Innovent to Present Mazdutide Clinical Study Results at EASD 2024

6 September 2024

Innovent Biologics, Inc., a globally recognized biopharmaceutical company, announced that several clinical study results for mazdutide, a dual agonist for GLP-1R and GCGR, will be highlighted at the European Association for the Study of Diabetes (EASD) 60th Annual Meeting in Madrid from September 9 to 13, 2024. The presentations will cover various studies, including the late-breaking Phase 3 DREAMS-2 trial and other significant trials related to weight loss and liver health.

The Phase 3 DREAMS-2 study investigated the efficacy of mazdutide compared to dulaglutide in Chinese adults with type 2 diabetes. This 28-week, open-label trial will be presented by Prof. Lixin Guo from Peking Hospital on September 11th. The trial's results indicate that mazdutide provides superior blood sugar control and weight loss compared to dulaglutide.

Another key presentation is the GLORY-1 study focusing on the efficacy and safety of mazdutide in Chinese participants dealing with overweight or obesity. Prof. Linong Ji from Peking University People's Hospital will deliver this presentation on September 12th. Also within the GLORY-1 framework, an exploratory analysis on the improvement of liver steatosis in participants with overweight or obesity will be discussed by Prof. Leili Gao on September 10th.

Additionally, a Phase 2 study on mazdutide's impact on Chinese adults with a Body Mass Index (BMI) of 30 kg/m^2 or higher will be presented by Prof. Hongwei Jiang from the First Affiliated Hospital of Henan University of Science and Technology on September 12th.

Dr. Lei Qian, Vice President of Clinical Development at Innovent, expressed excitement about the results being shared at the EASD meeting. Dr. Qian emphasized that mazdutide is the first GLP-1R/GCGR dual agonist to complete a Phase 3 diabetes study successfully, showcasing significant benefits in blood sugar reduction and weight loss. The drug has also shown consistent efficacy in various weight loss trials, including GLORY-1 and a Phase 2 study, highlighting its potential metabolic benefits, particularly for liver health.

Innovent holds an exclusive license agreement with Eli Lilly and Company for the development and potential commercialization of mazdutide in China. As an oxyntomodulin analogue, mazdutide not only promotes insulin secretion and lowers blood glucose but also aids in weight reduction. It enhances energy expenditure and improves hepatic fat metabolism by activating the glucagon receptor. Clinical trials have consistently demonstrated its effectiveness in reducing waist circumference, blood lipids, blood pressure, blood uric acid, liver enzymes, and liver fat content while improving insulin sensitivity.

The company has two New Drug Applications (NDAs) for mazdutide under review by China's National Medical Products Administration (NMPA). The NDAs pertain to chronic weight management in adults with obesity or overweight and glycemic control in adults with type 2 diabetes. Presently, five Phase 3 studies of mazdutide are underway, targeting various demographics and conditions, including overweight, severe obesity, and type 2 diabetes in newly treated patients. Among these, the GLORY-1, DREAMS-1, and DREAMS-2 studies have successfully achieved their endpoints.

Innovent Biologics, founded in 2011, is committed to making high-quality biologics accessible and affordable. The company is involved in developing treatments for cancer, cardiovascular and metabolic diseases, autoimmune conditions, and eye diseases. Innovent has 11 marketed products, 3 new drug applications under NMPA review, 4 assets in Phase 3 or pivotal clinical trials, and 18 molecules in early clinical stages. The company collaborates with over 30 global healthcare leaders, including Eli Lilly, Roche, and Sanofi. Innovent aims to advance the biopharmaceutical industry by adhering to high industry standards and fostering collaboration to ensure widely accessible, high-quality pharmaceutical drugs.

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