Wave Life Sciences Announces Submission of First Clinical Trial Application for WVE-007 (siRNA Targeting INHBE) in Obesity

Core Insights - Wave Life Sciences Ltd. has submitted its first clinical trial application (CTA) for WVE-007, an investigational GalNAc-conjugated small interfering RNA (siRNA) aimed at treating obesity by silencing the INHBE gene [4] - The company anticipates approval of the CTA and initiation of the first-in-human study in the first quarter of 2025 [4][8] - WVE-007 is designed to promote fat burning while preserving muscle mass, with the potential for once or twice-annual dosing [5][8] Company Overview - Wave Life Sciences is a clinical-stage biotechnology company focused on RNA medicines, utilizing its PRISM® platform to develop treatments for various disorders [7] - The company’s pipeline includes clinical programs targeting Duchenne muscular dystrophy, Alpha-1 antitrypsin deficiency, and Huntington's disease, alongside a preclinical program in obesity [7] Product Details - WVE-007 aims to induce a healthy metabolic profile by silencing the INHBE gene, which has shown promising results in preclinical studies, including weight loss comparable to semaglutide without muscle loss [5][6] - In preclinical trials, a single dose of WVE-007 led to significant weight loss and prevented weight regain when combined with semaglutide [5] Clinical Trial Information - The first-in-human study of WVE-007 will be a Phase 1 clinical trial focusing on safety, tolerability, pharmacokinetics, and metabolic health in adults with overweight or obesity [6]