Home Adult site Innovent Announces First Participant Received Dose in Higher-Dose Cohort of Phase 2 Clinical Trial of Mazdutide in Chinese Adults with Obesity

Innovent Announces First Participant Received Dose in Higher-Dose Cohort of Phase 2 Clinical Trial of Mazdutide in Chinese Adults with Obesity

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Rockville, Md. and SUZHOU, China, September 4, 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, autoimmune, ophthalmological diseases and other major diseases, announces first participant successfully dosed in higher dose cohort of Phase 2 clinical trial of mazdutide (R&D code: IBI362), a dual peptide 1 receptor agonist glucagon-like (GLP-1R) and glucagon receptor (GCGR) in obese Chinese adults.

This randomized, double-blind, placebo-controlled study (ClinicalTrials.gov, NCT04904913) was designed to evaluate the efficacy and safety of mazdutide in overweight or obese Chinese participants. The results for the low dose cohorts (3.0 mg, 4.5 mg and 6.0 mg) were disclosed in June this year and the primary endpoint was met. At week 24, each dose of mazdutide demonstrated significant efficacy on body weight loss compared to placebo in a dose-dependent manner and provided multiple cardio-metabolic benefits to participants; meanwhile, mazdutide was well tolerated and the overall safety profile was similar to other drugs in the same class. In addition, mazdutide titrated to 9 mg showed a good safety profile and a 12-week body weight loss of 11.7% in the phase 1b study (ClinicalTrials.gov, NCT04440345). Based on these results, Innovent will further evaluate the efficacy and safety of a higher dose (9.0 mg) of mazdutide in obese Chinese patients (BMI ≥ 30 kg/m2). A total of 80 participants are expected to be recruited and will be randomized in a 3:1 ratio to receive mazdutide 9.0 mg or placebo for 24 weeks. The primary endpoint was percent change in body weight from baseline at week 24.

Teacher Linongjithe principal investigator of the study, Peking University People’s Hospital, said: “Obesity is associated with a variety of chronic non-communicable diseases and is listed as one of the important risk factors affecting disease burden. The prevalence and growth rate of obesity in China first in the world[1], and drugs that can achieve effective and safe weight loss are therefore urgently needed in the clinic. Clinical studies of mazdutide in overweight or obese people have demonstrated significant efficacy on body weight loss and overall metabolic improvement. Treatment with mazdutide 6.0 mg for 6 months resulted in 11.6% body weight loss in participants in the low-dose cohorts of the Phase 2 study, demonstrating its best-in-class potential. I am confident that a 9.0 mg dose of mazdutide will show even more satisfactory efficacy on body weight loss and provide a new treatment option for participants with moderate to severe obesity. »

Dr. Lei Qian, Vice President of Clinical Development at Innoventsaid: “In the Phase 2 study in overweight or obese Chinese participants, low-dose mazdutide showed robust efficacy on body weight loss and multiple improvement in metabolic parameters, reflecting the potential for better class of mazdutide among GLP-1 receptors. To further expand its clinical utility, we will continue to explore the clinical benefit of mazdutide 9.0 mg in obese adults (BMI ≥ 30 kg/m2). Phase 1 study result suggests mazdutide is the first single-agent anti-obesity molecule, of any approved or in development, to achieve more than 11.5% body weight loss over 12 weeks. We hope that the higher dose mazdutide will provide a safer treatment option, similar to bariatric surgery and more accessible to obese patients. »

About overweight and obesity

China has the largest obese population in the world, with obesity rates likely to rise. Obesity can lead to a series of complications or related diseases that affect life expectancy and deteriorate quality of life. In more severe obese patients, the incidence and mortality of cardiovascular diseases, diabetes and certain tumors 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 mainstay treatment for overweight or obese patients. However, a considerable percentage of patients fail to achieve the desired weight loss goal during lifestyle intervention for a variety of reasons and may require pharmacological intervention. Traditional anti-obesity drugs have limited effects on weight loss and are associated with safety concerns.

About Mazdutide

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), a dual GLP-1R and GCGR agonist, in 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 the glucagon receptor in humans, which improves glucose tolerance and induces 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.

About Innovent

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. Building on the platform, the company has built a strong pipeline of 34 valuable assets in cancer, metabolism, autoimmune disease and other major therapeutic areas, with 7 products – TYVYT® (sintilimab injection), BYVASDA® (biosimilar injection of bevacizumab), SULINNO® (biosimilar adalimumab injection), HALPRYZA® (biosimilar rituximab injection), Pemazyre® (oral pemigatinib inhibitor), NAILIKE (olverembatinib) and Cyramza® (ramucirumab), 3 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/.

To note:

TYVYT® (sintilimab injection) is not an approved product in United States.

BYVASDA® (biosimilar injection of bevacizumab), SULINNO®and HALPRYZA® (rituximab biosimilar injection) are not approved products in United States.

TYVYT® (sintilimab injection, Innovent)

BYVASDA® (biosimilar injection of bevacizumab, Innovent)

HALPRYSA® (biosimilar injection of rituximab, 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, Eli Lilly). Cyramza® was discovered by Eli Lilly and licensed to Innovent for commercialization in mainland China.

Disclaimer:

1. This indication is still in clinical study, which has not been approved in China.

2. Innovent does not recommend any off-label use.

Forward-looking statement

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These forward-looking statements are based on the Company’s management’s existing beliefs, assumptions, expectations, estimates, projections and understandings regarding future events at the time such statements are made. These statements are not guarantees of future developments and are subject to risks, uncertainties and other factors, some of which are beyond the Company’s control and are difficult to predict. Accordingly, actual results may differ materially from the information contained in the forward-looking statements due to changes or future developments in our business, the Company’s competitive environment and political, economic, legal and social conditions.

The Company, the directors and employees of the Company assume no (a) obligation to correct or update any forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements do not materialize or prove to be incorrect.

[1] Multidisciplinary clinical consensus on the diagnosis and treatment of obesity (2021 edition). Chinese Journal of Endocrinology and Metabolism2021.37(11):959-972

SOURCE Innovative Biologics