Innovent Announces Phase 2 study of Mazdutide（IBI362） in Chinese Participants with Overweight or Obesity Met Primary and All Key Secondary Endpoints

Rhea-AI Summary

Innovent Biologics announced positive results from a Phase 2 study of mazdutide (IBI362), a dual agonist for treating overweight and obesity in Chinese participants. The study met all primary and key secondary endpoints, with participants achieving a mean weight loss of up to 12.6% compared to placebo. Efficacy was dose-dependent, demonstrating significant reductions in body mass index and other metabolic parameters. The treatment was well tolerated, with only mild and transient side effects. The company is preparing to advance to Phase 3 trials following these encouraging results.

Positive

• Phase 2 study of mazdutide met all primary and key secondary endpoints.
• Participants experienced up to 12.6% mean weight loss compared to placebo.
• Mazdutide demonstrated significant improvements in metabolic parameters.
• Well-tolerated treatment with mild side effects and high completion rate (92.7%).

Negative

• None.

SAN FRANCISCO and SUZHOU, China, June 7, 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, autoimmune, metabolic, ophthalmology and other major diseases, announces that the primary and all key secondary endpoints were met in a randomized, double-blind, placebo-controlled phase 2 study of mazdutide (R&D code: IBI362), a glucagon-like peptide-1 receptor (GLP-1R)/glucagon receptor (GCGR) dual agonist, in Chinese participants with overweight or obesity.

This study (ClinicalTrials.gov, NCT04904913) was designed to evaluate the efficacy and safety of mazdutide in Chinese participants with overweight or obesity. A total of 248 subjects were randomized to receive 1.5-3.0 mg, 1.5-3.0-4.5 mg, or 2.0-4.0-6.0 mg of mazdutide or placebo subcutaneously and once-weekly for 24 weeks. The primary endpoint was the percentage change from baseline in body weight at week 24. A total of 230 participants (92.7%) completed week 24.

Mazdutide demonstrated superior weight loss efficacy in Chinese participants with overweight or obesity compared with placebo in a dose-dependent manner. After 24 weeks of treatment:

• The least squares (LS) mean percent change (absolute change) from baseline in body weight were − 7.21% (−6.35 kg on 3.0 mg), − 10.56% (−9.07 kg on 4.5 mg) and −11.57% (−9.85 kg on 6.0 mg) with mazdutide, compared with 1.05% (1.08 kg) with placebo. The treatment difference versus placebo in LS mean percent change from baseline were −8.26% ([95%CI：−10.12, −6.40] on 3.0 mg), −11.60% ( [−13.43, −9.77] on 4.5 mg) and −12.62% ( [−14.47, −10.76] on 6.0 mg) (p < 0.0001 for all comparisons).
• The proportion of participants with ≥ 5% body weight loss from baseline was 58.1% (3.0 mg), 82.5% (4.5 mg), and 80.3% (6.0 mg) with mazdutide, compared with 4.8% with placebo.
• The proportion of participants with ≥ 10% body weight loss from baseline was 19.4% (3.0 mg), 49.2% (4.5 mg), and 50.8% (6.0 mg) with mazdutide, compared with 0% with placebo.

Meanwhile, mazdutide markedly reduced body-mass index, waist circumference, liver fat content and blood pressure; lowered lipid, transaminase and serum uric acid levels, and improved insulin sensitivity, delivering comprehensive metabolic benefits for participants with overweight or obesity.

In terms of safety, mazdutide was well tolerated. Only one participant discontinued the treatment due to an adverse event, which was not related to mazdutide as judged by the investigator. The overall safety profile was similar to those observed in early phase development and with other GLP-1-based agonists and co-agonists. The most frequently-reported treatment-emergent adverse events were diarrhea, nausea and upper respiratory tract infection, mostly mild or moderate in severity and transient.

Professor Linong Ji, the principal investigator of the study, Peking University People's Hospital, stated, " In recent years, the prevalence of obesity in China has increased rapidly and resulted in the increase of the prevalence of diabetes, fatty liver, sleep disorders and cardiovascular diseases. Therefore, effective and safe weight-loss drugs are urgently needed. We are pleased to see the exciting results of the phase 2 study of mazdutide in Chinese participants with overweight or obesity, suggesting that mazdutide could potentially be the best-in-class agent. The half-year treatment of mazdutide achieved on average −12.6% weight reduction from baseline compared with placebo, which was comparable to the most cutting-edge weight-loss drugs under development in the world. The excellent efficacy of mazdutide in weight loss and multiple metabolic parameters truly reflects the advantages of weekly formulation based on dual incretin receptor agonists. I am confident and looking forward to the success of mazdutide in the upcoming phase 3 study."

Dr. Lei Qian, Vice President of Clinical Development of Innovent, stated, "The Phase 2 study of mazdutide in Chinese participants with overweight or obesity achieved the primary and all key secondary endpoints, while showing improvement on multiple metabolic parameters including blood pressure, lipids, transaminase and serum uric acid. These results demonstrate the great utility value of GLP-1R/GCGR dual agonist, further demonstrating the potential to be the best-in-class agent and paving solid foundation for further clinical development. Of note, the auto-injector has been used in the phase 2 studies, greatly improving the quality of life and compliance of participants, while demonstrating the quality and capability of domestic enterprises in device development and manufacturing; we will actively promote the development of phase 3 clinical study of mazdutide and anticipate more clinical data later this year, striving to provide more convenient, user-friendly, effective and safe drug for overweight and obese population as soon as possible."

* Due to the outbreak of Covid-19, the data are being collected and under further analysis. The data disclosed in this press release may have some deviation from the final results.

About Obesity

China has the largest obese population in the world, with obesity rate likely to increase. Obesity can lead to a range of complications or related diseases that impact life expectancy and lead to a decrease in 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 due to various reasons and may require pharmacological intervention. Traditional anti-obesity drugs have limited weight-loss effects and are associated with safety issues.

About Mazdutide (IBI362)

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), which uses a fatty acid side chain to prolong the duration of action and allow once-weekly administration. Mazdutide is thought to exert its biological effects by activating 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. The treatment of metabolic diseases by activating multiple metabolism-related targets simultaneously is currently the worldwide trend in drug development.

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, metabolic, ophthalmology 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 32 valuable assets in the fields of cancer, autoimmune, metabolic, ophthalmology and other major therapeutic areas, with 7 products approved for marketing in China – TYVYT® (sintilimab injection), BYVASDA® (bevacizumab biosimilar injection), SULINNO® (adalimumab biosimilar injection), HALPRYZA® (rituximab biosimilar injection) , Pemazyre® (pemigatinib oral inhibitor) and olverembatinib (BCR-ABL TKI) and Cyramza® (ramucirumab), 2 asset under NMPA NDA review, 4 assets in Phase 3 or pivotal clinical trials, and an additional 19 molecules 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, Adimab, Incyte, MD Anderson Cancer Center, Hanmi 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.

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 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.

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SOURCE Innovent Biologics

FAQ

What were the results of the phase 2 study of mazdutide (IVBIY)?

The phase 2 study met all primary and key secondary endpoints, showing up to 12.6% weight loss compared to placebo in Chinese participants.

What are the next steps for mazdutide after the phase 2 study?

Innovent plans to advance to Phase 3 clinical trials following the successful Phase 2 results.

How well was mazdutide tolerated in the trial?

Mazdutide was well tolerated, with only one participant discontinuing due to an unrelated adverse event.

What implications does the phase 2 study have for the obesity market in China?

The positive results positioning mazdutide as a potential best-in-class agent could address the urgent need for effective weight-loss drugs in China.