Innovent Announces Mazdutide Demonstrates 80.2% Reduction in Liver Fat Content in Exploratory Analysis of GLORY-1 Phase 3 Weight Management Study at ADA 2024 USA – English APAC – English APAC – Traditional Chinese

SAN FRANCISCO and SUZHOU, China, June 24, 2024 /PRNewswire/ — Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and markets high-quality medicines for the treatment of oncology, autoimmune diseases, cardiovascular and metabolic, ophthalmology and others. major diseases, reports liver fat results from the phase 3 study of mazdutide in overweight or obese Chinese adults (GLORY-1) at the 2024 ADA Scientific Sessions.

Mazdutide (Innovent R&D code: IBI362) is a dual agonist of the glucagon-like peptide-1 receptor (GLP-1R) and the glucagon receptor (GCGR). By activating GLP-1R, it reduces appetite and delays gastric emptying, thereby enabling weight loss. At the same time, through the activation of GCGR, it increases energy expenditure, improves fatty acid oxidation and lipolysis, and reduces liver fat.

Teacher Linong Jithe study’s lead researcher, Peking University People’s Hospital, said: “Metabolic dysfunction-associated fatty liver disease (MAFLD) is one of the most common chronic liver diseases worldwide and the most common comorbidity in overweight and obese individuals in China. Fatty liver disease associated with metabolic dysfunction (MASH) and MAFLD constitute significant unmet clinical needs, making them hot spots for innovative drug development in the metabolism field. In recent years, the potential of GLP-1 drugs to improve MAFLD and MASH has begun to be realized. Yet, due to the central role of glucagon in hepatic fat metabolism, multi-target agonists that simultaneously activate GCGR appear even more promising in the treatment of MAFLD and MASH. In the phase 3 weight loss trial of mazdutide, we observed a significant decrease in liver fat content; the number was higher than that of GLP-1 receptor mono-agonists and other dual-targeted agonists, as reported in other studies. This result confirms that simultaneous activation of GCGR based on GLP-1R agonists can provide greater benefits to the liver. I look forward to further exploring mazdutide in the treatment of MAFLD and MASH. »

In the GLORY-1 trial (ClinicalTrial.gov：NCT05607680), 610 Chinese adults with BMI ≥28 kg/m²or ≥24 kg/m² and at least one weight-related comorbidity were randomized in a 1:1:1 ratio to receive mazdutide 4 mg, 6 mg subcutaneous once weekly, or placebo for 48 weeks.

A total of 92 participants underwent MRI and liver fat content (LFC) measurement by MRI-PDFF at baseline, of which 69 participants (25 with mazdutide 4 mg, 22 with mazdutide 6 mg, and 22 with placebo) had an LFC ≥5. % at baseline and at LFC assessment at week 48, and were included in this exploratory analysis.

Treatment with mazdutide resulted in a significant reduction in LFC and improvement in liver function

• In 69 participants with baseline LFC ≥5% and LFC assessment at week 48, treatment with mazdutide for 48 weeks reduced LFC in a dose-dependent manner, significantly more than placebo (mean relative change from inclusion: −63.3% for mazdutide 4 mg; −73.2% for mazdutide 6 mg;
• In participants with baseline LFC ≥10%, treatment with mazdutide 6 mg resulted in a mean relative reduction of 80.2% in LFC at week 48.

• Compared to placebo, significantly more participants receiving mazdutide achieved ≥30% relative reduction in LFC, ≥50% relative reduction in LFC, and normalization in LFC (<5%) at week 48. Of note, 95.5% of participants on mazdutide 6 mg achieved a ≥30% relative reduction in LFC at week 48, and 77.3% of participants on mazdutide 6 mg achieved an LFC <5% at week 48. week 48.

• Marked reductions in body weight, waist circumference, blood pressure, transaminases and lipids were observed in participants treated with mazdutide.

Dr. Lei Qian, Vice President of Clinical Development of Innoventsaid: “Improved hepatic fat metabolism is one of the important advantages of mazdutide over GLP-1R/GCGR. Consistent with the positive signs of hepatic fat reduction observed in the phase 2 study of mazdutide, results from the GLORY-1 study further confirm that mazdutide can promote hepatic fat metabolism through stimulation of the GCGR and significantly reduce liver fat content. We believe that mazdutide’s outstanding performance in reducing intrahepatic fat shows its promising potential, warranting further exploration of the drug’s clinical value in MAFLD and MASH diseases. We hope to provide improved treatment options to the large population affected by metabolic fatty liver disease.

About obesity
As a chronic disease with complex etiology, obesity is one of the main risk factors for type 2 diabetes, fatty liver, cardiovascular and cerebrovascular diseases, kidney diseases, joint diseases, sleep apnea and various cancers. With economic development and lifestyle changes, the number of obese populations in China jumped to the highest point in the world^(I). The incidence and mortality of cardiovascular disease, type 2 diabetes and certain tumors are also higher in populations with severe obesity. Deaths caused by overweight and obesity accounted for 11.1% of deaths from chronic noncommunicable diseases in 2019, a significant increase from 5.7% in 1990.⁽ⁱⁱ⁾. Overweight and obesity have become serious health problems. Lifestyle intervention is a mainstay treatment option for overweight or obese patients. However, a considerable percentage of patients fail to achieve their desired weight loss goal through simple lifestyle intervention and may require pharmacological intervention. Traditional pharmacological therapies in China have limited efficacy and pose multiple safety concerns, highlighting the unmet clinical need for more effective and safer treatments for the Chinese obese population.

About Mazdutide (IBI362)
Innovent has entered into an exclusive licensing agreement with Eli Lilly and Company (Lilly) for the development and potential commercialization of OXM3 (also known as mazdutide), a dual agonist of GLP-1R and GCGR, in China. As a mammalian oxyntomodulin (OXM) analog, with the effects of GLP-1 receptor agonists to promote insulin secretion, lower blood glucose, and reduce body weight, mazdutide may also increase energy expenditure and improve hepatic fat metabolism through activation of the glucagon receptor. Mazdutide demonstrated robust weight loss and hypoglycemia effects in clinical studies as well as improvements in several cardio-metabolic indicators, including reduction in waist circumference, blood lipids, blood pressure, acid blood urate, liver enzymes, liver fat content and improved insulin sensitivity. Currently, five phase 3 studies of mazdutide in overweight or obese Chinese adults (GLORY-1 and GLORY-2) and type 2 diabetic subjects (DREAMS-1, DREAMS-2 and DREAMS-3) are ongoing. , where GLORY-1 and DREAMS-2 studies met the primary and secondary endpoints.

In February 2024mazdutide’s first NDA was accepted by the CDE of China NMPA for chronic weight management in obese or overweight adults.

About Innovent
Innovent is a leading biopharmaceutical company founded in 2011 with a mission to provide patients around the world with affordable, high-quality biopharmaceutical products. The company discovers, develops, manufactures and markets innovative medicines targeting some of the most incurable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and ocular diseases. Innovent has launched 10 products on the market. It has 4 new drug applications currently under regulatory review, 4 assets in phase III or pivotal clinical trials and 18 additional molecules in early clinical phase. Innovent partners with more than 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center.

Guided by the motto “Start with Integrity, Succeed with Action”, Innovent maintains the highest standards of industry practices and works collaboratively to advance the biopharmaceutical industry so that best-in-class pharmaceutical drugs can become widely available. accessible. For more information, visit www.innoventbio.com or follow Innovent on Facebook and LinkedIn.

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The references

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