Innovent Announces the First Phase 3 Clinical Trial of Mazdutide in Chinese Adults with Overweight or Obesity Met the Primary and All Key Secondary Endpoints, and Plans to Submit NDA of Mazdutide to the NMPA

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Innovent Biologics, Inc. (Innovent) (HKEX: 01801) announces successful Phase 3 trial of mazdutide for weight management in Chinese adults with overweight or obesity, meeting primary and key secondary endpoints with positive safety profile.

ROCKVILLE, Md. and SUZHOU, China, Jan. 8, 2024 /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, autoimmune, cardiovascular and metabolic, ophthalmology and other major diseases, announces that the first Phase 3 clinical trial 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 (GLORY-1) met the primary endpoints and all key secondary endpoints. Innovent plans to submit the first new drug application (NDA) of mazdutide for weight management to the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) in the near term.

GLORY-1 (NCT05607680) is a multi-center, randomized, double-blind, placebo-controlled Phase 3 clinical trial to evaluate the efficacy and safety of mazdutide in Chinese adults with overweight or obesity[i]. A total of 610 participants were randomized to receive mazdutide 4 mg, 6 mg or placebo in the 48-week double-blind treatment period.

The GLORY-1 study met both primary endpoints– mazdutide 4 mg and 6 mg showed superiority to placebo in terms of the percentage change in body weight from baseline to week 32 and the proportion of participants with a weight loss of ≥5% at week 32. The weight-loss efficacy was further improved from week 32 to week 48.

Furthermore, all key secondary endpoints of the study were met, including the proportion of participants with a weight loss of ≥10% or ≥ 15%, as well as the changes in waist circumference, systolic blood pressure, triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), total cholesterol, serum uric acid, and alanine aminotransferase (ALT). Mazdutide demonstrated superiority to placebo in all the above weight-loss and cardiometabolic endpoints.

During the double-blind treatment period, the safety profile of mazdutide was similar to those observed in previous clinical studies, and no new safety signals were observed.

Mazdutide is the first GLP-1R/GCGR dual agonist succeeding in Phase 3 trials. As mazdutide's first registrational trial for weight management, the results of GLORY-1 not only further confirm the efficacy and safety of the mazdutide in a large population, but also provide high-quality clinical evidence of long-term pharmacotherapy weight management specifically for the Chinese population with overweight or obesity.

Professor Linong Ji, the leading principal investigator of the study, Peking University People's Hospital, stated, " As a chronic disease with a complex etiology, obesity requires public awareness of long-term treatment and management with effective and science-backed approaches. Clinical evidence shows that for individuals with overweight or obesity, reducing weight through lifestyle management or medications could reduce metabolic and cardiovascular risks and eventually improve health outcomes. Together with other investigators in the study, I'm pleased to see the GLORY-1 study met the primary endpoints and all key secondary endpoints, with results consistent with those of phase 2 clinical trials of mazdutide. The results of GLROY-1 once again demonstrated the robust weight-loss efficacy, multiple cardiometabolic benefits and good safety of mazdutide as a new-generation GLP-1R/GCGR dual agonist. I look forward to the publication of the full results and the NDA and launch of mazdutide to fulfill the need of hundreds of millions overweight or obese people in China."

Dr. Lei Qian, Vice President of Clinical Development of Innovent, stated, " Mazdutide pioneers a new generation of weight-loss drugs as a novel GLP-1R/GCGR dual agonist, with accumulated clinical data on more than a thousand Chinese participants. The results of the GLORY-1 study show that mazdutide has strong weight-loss efficacy with favorable safety and tolerability. We are further preparing the results and plan to submit the first NDA of mazdutide for weight management in the near term. We endeavor to provide a safe and effective weight management medication for Chinese people with overweight or obesity. We are also developing mazdutide for other indications on the basis of scientific evidence and unmet medical needs. Innovent will continue to strategically build our next-generation product pipeline in the cardiovascular and metabolic (CVM) field, and help people's pursuit of a healthy life."

About Obesity

As a chronic disease with a complex etiology, obesity is one of the leading risk factors of type 2 diabetes, fatty liver, cardiovascular and cerebrovascular diseases, kidney diseases, joint diseases, sleep apnea in addition to cancers. With economic development and lifestyle changes, the number of obese population in China has jumped to the highest in the world[ii]. The incidence and mortality of cardiovascular disease, type 2 diabetes and certain tumors are also higher in population with severe obesity. Deaths caused by overweight and obesity accounted for 11.1% of deaths related to chronic non-communicable diseases in 2019, a significant increase from 5.7% in 1990[iii]. Overweight and obesity have become a serious health problem. Lifestyle intervention is a basic treatment option for patients with overweight or obesity. However, a considerable percentage of patients fail to achieve the desired weight loss goal through merely  lifestyle intervention and may require pharmacological intervention. Traditional pharmacological therapies in China have limited efficacy and multiple safety issues, highlighting the unmet clinical need of more effective and safe therapies for the Chinese obese population.

About Mazdutide (IBI362)

Innovent entered into an exclusive license 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. As a mammalian oxyntomodulin (OXM) analogue, 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. Mazdutide has demonstrated robust weight loss and glucose-lowering effects in clinical studies, as well as multiple cardio-metabolic benefits including reducing waist circumference, blood lipids, blood pressure, blood uric acid, liver enzymes, liver fat content and improving insulin sensitivity. Currently, four Phase 3 studies of mazdutide in Chinese patients with overweight or obesity (GLORY-1 and GLORY-2) and type 2 diabetic (DREAMS-1 and DREAMS-2) subjects are underway, where GLORY-1 study has met the primary and all key secondary endpoints.

About Innovent

Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to discover and develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to discovering and developing, manufacturing and commercializing high-quality innovative medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, and ophthalmology diseases to enhance the quality of the patients' lives. Innovent has 10 products in the market, 2 NDA under NMPA review, 5 assets in Phase III or pivotal clinical trials, and 19 more molecules in early clinical stage. Innovent has also entered into 30 strategic collaborations with Eli Lilly, Roche, Sanofi, Adimab, Incyte, MD Anderson Cancer Center and other international partners. We strive to work with many collaborators to help advance the biopharmaceutical industry, improve drug availability and enhance the quality of the patients' lives.

Note:

TYVYT^® (sintilimab injection), 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: 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 Biologics ("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.

[i] Study inclusion criteria: body mass index (BMI) ≥28 kg/m², or ≥24 kg/m² with at least one of the following comorbidities: prediabetes, hypertension, dyslipidemia, fatty liver, weight bearing joint pain, obesity-related dyspnea or obstructive sleep apnea.

[ii] Pan XF, Wang L, Pan A. Epidemiology and determinants of obesity in China. Lancet Diabetes Endocrinol 2021; 9: 373–92.

[iii] Institute for Health Metrics and Evaluation. Global Health Data Exchange. GBD results tool. http://ghdx.healthdata.org/gbd-resultstool (accessed Jan 10, 2021).

 

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SOURCE Innovent Biologics

FAQ

What is the latest development from Innovent Biologics, Inc. (Innovent) (HKEX: 01801)?

Innovent Biologics, Inc. (Innovent) (HKEX: 01801) has announced the successful Phase 3 clinical trial of mazdutide for weight management in Chinese adults with overweight or obesity, meeting primary and key secondary endpoints.

What are the primary endpoints that mazdutide has met in the Phase 3 trial?

Mazdutide has shown superiority to placebo in terms of the percentage change in body weight from baseline to week 32 and the proportion of participants with a weight loss of ≥5% at week 32.

What are the key secondary endpoints that mazdutide has met in the Phase 3 trial?

The key secondary endpoints of the study were met, including the proportion of participants with a weight loss of ≥10% or ≥ 15%, as well as the changes in waist circumference, systolic blood pressure, triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), total cholesterol, serum uric acid, and alanine aminotransferase (ALT).

What is the safety profile of mazdutide in the Phase 3 trial?

During the double-blind treatment period, the safety profile of mazdutide was similar to those observed in previous clinical studies, and no new safety signals were observed.

Who is the leading principal investigator of the study for mazdutide?

Professor Linong Ji, the leading principal investigator of the study, is from Peking University People's Hospital.

What is the plan for mazdutide after the successful Phase 3 trial?

Innovent plans to submit the first new drug application (NDA) of mazdutide for weight management to the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) in the near term.