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

ROCKVILLE, Md. and SUZHOU, China, Jan. 10, 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, dulaglutide-controlled phase 3 clinical trial (DREAMS-2) 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 study (ClinicalTrials.gov, NCT05606913) will compare the efficacy and safety of mazdutide and dulaglutide in Chinese subjects with type 2 diabetes who have inadequate glycemic control with metformin monotherapy or combination therapy of metformin with sodium-glucose cotransporter 2 (SGLT2) inhibitors or sulfonylureas. The study plans to enroll approximately 720 subjects in a 1:1:1 ratio to receive either mazdutide 4.0 mg, mazdutide 6.0 mg or dulaglutide 1.5 mg for 28 weeks. The primary endpoint will be the change from baseline to week 28 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 reduced blood pressure, blood lipids and liver enzyme levels, offering metabolic benefits to subjects.

The DREAMS-2 study will further evaluate the efficacy and safety of mazdutide and compare the efficacy and safety of mazdutide and dulaglutide.

Professor Wenying Yang, the principal investigator of the study, China Japan Friendship Hospital, stated, "There is still a low overall rate of achieving glycemic control in patients with type 2 diabetes in China. Patients with type 2 diabetes tend to have co-morbidities that increase cardiovascular risk, such as obesity, hyperlipidemia, coronary heart disease, fatty liver, and gout, which not only increases the disease burden but also raises the difficulty of treatment. Innovative drugs with strong efficacy, good safety, convenient administration, low risk of hypoglycemia, and multiple cardiovascular benefits are urgently needed in clinical practice. The phase 2 clinical study in Chinese patients with type 2 diabetes showed significant glucose-lowering efficacy of mazdutide, and it also showed the potential superiority of mazdutide to dulaglutide in weight-loss efficacy. I hope that mazdutide will achieve strong phase 3 study results, and look forward to its potential application for marketing to benefit patients."

Professor Lixin Guo, the principal investigator of the study, Beijing Hospital, stated, "GLP-1 drugs have gained increasing attention and been increasingly used by first-line clinicians because of their glucose lowering efficacy, low risk of hypoglycemia, significant weight benefit and protection of target organs. At present, GLP-1 dual-target drugs are becoming a hot spot in the development of the next generation of GLP-1 products, as multi-target mechanism will potentially bring superior glucose lowering and weight-loss benefits. As a promising example of GLP-1 dual-target drugs, mazdutide has been extensively researched and developed in Chinese patients with type 2 diabetes. The results of its phase 2 study have shown good glucose lowering and weight-loss efficacy, blood lipids, blood pressure and blood uric acid improvement, liver protection as well as other multiple benefits. As an innovative molecule in the dual-target field of GLP-1 whose clinical evidence are mostly in China, mazdutide may offer a superior, innovative choice for Chinese doctors and patients."

Dr. Lei Qian, Vice President of Clinical Development at Innovent, stated, "The results of the phase 2 study of mazdutide in Chinese patients with type 2 diabetes fully demonstrate the efficacy and good safety of GLP-1R/GCGR dual agonists, showing potential clinical value. These results lay a solid foundation for the phase 3 study. We look forward to expanded evidence of mazdutide's efficacy and safety in the Chinese population. The overall development plan and pivotal study designs of mazdutide in China have been communicated with and received positive feedback from regulatory authorities, based on which we will continue to conduct efficient and solid clinical research and development."

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.

Forward-looking statement

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