Innovent Announces Phase 2 Clinical Study of Higher dose 9 mg Mazdutide (IBI362) in Chinese Adults with Obesity Achieved the 24-Week Primary Endpoint

ROCKVILLIE, Md. and SUZHOU, China, May 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 phase 2 clinical study of higher dose (9 mg) mazdutide (Innovent R&D Code: IBI362) in Chinese adults with obesity achieved the 24-week primary endpoint.

This is a randomized, double-blind, placebo-controlled phase 2 clinical study to evaluate the efficacy and safety of mazdutide 9 mg in Chinese subjects with obesity [body mass index (BMI) ≥30.0 kg/m²]. A total of 80 subjects were enrolled (mean baseline weight 96.9 kg, mean height 168.0 cm, mean BMI 34.3 kg/m²) and randomized in a 3:1 ratio to mazdutide 9 mg group or placebo group to receive treatment once a week for 24 weeks. The primary endpoint is the percent change in body weight from baseline versus placebo after 24 weeks of treatment. The study will also extend treatment to 48 weeks.

The results showed that mazdutide 9 mg demonstrated superior body weight loss versus placebo in Chinese subjects with obesity. After 24 weeks of treatment, the treatment difference of the mean percent change in body weight from baseline versus placebo was -15.4%（95%CI: -18.8%, -11.9%）, P<0.0001; The treatment difference of the mean change in body weight from baseline versus placebo was -14.7 kg（95%CI：-17.9 kg, -11.5 kg），P<0.0001. Meanwhile, 81.7%、65.0%、31.7% and 21.7% of the subjects in the mazdutide 9 mg group achieved 5% or more,10% or more, 15% or more and 20% or more weight loss from baseline, respectively, while no subject in the placebo group lost 5% or more of body weight from baseline.

In terms of safety, the overall tolerability and safety of the mazdutide 9 mg was favorable. The drop-out rate of the mazdutide group was lower than that of the placebo group. No subject in the mazdutide group discontinued treatment due to adverse events. No serious adverse events occurred. Except for COVID-19 infection, the most commonly-reported adverse events were gastrointestinal-related adverse events, most of which were mild or moderate and transient.

The study is still in progress, and the data of other secondary and exploratory endpoints of the study will be analyzed and disclosed after the end of the study.

Professor Linong Ji, the leading principal investigator of the study, Peking University People's Hospital, stated, "The overweight and obese population in China has continued to increase in recent years. There are about 160 million obese people across China (BMI ≥ 28.0 kg/m²), of which approximately 10 million are with moderate and severe obesity (BMI ≥ 32.5 kg/m²). The risk of cardiovascular and cerebrovascular diseases for these patients is extremely high, and the quality of daily life and mental health of these patients are significantly affected. Compared with the general obese population, moderately- to severely- obese patients urgently need effective and safe weight loss options. At present, metabolic surgery is the main treatment for people with a BMI ≥ 32.5 kg/m², other treatment options are limited. Despite the obvious efficacy of surgical weight loss, it is only used in a small number of patients for many reasons. In recent years, the development of GLP-1 receptor agonists, especially a new generation of dual-target agonists, has brought prospects for weight loss drugs. However, there are few clinical studies on GLP-1 receptor agonists in patients with moderate to severe obesity in the world, especially in the Chinese population.

I am pleased to see the weight loss efficacy of mazdutide 9 mg has been further improved versus mazdutide 6 mg while showing good tolerability and safety. The observed efficacy of mazdutide 9 mg after 24 weeks of treatment is approaching that of metabolic surgery, which suggests the potential of mazdutide to become a more ideal therapeutic drug for patients with moderate to severe obesity. This study also fills the gap in the clinical research of drug treatment of patients with severe obesity in Chinese and even East Asian populations. I am hopeful that mazdutide 9 mg will also show satisfactory results in future phase 3 studies."

Dr. Lei Qian, Vice President of Clinical Development at Innovent, stated, " Mazdutide 9 mg achieved the primary endpoint in the phase 2 study of subjects with moderate to severe obesity in China, demonstrated a superior weight loss efficacy to placebo after 24 weeks of treatment while showing good tolerability and safety, which is an important step in the overall indication development strategy and lifecycle management of mazdutide. From a global perspective, weight loss treatments for patients with moderate to severe obesity are extremely limited. Single-target GLP-1 drugs have limited efficacy in this population and can hardly achieve 15% placebo-adjusted weight loss even with one year's treatment. However, the mazdutide 9mg regimen gave encouraging efficacy of 15.4% (14.7kg) placebo-adjusted weigh loss only after 24 weeks, in a population with baseline average BMI of 34.3 kg/m², suggesting it will be effective in the population with greater unmet need for effective therapy. These results are comparable to the most effective multi-target GLP-1 receptor agonist drugs and even bariatric surgery, and a trend of continuous decline of body weight was observed at Week 24 in the study. The study is still in progress and will continue to evaluate the efficacy and safety after 48 weeks of treatment. I am confident that that longer treatment will bring more weight loss efficacy. In addition, we will advance the phase 3 clinical study of mazdutide 9 mg in due course, and strive to provide a drug treatment option that can potentially offer a treatment option where today the only highly effective option is bariatric surgery."

About Obesity

China has the largest overweight and 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 pharmacological therapies have been of limited efficacy and safety issues, highlighting the unmet need for more effective and safe therapies.

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. 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 excellent weight loss and glucose-lowering effects in clinical studies, as well as reducing waist circumference, blood lipids, blood pressure, blood uric acid, liver enzymes and liver fat content, as well as improving insulin sensitivity, bringing multiple metabolic benefits. Currently, three key phase 3 studies of mazdutide 4 mg and 6 mg in Chinese patients with overweight or obesity (GLORY-1) and type 2 diabetic (DREAM-1 and DREAM-2) subjects are underway. The Phase 2 clinical study of mazdutide 9 mg in Chinese patients with obesity is in progress.

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 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 injection), SULINNO® (adalimumab injection), HALPRYZA® (rituximab injection), Pemazyre® (pemigatinib oral inhibitor), olverembatinib（BCR ABL TKI）,Cyramza® (ramucirumab) and Retsevmo® (selpercatinib). An additional 3 assets are under NMPA NDA review, 6 assets are in Phase III or pivotal clinical trials, and 18 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 28 strategic collaborations with Eli Lilly, Roche, 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.

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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