Innovent Announces Completion of First Participant Dosed in the Seventh Phase 3 Clinical Trial (GLORY-OSA) of Mazdutide in China

Core Viewpoint - Innovent Biologics has initiated a Phase 3 clinical trial (GLORY-OSA) for mazdutide, targeting moderate-to-severe obstructive sleep apnea (OSA) and obesity in Chinese participants, marking a significant step in addressing an unmet medical need in this area [1][5]. Company Overview - Innovent Biologics is a biopharmaceutical company focused on developing high-quality medicines for various diseases, including oncology, cardiovascular, metabolic, autoimmune, and ophthalmology [1]. - The company has launched 15 products and has multiple assets in various stages of clinical trials, including 4 in Phase III or pivotal trials and 15 in early clinical stages [8]. Clinical Trial Details - The GLORY-OSA trial is a multicenter, randomized, open-label study comparing mazdutide 9mg to placebo, with the primary endpoint being the change in apnea-hypopnea index (AHI) from baseline to Week 48 [2]. - This trial is the seventh Phase 3 study for mazdutide in China, aimed at generating comprehensive evidence for its efficacy in managing obesity and metabolic syndromes [1][2]. Market Need and Context - Approximately 425 million people globally suffer from moderate-to-severe OSA, with China having around 66 million cases, yet diagnosis rates are critically low [3]. - OSA is particularly prevalent among individuals with obesity, with a 40% prevalence rate, increasing to 80.5% among those undergoing bariatric surgery [3]. Treatment Landscape - Positive airway pressure (PAP) is the first-line treatment for OSA, but many patients struggle with adherence due to its burdensome nature [4]. - There is currently no approved pharmacological treatment for OSA in China, highlighting a significant unmet medical need [4]. Mazdutide's Potential - Mazdutide, a dual glucagon and GLP-1 receptor agonist, has shown promising results in weight loss and cardiovascular benefits, achieving an 18.6% weight loss compared to placebo in a Phase 2 study [5][7]. - The drug may offer additional benefits beyond GLP-1 receptor agonists, such as promoting insulin secretion and improving hepatic fat metabolism [7]. Future Prospects - The GLORY-OSA study aims to validate mazdutide's efficacy and safety, potentially providing a pharmacologic alternative to PAP for patients with moderate-to-severe OSA [5]. - Innovent has plans for further clinical studies of mazdutide, indicating a robust pipeline for addressing obesity and related metabolic disorders [8].