Innovent Announces Phase 1b Study Results of Mazdutide (IBI362) in Chinese Patients with Type 2 Diabetes Published in Nature Communications

SAN FRANCISCO and SUZHOU, China, June 28, 2022 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, metabolic, ophthalmology and other major diseases, announces that phase 1b study results of mazdutide (IBI362), a glucagon-like peptide-1 (GLP-1) and glucagon receptor dual agonist, in Chinese patients with type 2 diabetes have been published in Nature Communications¹. Professor Hongwei Jiang from the First Affiliated Hospital of Henan University of Science and Technology is the first author of the article. Professor Wenying Yang from China-Japan Friendship Hospital and Dr. Lei Qian are the corresponding authors.

This randomized, double-blind, placebo-controlled multiple-ascending-dose phase 1b study (ClinicalTrials.gov: NCT04466904) evaluated the safety, tolerability and pharmacokinetics/ pharmacodynamics of IBI362 in Chinese patients with type 2 diabetes, with dulaglutide as an active control. Fourteen patients were enrolled in each of the three cohorts and randomized 8:4:2 to receive once weekly IBI362, placebo or 1.5 mg dulaglutide subcutaneously for 12 weeks. Dose escalation regimens for IBI362 and placebo were 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), with each dose level administered for 4 weeks.

IBI362 was well tolerated and showed multiple benefits of blood glucose control, weight loss and metabolic profiles.

• The most commonly-reported TEAEs were diarrhea (29.2%), decreased appetite (25.0%) and nausea (16.7%). Most gastrointestinal adverse events (diarrhea, nausea and vomiting) were mild in severity and transient. No severe treatment-emergent adverse event (TEAE) was reported.
• Least squares mean changes from baseline to week 12 in HbA1c levels were −1.46%, −2.23% and −1.66% for patients receiving IBI362 in cohort 1,2 and 3, respectively (−1.98% for dulaglutide).
• Least squares mean percent changes from baseline to week 12 in body weight were −0.9%，−5.0% and −5.4% for patients receiving IBI362 in cohort 1,2 and 3, respectively (−0.9% for dulaglutide).
• Reductions in waist circumference, body mass index, blood pressure and lipid levels, as well as improvement on insulin sensitivity were observed in patients receiving IBI362, with overall trends similar with those observed in phase 1b study in participants with overweight or obesity².

Professor Wenying Yang of China-Japan Friendship Hospital, primary investigator of the study, stated: "In recent years, GLP-1R agonists with significant glycemic control effect and multiple benefits have gained increasing attention and recommendation by both domestic and international clinical practice guidelines. We are pleased to see that IBI362, a novel GLP-1R and GCGR dual agonist, is well tolerated and safe in Chinese patients with type 2 diabetes and preliminarily exhibits effects on blood glucose reduction and body weight loss, together with multiple metabolic benefits. The results of this study got published in Nature Communications, indicating that the capability of Chinese investigators and domestic enterprises in the early clinical development of innovative drugs in the field of metabolism has been receiving international recognition. I look forward to the results of the phase II clinical study of IBI362 in Chinese subjects with type 2 diabetes, and hope that IBI362 will succeed in the upcoming phase III studies and benefit the patients as soon as possible."

Dr. Lei Qian, Vice President of Clinical Development of Innovent, stated: "IBI362 is a potent once-weekly GLP-1R and GCGR dual agonist with both blood glucose-reducing and weight loss effects, and has best-in-class potential in terms of efficacy. The phase II study of IBI362 in Chinese participants with overweight and obesity has completed with promising weight loss efficacy. The phase II study of IBI362 in Chinese patients with type 2 diabetes will complete soon. Based on the phase II results, we will actively pursue multiple registration studies of IBI362 in Chinese subjects with overweight or obesity and type 2 diabetes in the second half of this year, and look forward to accelerating the registration and launch of the product in the future."

¹ Jiang, H., Pang, S., Zhang, Y. et al. A phase 1b randomised controlled trial of a glucagon-like peptide-1 and glucagon receptor dual agonist IBI362 (LY3305677) in Chinese patients with type 2 diabetes. Nat Commun 13, 3613 (2022). https://doi.org/10.1038/s41467-022-31328-x

²Ji L, Jiang H, An P, et al. (2021) IBI362 (LY3305677), a weekly-dose GLP-1 and glucagon receptor dual agonist, in Chinese adults with overweight or obesity: A randomised, placebo-controlled, multiple ascending dose phase 1b study. EClinicalMedicine 39: 101088. 10.1016/j.eclinm.2021.101088

About Diabetes

The prevalence of diabetes among adults in China is 11.6%, 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 Mazdutide (IBI362)

Innovent entered into a licensing agreement with Eli Lilly and Company (Lilly) for the development and potential commercialization of OXM3 (also known as IBI362, LY3305677 or mazdutide), a GLP-1 and glucagon receptor dual agonist, in China. In parallel, Lilly is developing OXM3 outside China. Mazdutide 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. Mazdutide is designed to exert its biological effects by activating GLP-1 receptor and glucagon receptor in human beings, which is estimated to improve glucose tolerance and induce weight loss, mimicking the effects of endogenous oxyntomodulin.

In addition to the effects of GLP-1 receptor agonists on promoting insulin secretion, lowering blood glucose and reducing body weight, mazdutide 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, ophthalmology 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 32 valuable assets in the fields of cancer, autoimmune, metabolic, ophthalmology and other major therapeutic areas, with 7 products approved for marketing in China – TYVYT® (sintilimab injection), BYVASDA® (bevacizumab biosimilar injection), SULINNO® (adalimumab biosimilar injection), HALPRYZA® (rituximab biosimilar injection) , Pemazyre® (pemigatinib oral inhibitor) and olverembatinib (BCR-ABL TKI) and Cyramza® (ramucirumab), 3 asset under NMPA NDA review, 3 assets in Phase 3 or pivotal clinical trials, and an additional 19 molecules in clinical studies.

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. For more information, please visit: www.innoventbio.com. and www.linkedin.com/company/innovent-biologics/.

Note:

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

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

TYVYT® (sintilimab injection, Innovent)

BYVASDA® (bevacizumab biosimilar injection, Innovent)

HALPRYZA® (rituximab biosimilar injection, Innovent)

SULINNO® (adalimumab biosimilar injection, Innovent)

Pemazyre® (pemigatinib oral 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 under clinical study, which hasn't been approved in China.

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

Forward-Looking Statements

This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent Biologics, Inc. ("Innovent" or "Company") , are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly.

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions.

Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialise or turn out to be incorrect.

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