Innovent Announces First Diabetic Patient Dosed in A Phase 1b/2 Clinical Trial of IBI362 (a Dual GLP-1 and Glucagon Receptor Agonist) in China
2020-09-18 · Innovent Biologics (Suzhou) Co. Ltd. · original innoventbio.com ↗
SAN FRANCISCO, US and SUZHOU, China, September 18, 2020 — 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 diabetic subject has been successfully dosed in a Phase 1b/2 clinical trial (CIBI362A101) of dual glucagon-like peptide 1 receptor (GLP-1R) and the glucagon receptor (GCGR) agonist (IBI362) in China. CIBI362A101 is a multiple-dose, safety and tolerability, pharmacokinetics and pharmacodynamics clinical study of IBI362 conducted in type 2 diabetic subjects with inadequate glycemic control in China. The primary objectives of the study are to evaluate the safety and tolerability of multiple subcutaneous IBI362 injections in subjects with type 2 diabetes who have inadequate control with lifestyle intervention or metformin and determine a safe dose range for its clinical use. Primary investigator, professor Wenying Yang of China-Japan Friendship Hospital, stated: " Diabetes has been a global health concern. Currently, there are many types of hypoglycemic agents for the treatment of diabetes, and each type has their advantages and disadvantages. The appropriate treatment plan should be determined according to the characteristics of patients. Novel antidiabetic drugs, represented by GLP-1 receptor agonists, have additional benefits such as weight loss, cardiovascular risk reduction, and kidney protection besides effective glycemic control. IBI362 is a dual agonist of GLP-1R and GCGR, and the synergistic effect of dual target activation may achieve more significant benefits of lowering blood glucose, body weight reduction, improvement of hepatic fat metabolism and potential cardiorenal improvement than GLP-1R. IBI362 is the first GLP-1/GCGR dual receptor agonist administered once a week to enter clinical practice in China, and we are looking forward to its clinical study results.” 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 hope this innovative molecule may have the potential to provide improvement 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 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 function of promoting insulin secretion, lowering blood glucose and reducing body weight based on the effects of GLP-1R agonists, IBI362 has been found to increase energy expenditure and improve hepatic fat metabolism through the activation of GCGR. 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. About Diabetes The prevalence of diabetes among adults in China is 11.6%. To be specific, 1 in 10 adults suffers from diabetes in average, of which type 2 diabetes accounts for about 90% of the total number of diabetic patients, and the number of patients is still increasing. Poor glycemic control will lead to irreversible microvascular and macrovascular complications such as decreased visual acuity, blindness, renal insufficiency, peripheral neuropathy, myocardial infarction, stroke, amputation, etc. As a latent disease with serious complications and high incidence, diabetes mellitus has seriously threatened human health. Currently, there are many treatment options for diabetes, and the development of new hypoglycemic drugs will also explore the additional benefits for diabetic patients in terms of weight loss, cardiovascular risk reduction, and renal protection in addition to effective glycemic control. About Innovent Biologic 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 stands out among many biopharmaceutical companies by virtue of innovative achievements and international operating models, building a robust pipeline of 23 valuable assets in the fields of cancer, metabolic, autoimmune diseases and other major therapeutic areas, of which 6 varieties were selected for the national “Major New Drug Development” project, and 3 products TYVYT® (sintilimab injection), BYVASDA® (bevacizumab injection) and SULINNO® (adalimumab injection) have been officially approved by the NMPA for marketing in China, 1 monoclonal antibody product under the priority review by NMPA, 4 in Phase 3 or pivotal clinical trials, while 15 products are in or will be in clinical development. Sintilimab has been the only PD-1 inhibitor included in the NRDL since November, 2019. Innovent has built an international team of advanced talents in high-end biological drug development and commercialization. The company has also entered into strategic collaborations with Eli Lilly and Company, Adimab, Incyte, MD Anderson Cancer Center, Hanmi, and other international partners. For more information, please visit: www.innoventbio.com. Contact: Media: [email protected] +86 512-6956 6088 Investors: [email protected] +86 512-6956 6088
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