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, MA, USA I February 06, 2025 I 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 Assessments of healthy weight loss, or fat loss with lean mass preservation, are consistent with recently issued FDA draft guidance on developing therapeutics for weight reduction.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.
SOURCE: Wave Life Sciences
Post Views: 128
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, MA, USA I February 06, 2025 I 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.
SOURCE: Wave Life Sciences
Post Views: 128
