Innovent Announces Successful Phase 3 Trial Results for Mazdutide in Type 2 Diabetes Patients in China and Plans to Submit NDA to NMPA
Monday, July 22, 2024
Innovent Biologics, Inc. (HKEX: 01801), a leading biopharmaceutical firm focusing on treatments for oncology, autoimmune conditions, cardiovascular diseases, metabolic disorders, and ophthalmology, has announced encouraging outcomes from its Phase 3 clinical trial of mazdutide (Innovent R&D code: IBI362). Mazdutide is a dual agonist targeting both the glucagon-like peptide-1 receptor (GLP-1R) and the glucagon receptor (GCGR).
The DREAMS-1 trial, a randomized, double-blind, placebo-controlled study, evaluated mazdutide’s efficacy and safety in Chinese adults with type 2 diabetes (T2D) who were not adequately managing their condition with diet and exercise alone. The study enrolled 320 participants, who were randomly assigned to receive 4 mg or 6 mg of mazdutide or a placebo for 24 weeks. After the initial 24 weeks, participants who had received the placebo switched to 6 mg mazdutide for an additional 24 weeks. The primary endpoint was the change in glycated hemoglobin (HbA1c) from baseline at week 24.
Mazdutide successfully met the primary endpoint, demonstrating significant reductions in HbA1c levels. By week 24, HbA1c decreased by 1.57% in the 4 mg group and 2.15% in the 6 mg group, compared to a 0.14% reduction in the placebo group (both p-values < 0.0001). This reduction in HbA1c was sustained through week 48.
Beyond glucose control, mazdutide also resulted in substantial weight loss compared to the placebo. By week 48, participants in the 6 mg group experienced an average weight loss of 9.6% from baseline. Additionally, mazdutide improved various cardiovascular metabolic indicators, including postprandial blood glucose, waist circumference, blood pressure, blood lipids, liver enzymes, and urinary albumin-to-creatinine ratio.
Mazdutide’s safety profile was favorable, with no new safety concerns. The most common adverse events were gastrointestinal, mostly mild to moderate. The incidence of hypoglycemia was low, with no severe cases reported.
Innovent plans to submit a new drug application (NDA) for mazdutide to the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA), following the acceptance of its first NDA for chronic weight management in February 2024.
Professor Dalong Zhu from Affiliated Drum Tower Hospital, Nanjing University, noted the comprehensive benefits of mazdutide, including its effectiveness in managing glucose levels, body weight, and other metabolic markers, and expressed hope for its swift market release. Professor Jiajun Zhao from Shandong Provincial Hospital emphasized the critical need for innovative treatments for diabetes in China due to the country’s high prevalence of the disease.
Dr. Lei Qian, Vice President of Clinical Development at Innovent, highlighted the promising results of DREAMS-1 and DREAMS-2, showcasing mazdutide’s broad efficacy in managing T2D and its complications. The company is also anticipating results from the DREAMS-3 study, which will compare mazdutide with semaglutide.
The International Diabetes Federation reports that China has the highest number of diabetes cases globally, with over 140 million patients in 2021, projected to reach 174 million by 2045. Effective diabetes management involves controlling blood glucose as well as addressing associated complications such as weight management, cardiovascular risk, and kidney protection.
Mazdutide is a dual agonist of the GLP-1R and GCGR, developed through a licensing agreement with Eli Lilly and Company. As an analogue of mammalian oxyntomodulin (OXM), mazdutide aids in insulin secretion and blood glucose reduction similar to GLP-1 receptor agonists, while also potentially enhancing energy expenditure and improving liver fat metabolism. Clinical studies have shown its efficacy in weight loss and glucose control, along with multiple cardiovascular and metabolic benefits.
Innovent is advancing mazdutide through several Phase 3 trials, including studies on weight management, obesity, and type 2 diabetes, with GLORY-1, DREAMS-1, and DREAMS-2 already meeting their endpoints.
Source: innoventbio.com
