Innovent Announces First Participant Dosed in a Phase 3 Clinical Study (GLORY-1) of Mazdutide (IBI362) in Chinese Adults with Overweight or Obesity

ROCKVILLE, Md. and SUZHOU, China, Nov. 14, 2022 /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 phase 3 clinical trial (GLORY-1) of mazdutide (Innovent R&D Code: IBI362), a glucagon-like peptide 1 receptor (GLP-1R) and glucagon receptor (GCGR) dual agonist, in Chinese adults with overweight or obesity.

This randomized, double-blinded, placebo-controlled phase 3 clinical study was designed to evaluate the efficacy and safety of mazdutide in Chinese adults with overweight or obesity (GLORY-1) (NCT05607680). Mazdutide is the first GLP-R/GCGR dual agonist to enter a phase 3 pivotal study for the treatment of obesity. The study plans to enroll 600 subjects in a 1:1:1 ratio to receive either mazdutide 4mg, mazdutide 6mg or placebo for 48 weeks. The primary endpoints include the percentage change in body weight from baseline to week 32 and the proportion of subjects with 5% or more body weight loss from baseline at week 32. In a randomized, double-blind, placebo-controlled phase 2 clinical study of mazdutide in Chinese adults with overweight or obesity (ClinicalTrials.gov, NCT04904913), mazdutide titrated to 6mg achieved mean body weight loss of 11.57% at week 24. Meanwhile, mazdutide markedly reduced waist circumference, blood pressure, lipids, blood uric acid, transaminase and liver fat, bringing multiple metabolic benefits to the subjects. In the phase 2 study, mazdutide was well tolerated and the overall safety profile was similar to other GLP-1 class drugs. The GLORY-1 study will further evaluate the long-term efficacy and safety of mazdutide in Chinese adults with overweight or obesity.

Professor Linong Ji, the principal investigator of the study, Peking University People's Hospital, stated, "Obesity is associated with a variety of chronic non-communicable diseases and is listed as one of the important risk factors that impose health burden to the human society[1]. The number and growth rate of obesity in China rank first place in the world. Thus, effective and safe body weight loss drugs are urgently needed. The results of the phase 2 study showed that mazdutide, a GLP-1R/GCGR dual agonist, demonstrated robust body weight loss efficacy and comprehensive metabolic improvement in Chinese adults with overweight or obesity, underlying its best-in-class potential. Of note, the target population in this phase 3 study of mazdutide is different from those in pivotal studies of approved drugs of the same class, the latter were mainly western Caucasian populations with higher BMI. Our planned Phase 3 clinical studies of mazdutide will provide large-scale clinical evidence which will be more representative of the Chinese population to shed light on clinical practice. I am looking forward to more exciting results of mazdutide in the phase 3 clinical study and hope mazdutide will become an innovative and potentially best-in-class anti-obesity drug."

Dr. Lei Qian, Vice President of Clinical Development at Innovent, stated, "The results of the phase 2 study of mazdutide in Chinese adults with overweight or obesity fully demonstrate the clinical value of GLP-1R/GCGR dual agonists and further reflect the best-in-class potential of mazdutide among GLP-1 receptor agonists and co-agonists. These results lay a solid foundation for the phase 3 program. We are confident that we will see continued evidence of mazdutide's efficacy and safety over a longer period of time in a Chinese population. Mazdutide is the first GLP-1R/GCGR dual agonist to enter a pivotal study for the treatment of obesity, representing a milestone in clinical development. With efficient and scientifically driven clinical development, we hope to bring mazdutide to patients as soon as possible, providing a new, efficacious, safe and patient-friendly treatment option for adults with overweight and obesity."

About Overweight and Obesity

China has the largest obese population in the world, with the obesity rate likely to increase. Obesity can lead to a range of complications or related diseases that impact life expectancy and deteriorate the quality of life. In more severely obese patients, the incidence and mortality of cardiovascular disease, diabetes, and certain tumors increase significantly. Obesity is a chronic disease that requires long-term management, and there is a lack of long-term effective and safe treatments. Lifestyle intervention is the first choice and basic treatment for patients with overweight or obesity. However, a considerable percentage of patients fail to achieve the desired weight loss goal upon lifestyle intervention and may require pharmacological intervention. Traditional anti-obesity drugs have limited weight-loss effects and are associated with safety issues.

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.

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 35 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 (BCRABLTKI), Cyramza (ramucirumab) and selpercatinib. An additional 2 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.

Selpercatinib (Eli Lilly). Selpercatinib 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

This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. The Company does not intend to update these forward-looking statements regularly.

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of the Company with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond the Company's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, the Company's competitive environment and political, economic, legal and social conditions.

The Company, the Directors and the employees of the Company assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialise or turn out to be incorrect.

View original content: https://www.prnewswire.com/news-releases/innovent-announces-first-participant-dosed-in-a-phase-3-clinical-study-glory-1-of-mazdutide-ibi362-in-chinese-adults-with-overweight-or-obesity-301676778.html

SOURCE Innovent Biologics