Rockville, Md. and SUZHOU, China, October 16, 2022 /PRNewswire/ — Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and markets high-quality drugs for the treatment of oncology, metabolic diseases, autoimmune and other major diseases, announced that the results of the higher dose cohorts in a phase 1b A study of mazdutide (IBI362), a glucagon-like peptide-1 (GLP-1) and dual glucagon receptor agonist, in overweight or obese Chinese participants has been published online in eClinicalMedicine (https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(22)00421-7/fulltext). Teacher Linongji and teacher Leili Gao from Peking University People’s Hospital are the first co-authors of the article. Teacher Linongji and Dr. Lei Qian are the corresponding authors.
This randomized, placebo-controlled, multiple-escalation-dose study evaluated the safety, tolerability, and pharmacokinetic/pharmacodynamic characteristics of mazdutide in overweight or obese Chinese participants (NCT04440345). The results of the low dose cohorts (3 mg, 4.5 mg and 6.0 mg) have been published in eClinicalMedicine in August 20211. In the higher dose cohorts, 12 participants from each cohort were randomized 2:1 to receive 2.5-5.0-7.5-10.0 mg subcutaneous (10 mg cohort) or 3.0 -6.0-9.0 mg (9 mg cohort) of mazdutide or placebo once weekly, with each dose level given for 4 weeks.
In the higher dose cohorts, mazdutide increased to 10 mg and 9 mg was well tolerated. No participant discontinued the study due to adverse events. No serious adverse events or serious adverse events were reported. The most commonly reported treatment-related adverse events were gastrointestinal adverse events, generally of mild severity. At week 16, the mean reduction (percentage reduction) in body weight from baseline was 7.62 kg (9.5%) for participants receiving mazdutide in the 10 mg cohort. At week 12, the mean reduction (percent reduction) in body weight from baseline was 9.23 kg (11.7%) for participants receiving mazdutide in the 9 mg cohort. Improvements in BMI, waist circumference, blood pressure, lipids, and serum uric acid were similar to those seen in the low-dose cohorts.
Several clinical studies of mazdutide are ongoing, including 1) the higher dose cohort of a phase II study of mazdutide in obese Chinese adults, with the first participant receiving the dosage in September 2022 and 2) an initiated Phase III clinical study in overweight or obese Chinese adults, which received IND approval in October 2022.
Teacher Linongji the principal investigator of this study, Peking University People’s Hospital, said: “We are delighted that the results of the higher dose mazdutide in phase 1b study has just been published. The higher dose mazdutide has shown favorable tolerability and safety profiles, as well as rapid and robust weight loss efficacy, and has the potential to provide patients with severe obesity with treatment options comparable to the effectiveness of bariatric surgery. Combined with the results of the Phase I and Phase II studies of low-dose mazdutide, mazdutide has the potential to become one of the most potent innovative anti-obesity drugs in the world. I am hopeful that mazdutide will achieve great success in phase III clinical studies and demonstrate benefits to patients as soon as possible. »
Dr. Lei Qian, Vice President of Clinical Development at Innovent, said, “The release of Phase I results from the mazdutide 9mg and 10mg cohorts further reflects the efficiency and translational collaboration between Chinese biopharmaceuticals and academia in the early clinical development of innovative metabolic drugs. The results of the higher dose mazdutide make it the world’s first monotherapy anti-obesity drug to achieve more than 11.5% body weight loss over 12 weeks. We expect more encouraging results from the ongoing Phase II clinical study of mazdutide 9mg, which will lay a solid foundation. for its potential as an alternative therapy to bariatric surgery. Mazdutide’s phase III studies are ongoing and we expect it to provide entirely new treatment options for overweight and obese Chinese patients in the near future.
1Ji L, Jiang H, An P, et al. (2021) IBI362 (LY3305677), a weekly-dose GLP-1 and glucagon dual agonist, in overweight or obese Chinese adults: a randomized, placebo-controlled, multiple ascending dose phase 1b study. ECMedicineClinical 39: 101088.10.1016/j.eclinm.2021.101088
China has the largest obese population in the world, with a gradual upward trend. Obesity can lead to a series of complications or related diseases that impact life expectancy and lead to a decrease in quality of life. In more severe obese patients, the incidence and mortality of cardiovascular diseases, diabetes and certain cancers increase significantly. Obesity is a chronic disease that requires long-term management, and there is a lack of effective and safe long-term treatments. Lifestyle intervention is the first choice and most basic treatment for overweight or obese patients. However, a considerable number of patients cannot achieve the desired weight loss goal for various reasons and may use medication. Traditional anti-obesity drugs are associated with limited weight loss effects and safety concerns.
Innovent has entered into a licensing agreement with Eli Lilly and Company (Lilly) for the development and potential commercialization of OXM3 (also known as Mazdutide, IBI362 or LY3305677), a dual GLP-1 receptor and glucagon China. In parallel, Lilly is developing OXM3 outside China. Mazdutide is a synthetic, long-acting peptide related to mammalian oxyntomodulin (OXM), which utilizes a fatty acid side chain to prolong the duration of action and allow for once-weekly administration. Mazdutide is thought to exert its biological effects by activating the GLP-1 receptor and glucagon receptor in humans, which is believed to improve glucose tolerance and induce weight loss, mimicking the effects of endogenous oxyntomodulin .
In addition to the effects of GLP-1 receptor agonists in promoting insulin secretion, lowering blood sugar, and reducing body weight, mazdutide may also increase energy expenditure and improve hepatic fat metabolism through glucagon receptor activation. Treating metabolic diseases by simultaneously activating multiple metabolic-related targets is currently the global trend in drug development.
Inspired by the spirit “Begin with Integrity, Succeed with Action”, Innovent’s mission is to develop, manufacture and market high-quality biopharmaceutical products that are affordable for everyday people. Founded in 2011, Innovent is committed to developing, manufacturing and marketing high-quality, innovative medicines for the treatment of cancer, autoimmune, metabolic, ophthalmological and other major diseases. On October 31, 2018Innovent was listed on the main board of the Stock Exchange of Hong Kong Limited with stock code: 01801.HK.
Since its creation, Innovent has developed a fully integrated multifunctional platform that includes R&D, CMC (chemistry, manufacturing and controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a robust pipeline of 34 valuable assets in cancer, metabolism, autoimmune disease and other major therapeutic areas, with 8 products approved for commercialization in China – TYVYT® (sintilimab injection), BYVASDA® (bevacizumab biosimilar injection), SULINNO® (adalimumab biosimilar injection), HALPRYZA® (rituximab biosimilar injection), Pemazyre® (oral pemigatinib inhibitor), olverembatinib (BCR ABL TKI), CYRAMZA® ( ramucirumab) and selpercatinib, 2 assets under NMPA NDA review, 4 assets in Phase 3 or pivotal clinical trials, and 20 additional molecules in clinical studies.
Innovent has assembled an international team with advanced talents in the development and commercialization of high-end biologic drugs, including many global experts. The company has also entered into strategic collaborations with Eli Lilly and Company, Sanofi, Adimab, Incyte, MD Anderson Cancer Center and other international partners. Innovent strives to work with many collaborators to advance China the biopharmaceutical industry, improve the availability of drugs and improve the quality of life of patients. For more information, please visit: www.innoventbio.com. and www.linkedin.com/company/innovent-biologics/.
TYVYT® (sintilimab injection) is not an approved product in United States.
BYVASDA® (biosimilar injection of bevacizumab), SULINNO® and HALPRYZA® (biosimilar injection of rituximab) are not approved products in United States.
TYVYT® (sintilimab injection, Innovent)
BYVASDA® (biosimilar injection of bevacizumab, Innovent)
HALPRYZA® (rituximab biosimilar injection, Innovent)
SULINNO® (biosimilar injection of adalimumab, Innovent)
Pemazyre® (oral pemigatinib 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, Lilly). CYRAMZA® was discovered and developed by Lilly and licensed to Innovent for commercialization in mainland China.
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SOURCE Innovative Biologics