Innovent Announces First Participant Dosed in a Phase 3 Clinical Study (DREAMS-1) of Mazdutide (IBI362) in Chinese Patients with Type 2 Diabetes

ROCKVILLE, Md. and SUZHOU, China, Jan. 9, 2023 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, metabolic, autoimmune, ophthalmology and other major diseases, today announced that the first participant has been successfully dosed in a multicenter, randomized, double-blind, placebo-controlled phase 3 clinical trial (DREAMS-1) of mazdutide (Innovent R&D Code: IBI362), a glucagon-like peptide 1 receptor (GLP-1R) and glucagon receptor (GCGR) dual agonist, in Chinese patients with type 2 diabetes.

This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical study to evaluate the efficacy and safety of mazdutide in Chinese patients with type 2 diabetes inadequately controlled by diet and exercise alone (ClinicalTrials.gov, NCT05628311). The study plans to enroll approximately 300 subjects, randomized in a 1:1:1 ratio, to receive either mazdutide 4.0 mg, mazdutide 6.0 mg or placebo. The study treatment period will be 48 weeks in total, including a 24-week double-blind treatment period and a 24-week extension treatment period. The primary endpoint will be the change from baseline to week 24 in glycated hemoglobin (HbA1c) levels.

In a phase 2 clinical study of mazdutide in Chinese patients with type 2 diabetes（ClinicalTrials.gov, NCT04965506）, mazdutide was well tolerated and the overall safety profile was similar to other GLP-1 class drugs.

• The mean change in HbA1c from baseline to week 20 was up to -1.67% with mazdutide (0.03% with placebo and -1.35% with dulaglutide).
• The mean change in body weight from baseline to week 20 was up to -7.11% with mazdutide (-1.38% with placebo and -2.69% with dulaglutide).
• In the study, mazdutide also offered multiple metabolic benefits to subjects, including reduced blood pressure, blood lipids and liver enzyme levels.

The DREAMS-1 study will further evaluate the long-term efficacy and safety of mazdutide in Chinese patients with type 2 diabetes inadequately controlled by diet and exercise alone.

Professor Dalong Zhu, the principal investigator of the study, Nanjing Drum Tower Hospital, stated, "Diabetes has become a global health problem. At present, there are many kinds of medicines for the treatment of diabetes, and GLP-1 receptor agonists have been widely used in recent years because of their good efficacy and safety, especially the function of cardiovascular protection. The latest research and development direction of GLP-1 receptor agonists is multi-target. Mazdutide, as a representative of the next generation of GLP-1 multi-target receptor agonists, not only has a significant hypoglycemic and weight-loss effect but also reduces blood pressure, blood lipids and liver enzymes in the phase 2 study, suggesting that mazdutide may be able to effectively control blood glucose while also offering multiple metabolic benefits to patients with type 2 diabetes. In addition, both the once-weekly dosing regimen and innovative autoinjector device can significantly improve the quality of life and compliance of patients. I look forward to mazdutide delivering excellent efficacy in the phase 3 study and will potentially bring a new treatment option to more patients with type 2 diabetes."

Professor Jiajun Zhao, the principal investigator of the study, Shandong Provincial Hospital, stated, "With the economic development of China, the prevalence of diabetes and other metabolic diseases, such as obesity, gout, hyperlipidemia, etc. has gradually increased in China, especially the patients with diabetes and multiple diseases tend to be exposed to significantly increased cardiovascular risk factors, which leads to the increased burden of disease as well as the socio-economic burden for patients. Thus, treatments that can significantly reduce blood glucose, body weight, and multiple cardiovascular risk factors are urgently needed. Mazdutide, as a new GLP-1R/GCGR dual agonist worldwide, has a novel mechanism, in addition to the GLP-1 receptor, its additional agonistic glucagon receptor may bring benefits such as increasing basal metabolic rate, improving blood lipid profile, reducing liver fat, and enhancing appetite suppression. In the phase 2 clinical study, mazdutide have been shown to have significant glucose-lowering and weight-loss efficacy in Chinese patients with type 2 diabetes, and may offer multiple benefits to patients, including a favorable safety profile. I am confident that mazdutide will be successful in phase 3 clinical study and look forward to more clinical value of mazdutide to be unlocked."

Dr. Lei Qian, Vice President of Clinical Development at Innovent, stated, "Mazdutide is a dual GLP-1R/GCGR agonist with both hypoglycemic and weight-loss efficacy, reflecting the best-in-class potential among GLP-1 receptor agonists and co-agonists. The results of the phase 2 study in Chinese subjects with type 2 diabetes demonstrated the efficacy and safety of mazdutide, showing significant clinical value and laying a solid foundation for the phase 3 program. We hope to bring mazdutide to patients as soon as possible, providing a new, efficacious, safe and patient-friendly treatment option for patients with type 2 diabetes."

About Diabetes

The prevalence of diabetes among adults in China is 11.6%, of which type 2 diabetes accounts for about 90% of the total number of diabetic patients, and the number of patients is still increasing. Poor glycemic control will lead to irreversible microvascular and macrovascular complications such as decreased visual acuity, blindness, renal insufficiency, peripheral neuropathy, myocardial infarction, stroke, amputation, etc. As a latent disease with serious complications and high incidence, diabetes mellitus has seriously threatened human health. Currently, there are many treatment options for diabetes, and in addition to effective glycemic control, the development of new hypoglycemic drugs may also provide additional benefits for diabetic patients in terms of weight loss and cardiovascular risk reduction.

About Mazdutide

Innovent entered into a licensing agreement with Eli Lilly and Company (Lilly) for the development and potential commercialization of OXM3 (also known as mazdutide), a GLP-1R and GCGR dual agonist, in China. In parallel, Lilly is developing OXM3 outside China. Mazdutide is a long-acting synthetic peptide related to mammalian oxyntomodulin (OXM) with a fatty acid side chain attached thereto. Mazdutide exhibits a prolonged duration of action allowing for once-weekly administration. Mazdutide is thought to exert its biological effects by activating the GLP-1 receptor and glucagon receptor in human beings, which improves glucose tolerance and induces weight loss, mimicking the effects of endogenous oxyntomodulin. In addition to the effects of GLP-1 receptor agonists on promoting insulin secretion, lowering blood glucose and reducing body weight, mazdutide may also increase energy expenditure and improve hepatic fat metabolism through the activation of glucagon receptor. 

About Innovent

Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high-quality innovative medicines for the treatment of cancer, autoimmune disease, metabolic disorder and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK.

Since its inception, Innovent has developed a fully integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a robust pipeline of 36 valuable assets in the fields of cancer, metabolic disorder, autoimmune disease and other major therapeutic areas, with 8 approved products on the market. These include:  TYVYT^® (sintilimab injection), BYVASDA^® (bevacizumab biosimilar injection), SULINNO^® (adalimumab biosimilar injection), HALPRYZA^® (rituximab biosimilar injection) , Pemazyre^® (pemigatinib oral inhibitor), olverembatinib (BCR-ABL TKI) , Cyramza^® (ramucirumab) and Retsevmo^® (selpercatinib). An additional 3 assets are under NMPA NDA review, 5 assets are in Phase 3 or pivotal clinical trials, and 20 more molecules are in clinical studies.

Innovent has built an international team with advanced talent in high-end biological drug development and commercialization, including many global experts. The company has also entered into strategic collaborations with Eli Lilly and Company, Sanofi, Adimab, Incyte, MD Anderson Cancer Center and other international partners. Innovent strives to work with many collaborators to help advance China's biopharmaceutical industry, improve drug availability and enhance the quality of the patients' lives. For more information, please visit: www.innoventbio.com. and www.linkedin.com/company/innovent-biologics/.

Note:

TYVYT^® (sintilimab injection) is not an approved product in the United States.

BYVASDA^® (bevacizumab biosimilar injection), SULINNO^®, and HALPRYZA^® (rituximab biosimilar injection) are not approved products in the United States.

TYVYT^® (sintilimab injection, Innovent)

BYVASDA^® (bevacizumab biosimilar injection, Innovent)

HALPRYZA^® (rituximab biosimilar injection, Innovent)

SULINNO^® (adalimumab biosimilar injection, Innovent)

Pemazyre^® (pemigatinib oral inhibitor, Incyte Corporation). Pemazyre^® was discovered by Incyte Corporation and licensed to Innovent for development and commercialization in Mainland China, Hong Kong, Macau and Taiwan.

CYRAMZA^® (ramucirumab, Eli Lilly). Cyramza^® was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China.

Retsevmo^® (selpercatinib, Eli Lilly). Retsevmo^® was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China.

Disclaimer:

1. This indication is still under clinical study, which hasn't been approved in China.

2. Innovent does not recommend any off-label usage.

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