Innovent Completes Initial Dosing in Phase 3 Mazdutide Trial in China

Innovent Biologics, Inc., a prominent biopharmaceutical company, announced a significant advancement in their Phase 3 clinical trial of mazdutide, targeting obstructive sleep apnea (OSA) in obese Chinese participants. This development marks the beginning of the seventh Phase 3 trial for mazdutide, aimed at further exploring its efficacy in treating obesity and related metabolic conditions.

The GLORY-OSA trial is a comprehensive, multicenter study evaluating the effectiveness and safety of mazdutide, a dual receptor agonist, compared to a placebo in Chinese individuals suffering from moderate-to-severe OSA and obesity. The study's main goal is to observe changes in the apnea-hypopnea index over 48 weeks.

Globally, OSA affects approximately 425 million people aged 30 to 69, with China experiencing a substantial burden, having around 66 million cases. Despite the high prevalence, diagnosis rates are notably low, especially in China, where less than 1% of cases are diagnosed. Obesity significantly increases the risk of developing OSA, affecting a large portion of individuals with the condition.

Positive airway pressure (PAP) remains the primary treatment for OSA, offering substantial benefits to some patients. However, many struggle with the demands of this therapy, and evidence linking PAP to improved cardiometabolic outcomes is weak. Recently, the FDA approved Zepbound® in the US, a dual receptor agonist for OSA treatment in obese adults, yet no such treatment is approved in China, indicating a crucial unmet need.

Research suggests that weight reduction can significantly decrease the severity of OSA, highlighting the potential role of weight loss medications in its treatment. Innovent's mazdutide is positioned as a promising candidate, offering potential benefits in managing OSA and obesity with its unique dual agonist mechanism.

Professor Tianpei Hong, leading the study at Peking University Third Hospital, emphasized the heightened risks and diminished quality of life faced by untreated OSA patients. He noted the growing prevalence of OSA among obese individuals and the absence of effective drug treatments in China. In a prior Phase 3 study, mazdutide demonstrated significant weight loss and metabolic improvements, presenting a well-tolerated safety profile. He expressed commitment to collaborating with the GLORY-OSA team to ensure the study's success and expand treatment options for affected patients.

Dr. Lei Qian, Senior Vice President of Clinical Development at Innovent, highlighted the tailored development approach of mazdutide to address diverse patient needs. In a Phase 2 trial, mazdutide showed notable weight loss and cardiovascular benefits compared to a placebo. The ongoing GLORY-OSA study aims to further establish its efficacy and safety, potentially offering a pharmacologic alternative to PAP therapy.

Mazdutide, developed under an exclusive agreement with Eli Lilly, is a dual receptor agonist designed to offer benefits beyond traditional GLP-1 receptor agonists. It promotes insulin secretion, improves glucose control, and enhances energy expenditure, among other metabolic advantages. The drug has demonstrated effectiveness in weight reduction and improved metabolic markers in clinical trials.

Currently, mazdutide is under review for long-term weight management and glycemic control in adults. It is involved in seven Phase 3 trials addressing various conditions, including obesity, OSA, and type 2 diabetes. Some trials have already met their primary endpoints, while others continue to provide valuable insights into mazdutide's multifaceted benefits.

Innovent Biologics, founded in 2011, is dedicated to developing innovative treatments for challenging diseases, with a strong focus on cancer, cardiovascular, and metabolic disorders. The company maintains a robust pipeline of products and collaborations with leading global healthcare entities, emphasizing integrity and action in its operations to make high-quality pharmaceuticals widely accessible.