Innovent Releases Results of a Phase 1 Clinical Study of IBI362, a Dual Glucagon-like Peptide-1 and Glucagon Receptor Agonist in Chinese Patients with Type 2 Diabetes at the International Diabetes Federation Congress 2021

Rhea-AI Summary

Innovent Biologics announced the results of a Phase 1b clinical trial for IBI362 (LY3305677), a dual GLP-1 and glucagon receptor agonist, in Chinese patients with type 2 diabetes at the International Diabetes Federation Congress 2021. The study showed IBI362 was well tolerated with a safety profile similar to dulaglutide. At week 12, mean HbA1c reductions were noted at −1.46%, −2.28%, and −1.87% for IBI362 cohorts versus −1.46% for dulaglutide. IBI362 also resulted in significant weight loss, improving metabolic parameters. Next steps include a larger Phase II trial.

Positive

• IBI362 demonstrated favorable safety and tolerability, comparable to dulaglutide.
• Significant HbA1c reductions observed: −1.46%, −2.28%, and −1.87% across dose cohorts.
• Multiple metabolic benefits including weight loss and improvements in waist circumference, blood pressure, and lipid levels.

Negative

• Limited sample size in Phase 1b study may affect the robustness of results.
• Gastrointestinal adverse events were reported, though mostly mild.

SAN FRANCISCO and SUZHOU, China, Dec. 6, 2021 /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, metabolic, autoimmune and other major diseases, announces that results of a phase 1 clinical trial of IBI362 (LY3305677), a dual glucagon-like petide-1 (GLP-1) and glucagon receptor agonist in patients with type 2 diabetes are presented as an e-poster at the International Diabetes Federation Congress 2021.

This randomized, double-blind, placebo-controlled multiple-ascending-dose phase 1b study 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 a safety profile comparable to dulaglutide. Gastrointestinal adverse events and decreased appetite were the most commonly-reported adverse events, mostly transient and mild in severity. At week 12, mean changes from baseline 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). Given the variations brought by limited sample size, after removing patients with maximum and minimum changes from baseline to week 12 in HbA1c in each dose group, the adjusted mean changes from baseline in HbA1c levels were −1.46%, −2.28% and −1.87% for patients receiving IBI362 in cohort 1,2 and 3, respectively (−1.46% for dulaglutide). Meanwhile, 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). Improvements in waist circumference, body mass index, blood pressure and lipid levels were observed in patients receiving IBI362, with overall trends similar with those observed in phase 1b study in participants with overweight or obesity^[1].

Professor Wenying Yang of China-Japan Friendship Hospital, primary investigator of the study, stated: "In recent years, GLP-1 receptor agonists have demonstrated weight loss and cardio-renal benefits to patients with diabetes while achieving glycemic control, delivering broad application prospect. We are delighted to see that IBI362, as a novel dual GLP-1 receptor and glucagon receptor agonist, has shown a favorable safety profile in Chinese patients with type 2 diabetes, together with multiple benefits of glycemic control, weight loss and metabolic profiles. These results showed the great advantage of IBI362 as a next generation GLP-1 dual agonist over mono-agonists. I am confident in the future clinical development of IBI362, and believe that IBI362 will continue to demonstrate impressive results and bring further clinical benefits in the ongoing phase II clinical trial with larger sample size and longer study duration."

Dr. Lei Qian, Executive Director of Innovent, stated: "In addition to the glycemic control efficacy of GLP-1 receptor agonism, IBI362, as a dual GLP-1 receptor and glucagon receptor agonist, may be able to promote energy expenditure by activating glucagon receptor, achieve prolonged and more pronounced weight loss compared to selective GLP-1 receptor agonists, and bring multiple metabolic benefits to patients with type 2 diabetes. Substantial weight loss has also been observed in the phase 1b clinical study of IBI362 in participants with overweight or obesity^[1]. In this 12-week phase 1b study in Chinese patients with type 2 diabetes, IBI362 showed favorable safety, significant glycemic control and weight loss, with comprehensive benefits on blood pressure, lipid levels and liver enzymes generally similar to the trends observed in the previous clinical study^[1]. We look forward to witness more robust results in subsequent clinical studies."

[1] Ji 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 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 or LY3305677), a dual GLP-1 and glucagon receptor agonist, in China. 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 is thought 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, IBI362 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 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 26 valuable assets in the fields of cancer, metabolic, autoimmune disease and other major therapeutic areas, with 6 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), a Biologics License Application (BLA) for sintilimab accepted for review in the U.S., 5 assets in Phase 3 or pivotal clinical trials, and an additional 15 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.

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.
3. For medical and healthcare professionals only.

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, 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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SOURCE Innovent Biologics

FAQ

What are the results of Innovent's Phase 1 clinical trial for IBI362?

The Phase 1b trial showed IBI362 had a favorable safety profile and significant reductions in HbA1c levels, achieving better results compared to dulaglutide.

What is IBI362 and its significance in type 2 diabetes treatment?

IBI362 is a dual GLP-1 and glucagon receptor agonist designed to improve glycemic control and promote weight loss, potentially offering extensive metabolic benefits.

What are the next steps for the development of IBI362?

Following the Phase 1b trial, Innovent plans to conduct a larger Phase II clinical trial to further evaluate IBI362's safety and efficacy.

How effective was IBI362 in reducing body weight during the trial?

The trial reported mean percent reductions in body weight of −0.9%, −5.0%, and −5.4% across the different dosing cohorts.

When and where were the results of the IBI362 trial presented?

The results of the Phase 1 clinical trial for IBI362 were presented on December 6, 2021, at the International Diabetes Federation Congress 2021.