Innovent Releases Results of High-dose Cohorts in Phase 1 Clinical Study of Mazdutide (IBI362) in Chinese Adults with Overweight or Obesity at ENDO 2022

SAN FRANCISCO and SUZHOU, China, June 12, 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, announces that the results of high-dose cohorts in a phase 1 clinical trial of mazdutide (IBI362), a glucagon-like petide-1 (GLP-1) and glucagon receptor dual agonist, in Chinese adults with overweight or obesity are presented as an on-demand poster (ODP014) at ENDO 2022.

This randomized, double-blind, placebo-controlled multiple-ascending-dose study (ClinicalTrials.gov, NCT04440345) evaluated the safety, tolerability and PK/PD characteristics of mazdutide in Chinese participants with overweight or obesity. Twelve participants in each of the five cohorts were randomized 2:1 to receive subcutaneous 1.0-2.0-3.0 mg (cohort 1), 1.5-3.0-4.5 mg (cohort 2), 2.0-4.0-6.0 mg (cohort 3), 2.5-5.0-7.5-10.0 mg (cohort 4) or 3.0-6.0-9.0 mg (cohort 5) mazdutide or placebo once weekly, with each dose level administered for 4 weeks. Each cohort of participants received administration for 12 weeks in total except that participants in cohort 4 received administration for 16 weeks.

• In cohort 1-3 (low-dose), mazdutide demonstrated favorable tolerability and a safety profile, with mean percent reduction from baseline in body weight of up to 6.4% for participants receiving mazdutide at week 12. Meanwhile, improvements in BMI, waist circumference, blood pressure, lipid and serum uric acid were observed in participants receiving mazdutide. The results have been published in EclinicalMedicine¹.
• Results of cohort 4 and 5 (high-dose) were firstly presented at ENDO 2022. The mean reduction (percent reduction) from baseline in body weight were 7.62 kg (9.5%) for participants receiving mazdutide at week 16 in cohort 4, and 9.23 kg (11.7%) for participants receiving mazdutide at week 12 in cohort 5. Four participants (50%) receiving mazdutide in each cohort achieved ≥10% weight loss and two (25%) receiving mazdutide in each cohort achieved ≥15% weight loss during the study. Improvements in BMI, waist circumference, blood pressure, lipid and serum uric acid were similar with those observed in the low-dose cohorts.
• Mazdutide up-titrated to 10 mg and 9 mg showed a similar safety profile with that of low-dose cohorts. No participant discontinued the study due to adverse events. No dose adjustment of mazdutide was made. No serious adverse event was reported.

Professor Linong Ji, the Principal Investigator of the Study, Peking University People's Hospital, stated: "The obese population in China exceeded 100 million. Most patients failed to achieve weight loss goals by lifestyle intervention, underlying the urgent need for safe and highly efficacious weight loss treatments. We are delighted to see high-dose mazdutide showed a similar safety profile as low-dose mazdutide, while demonstrated more robust weight loss efficacy, as well as multiple benefits in metabolic parameters. High-dose mazdutide may offer bariatric surgery-equivalent weight loss and potentially provides an encouraging treatment option for patients with severe obesity. Based on the current data and R&D progress, I believe that mazdutide has the full potential to become an innovative anti-obesity drug buster. I am also confident that mazdutide will achieve a great success in the phase III clinical studies scheduled in the second half of this year. I hope that mazdutide can be approved and launched-to-market and benefit patients in the foreseeable future."

Dr. Lei Qian, Vice President of Clinical Development of Innovent, said "High-dose mazdutide showed favorable safety, tolerability, and robust efficacy on weight loss in Chinese adults with overweight or obesity. Mazdutide is the only molecule that achieve a 12-week weight loss by more than 11.5% among single-agent anti-obesity molecules approved or under development. This result demonstrates the superiority of GLP-1 and glucagon receptor dual agonists over GLP-1 receptor mono-agonists in terms of weight loss efficacy. Meanwhile, this study further validated the multiple metabolic benefits offered by mazdutide to patients with overweight or obesity. We will continue to develop high-dose mazdutide in overweight or obesity and other potential indications and expect more exciting results."

¹Ji L, Jiang H, An P, et al. (2021) IBI362 (LY3305677), a weekly-dose GLP-1 and glucagon receptor dual agonist, in Chinese adults with overweight or obesity: A randomised, placebo-controlled, multiple ascending dose phase 1b study. EClinicalMedicine 39: 101088. 10.1016/j.eclinm.2021.101088

China has the largest obese population in the world, with a gradual increasing trend. 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 cancer 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 the most basic treatment for patients with overweight or obesity. However, a considerable number of patients cannot achieve the desired weight loss goal due to various reasons and may use medications. Traditional anti-obesity drugs are associated with limited weight-loss effects and safety concerns.

Innovent entered into a licensing agreement with Eli Lilly and Company (Lilly) for the development and potential commercialization of OXM3 (also known as IBI362, LY3305677 or mazdutide), a GLP-1 and glucagon receptor 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 is estimated to improve glucose tolerance and induce 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.

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.

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SOURCE Innovent Biologics