Innovent Releases Results of a Phase 1 Clinical Study of IBI362, a Glucagon-like Peptide-1 and Glucagon Receptor Dual Agonist in Overweight or Obese Chinese Participants at the American Diabetes Assoc

Innovent Biologics, Inc., a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, announces that results of a phase 1 clinical trial of IBI362, a glucagon-like petide-1 (GLP-1) and glucagon receptor dual agonist in overweight or obese Chinese participants are presented in an e-poster at the American Diabetes Association 81st Scientific Sessions.

This randomized, double-blind, placebo-controlled multiple-ascending-dose study evaluated the safety, tolerability and pharmacokinetics/pharmacodynamics characteristics of IBI362 in overweight or obese Chinese participants. Twelve participants in each of the three cohorts were randomized 2:1 to receive 1.0-2.0-3.0 mg (cohort 1), 1.5-3.0-4.5 mg (cohort 2) or 2.0-4.0-6.0 mg (cohort 3) IBI362 or placebo for 12 weeks. IBI362 was well tolerated and showed a favorable safety profile. No adverse event leading to dose interruption or dose reduction of the study drug was reported. No participant discontinued the study due to a safety reason. No serious adverse event, no hypoglycemic event and no pancreatitis was reported. Gastrointestinal adverse events and decreased appetite were the most common adverse events. At week 12, reductions in mean body weight from baseline were 3.80 kg (4.81%), 5.77 kg (6.40%) and 5.12 kg (6.05%) for participants receiving IBI362 in cohort 1, 2 and 3, respectively, compared with a 0.37 kg (0.60%) increase in participants receiving placebo (least square means using mixed effect model for repeated measures). Meanwhile, waist circumference, body mass index, blood pressure and lipid profile were also improved in participants receiving IBI362.

"Obesity is a grave public health threat with progressive increase in incidence. However, there is still a lack of effective therapeutic drugs for obese and overweight patients worldwide, which poses a great and unmet medical need. IBI362 has shown good safety, robust weight loss efficacy and multiple benefits in metabolic profile in the phase 1 clinical study, and the preliminary clinical results are very encouraging. We hope that IBI362, as a new generation of GLP-1 and glucagon receptor dual agonists, will show more inspiring results in the subsequent phase 2 clinical studies in subjects with overweight or obesity." said the Professor Linong Ji from Peking University People's Hospital and principal investigator of this study.

"IBI362 is a global innovative drug candidate. As an OXM analog, IBI362 can confer dual benefits of appetite suppression and energy expenditure through the activation of GLP-1receptor (GLP-1R) and glucagon receptor. Compared with traditional GLP-1 receptor agonists, IBI362 may not only achieve higher weight loss, but also improve the overall metabolic situation including fatty liver disease and lipid metabolism in overweight or obese people. These results suggest that IBI362 may be superior to currently available GLP-1R mono agonists for weight loss in obesity, underlining the potential benefits of targeting multiple receptors in improving metabolic disorders." said Dr. Lei Qian, Executive Director of Medical Sciences and Strategies of Special Diseases of Innovent.

About Obesity

China has the largest obese population in the world, which shows a gradually increasing trend. Obesity can lead to a range of complications or related diseases that impact life expectancy or 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 number of patients cannot achieve the desired weight loss goal due to various reasons and may use medications. Traditional anti-obesity drugs have limited weight-loss effects and safety problems.

About IBI362

Innovent entered into a licensing agreement with Eli Lilly and Company (Lilly) for the development and potential commercialization of OXM3, a GLP-1 and glucagon receptor dual agonist, in China (IBI362). In parallel, Lilly is developing OXM3 outside China. IBI362 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. IBI362, similar to the mechanism of OXM, is thought to exert its biological effects by activating glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR) in human beings, which is estimated to improve glucose tolerance and lose weight.

In addition to the effects of GLP-1R agonists on promoting insulin secretion, lowering blood glucose and reducing body weight, IBI362 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 and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong, S.A.R., China 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 24 valuable assets in the fields of cancer, metabolic, autoimmune disease and other major therapeutic areas, with 5 products – TYVYT® (sintilimab injection), BYVASDA® (bevacizumab biosimilar injection), SULINNO®(adalimumab biosimilar injection), HALPRYZA® (rituximab biosimilar injection) and PEMAZYRE® (pemigatinib oral inhibitor) – officially approved for marketing, sintilimab's Biologics License Application (BLA) acceptance in the U.S., 5 assets in Phase 3 or pivotal clinical trials, and an additional 14 molecules in clinical trials. In 2019, TYVYT® was the first PD-1 inhibitor included in the National Reimbursement Drug List (NRDL) and the only PD-1 inhibitor included in the NRDL in that year.

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. 

Note: TYVYT® (sintilimab injection)，BYVASDA® (bevacizumab biosimilar injection), SULINNO® (adalimumab biosimilar injection) and HALPRYZA® (rituximab biosimilar injection) are not approved in the United States.