reduction, maintain muscle mass, and improve cardiometabolic health outcomes. With the potential for once- or twice-yearly dosing, WVE-007 is uniquely positioned to address more than 1 billion people living with obesity globally,” said Paul Bolno, MD, MBA, President and Chief Executive Officer at Wave Life Sciences. “WVE-007 is also Wave’s first siRNA to enter clinical development and utilizes our state-of-the art chemistry delivering potentially best-in-class silencing and durability. We are excited to continue advancing WVE-007 as we enter a new era for RNA interference and its application in common diseases.”
INLIGHT is a Phase 1, first-in-human clinical trial, which is designed to enroll adults living with overweight or obesity and assess safety, tolerability, pharmacokinetics, biomarkers for target engagement, body weight and composition, and metabolic health. Assessments of healthy weight loss, or fat loss with lean mass preservation, are consistent with recently issued FDA draft guidance on developing therapeutics for weight reduction. Proof-of-concept clinical data from INLIGHT, including safety, tolerability, and biomarkers reflective of healthy weight loss, are expected in 2025.
About WVE-007
WVE-007 is a GalNAc-conjugated small interfering RNA (GalNAc-siRNA) that targets inhibin βE (“INHBE”) messenger RNA. INHBE mRNA encodes a protein called Activin E that is secreted from the liver and acts directly on fat cells to block fat burning (“lipolysis”); therefore, silencing of INHBE would restart and maintain lipolysis. Human genetics also provide strong evidence for INHBE as a therapeutic target. Individuals who have a protective loss-of-function mutation in one copy of 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, leading to fat burning, muscle preservation, and improvements in metabolic health. Preclinical data using a mouse model of diet induced obesity (DIO) demonstrate WVE-007’s potential in multiple treatment settings, including as a monotherapy, as an add-on to GLP-1s, and as a maintenance treatment to prevent weight regain upon discontinuation of GLP-1 treatment.
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 common 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 Alpha-1 antitrypsin deficiency, Duchenne muscular dystrophy, Huntington’s disease, and Obesity, as well as several preclinical programs utilizing the company’s broad RNA therapeutics toolkit. 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 of the proof-of-concept data from our INLIGHT clinical trial of WVE-007; the novelty of our approach to silence INHBE in order to achieve healthy, sustainable weight loss and the potential for once- or twice-yearly 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
FAQ
What is the expected timeline for WVE-007's proof-of-concept data?
How frequently will WVE-007 need to be administered for obesity treatment?
What makes WVE-007 different from other obesity treatments?
What will the Phase 1 INLIGHT trial evaluate for WVE-007?
How does WVE-007 align with FDA requirements for obesity treatments?
