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Innovent Announces First Patient Dosed in A Phase 1b/2 Clinical Trial of IBI362, a Dual GLP-1 and Glucagon Receptor Agonist, in China

2020-06-18 12:00 2966

SUZHOU, China, June 18, 2020 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, today announced that the first subject has been successfully dosed in a Phase 1b/2 clinical trial (CIBI362B101) of dual glucagon-like peptide 1 receptor (GLP-1R) and the glucagon receptor (GCGR) agonist (IBI362) in China.

CIBI362B101 is a multiple-dose, safety and tolerability, pharmacokinetics and pharmacodynamics clinical study of IBI362 conducted in overweight or obese subjects in China. The primary objectives of the study are to evaluate the safety and tolerability of IBI362 in overweight or obese subjects after multiple subcutaneous injections and determine a safe dose range for its clinical use.

IBI362 is a long-acting synthetic peptide related to mammalian oxyntomodulin (OXM), an endogenous hormone produced in the gut that improves glucose tolerance and causes weight loss due to effects on both food intake and energy expenditure when administered to man. Similar to OXM, IBI362 binds to and activates both the glucagon-like peptide -1 receptor (GLP-1R) and the glucagon receptor (GCGR). IBI362 uses a fatty acid side chain to prolong the duration of action and allow once-weekly administration. Simultaneously developing and activating multiple metabolism-related targets is currently the pioneering field of new drug research and development internationally for the treatment of metabolic diseases.

Professor Linong Ji of Peking University People's Hospital, stated: "Obesity has become a global health concern, and is an important cause of several chronic diseases including diabetes, cardiovascular disease, liver disease, respiratory and sleeping disorders and cancer. Approximately 50% of type 2 diabetes cases, 30% of ischemic cardiovascular and cerebrovascular diseases and 10%-40% of cancers are caused by being obese or overweight, and obesity is also listed by the World Health Organization as one of the top ten risk factors leading to disease burden. Currently, China has the largest number of overweight and obese people in the world. But at present, there is still a lack of effective therapeutic drugs to treat overweight and obese patients. As the first once-weekly dual GLP-1/GCGR receptor agonist to enter into clinical studies in China, we are looking forward to the results of its clinical study."

Dr. Qian Lei, Head of Medical Sciences and Strategies of Special Diseases of Innovent, stated: "Oxyntomodulin, along with GLP-1, is a polypeptide secreted from intestinal L-cells. In addition to activating the classical GLP-1 receptor, it also has the effect of activating the GCGR, which is expected to bring additional benefits of appetite suppression and energy expenditure. As an OXM analogue, IBI362 is a new drug with best-in-class potential worldwide. Based on previous research and development data, we believe this innovative molecule may have the potential to provide better outcomes than current GLP-1 drugs in treating metabolic conditions including obesity, fatty liver disease, and lipid metabolism."

About IBI362

Innovent entered into a licensing agreement with Eli Lilly and Company (Lilly) for the development and potential commercialization of OXM3 in China (IBI362), a dual Glucagon and GLP-1 receptor agonist. In parallel, Lilly is developing OXM3 outside China. IBI362 is a potential best-in-class dual agonist of glucagon-like peptide-1 (GLP-1) and glucagon receptor. OXM3 has the potential to be developed as an important therapy for diabetes, obesity and potentially nonalcoholic steatohepatitis (NASH), and may provide a more effective treatment regimen for overweight and obese patients.

About CIBI362B101

This is the first study to evaluate the safety, tolerability, and PK/PD of IBI362 administered as multiple injections in overweight or obese patients in China. A multicenter, randomized, double-blind and placebo-controlled trial design was used. The primary objectives of the study are to evaluate the safety and tolerability of IBI362 in overweight or obese patients after multiple subcutaneous injections and determine the safe dose range for its clinical use. The leading site of this study is Peking University People's Hospital and a total of eight clinical sites in China with strengths in developing drugs for metabolic diseases have jointly participated in this study.

About Innovent

Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop 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, metabolic, autoimmune 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 23 valuable assets in the fields of cancer, metabolic, autoimmune diseases and other major therapeutic areas, with 18 in clinical development, 5 in Phase 3 or pivotal clinical trials, 4 under NDA reviews by the NMPA (3 under priority review status), while TYVYT® (sintilimab injection), officially approved for marketing in China in 2018, has been the only PD-1 inhibitor included in the NRDL since 2019.

Innovent has built an international team of advanced talents in high-end biological drug development and commercialization, including many overseas 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 all relevant parties to help advance China's biopharmaceutical industry, improve drug availability to ordinary people and enhance the quality of the patients' lives. For more information, please visit: www.innoventbio.com.

Source: Innovent Biologics, Inc.
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