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Innovent Annouces Multiple Clinical Study Results of Mazdutide to be Presented at the EASD 2024

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Innovent Biologics (HKEX: 01801) announces multiple clinical study results of mazdutide, a GLP-1R/GCGR dual agonist, to be presented at the EASD 60th Annual Meeting in Madrid, Spain from September 9-13, 2024. Key presentations include:

1. DREAMS-2 Phase 3 study results comparing mazdutide to dulaglutide in type 2 diabetes patients.

2. GLORY-1 study on mazdutide's efficacy and safety in Chinese participants with overweight or obesity.

3. Exploratory analysis of mazdutide's improvement of liver steatosis in overweight or obese participants.

4. Phase 2 study results of mazdutide 9 mg in Chinese adults with BMI≥30 kg/m2.

Dr. Lei Qian, VP of Clinical Development, highlighted mazdutide as the first GLP-1R/GCGR dual agonist to complete a Phase 3 study for diabetes, showing superior blood sugar-lowering and weight loss efficacy compared to dulaglutide.

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Positive

  • Mazdutide is the first GLP-1R/GCGR dual agonist to complete a Phase 3 study for diabetes
  • Mazdutide demonstrated superior blood sugar-lowering and weight loss efficacy compared to dulaglutide in the DREAMS-2 Phase 3 study
  • Multiple clinical studies show consistent weight loss, glucose lowering efficacy, and metabolic benefits of mazdutide
  • Mazdutide shows improvement in liver steatosis in overweight or obese participants

Negative

  • None.

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On the day this news was published, IVBIY gained 4.76%, reflecting a moderate positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

SAN FRANCISCO and SUZHOU, China, Sept. 1, 2024 /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, cardiovascular and metabolic, ophthalmology and other major diseases, announces that multiple clinical study results of mazdutide (GLP-1R/GCGR dual agonist) will be presented at the European Association for the Study of Diabetes® (EASD) 60th Annual Meeting in Madrid, Spain from September 9 -13, 2024. New data of mazdutide at EASD include the results from the Phase 3 study of mazdutide in Chinese adults with type 2 diabetes (DREAMS-2) in late-breaking oral presentation. Details are listed below:

Title: Mazdutide vs Dulaglutide in Patients with Type 2 Diabetes (DREAMS-2): a Randomized, Open-label, 28-week Phase 3 Trial

Abstract #:LBA 16

Presentation Form:LBA Oral Presentation

Time:September 11th, 4:15 PM-4:30 PM (CEST)

Presenter:Prof. Lixin Guo, Peking Hospital

Title: Efficacy and Safety of Mazdutide in Chinese Participants with Overweight or Obesity (GLORY-1)

Abstract #:149

Presentation Form:Oral presentation

Time:September 12th, 11:45 AM-12:00 PM (CEST)

Presenter:Prof. Linong Ji, Peking University People's Hospital

Title: Improvement of Liver Steatosis by Mazdutide in Chinese Participants with Overweight or Obesity—An Exploratory Analysis of GLORY-1

Abstract #:744

Presentation Form:Short Oral Presentation

Time:September 10th, 12:30 PM (CEST)

Presenter:Prof. Leili Gao Peking University People's Hospital

Title: A Phase 2 Study of Mazdutide 9 mg in Chinese Adults with BMI≥30 kg/m2

Abstract #:733

Presentation Form:Short Oral Presentation

Time:September 12th, 2:00 PM (CEST)

Presenter:Prof. Hongwei Jiang, the First Affiliated Hospital of Henan University of Science and Technology

Dr. Lei Qian, Vice President of Clinical Development of Innovent, stated, "We are delighted that the results of the Phase 3 study DREAMS-2 for mazdutide in T2D will be presented in the form of a late-breaking oral presentation at the EASD annual meeting. Mazdutide is the first GLP-1R/GCGR dual agonist to successfully complete a Phase 3 study for diabetes, demonstrating superior blood sugar-lowering and weight loss efficacy compared to dulaglutide. Of equal importance, a number of weight loss study data of mazdutide, including the GLORY-1 Phase 3 study, the 9 mg Phase 2 study will also be showcased at this EASD conference. The weight loss and glucose lowering efficacy and metabolic benefits of mazdutide, especially in the liver, have been consistently observed and further validated across clinical trials and patient populations."

About Mazdutide (IBI362)
Innovent entered into an exclusive license agreement with Eli Lilly and Company (Lilly) for the development and potential commercialization of OXM3 (also known as mazdutide), a GLP-1R and GCGR dual agonist, in China. As a mammalian oxyntomodulin (OXM) analogue, mazdutide promotes insulin secretion, lowers blood glucose and reduces body weight similar to GLP-1 receptor agonists. Additionally, it may increase energy expenditure and improve hepatic fat metabolism by activating the glucagon receptor. Mazdutide has strong efficacy in weight loss and lowering glucose levels in clinical studies. It also offers multiple cardio-metabolic benefits, such as reducing waist circumference, blood lipids, blood pressure, blood uric acid, liver enzymes, and liver fat content, while improving insulin sensitivity.

Mazdutide has two NDAs accepted by China's NMPA for review, including:

  • For the chronic weight management in adults with obesity or overweight;
  • For the glycemic control in adults with type 2 diabetes.

Currently, a total of five Phase 3 studies of mazdutide are underway, including:

  • Phase 3 study conducted in Chinese adults with overweight or obesity (GLORY-1);
  • Phase 3 study conducted in Chinese adults with moderate to severe obesity (GLORY-2);
  • Phase 3 study in newly treated Chinese patients with type 2 diabetes (DREAMS-1);
  • Phase 3 study comparing mazdutide and dulaglutide in Chinese patients with type 2 diabetes (DREAMS-2);
  • Phase 3 study comparing mazdutide and semaglutide in Chinese patients with type 2 diabetes and obesity (DREAMS-3).

Among them, GLORY-1, DREAMS-1 and DREAMS-2 have reached the study endpoints and successfully completed.

About Innovent
Innovent is a leading biopharmaceutical company founded in 2011 with the mission to provide high-quality biologics that are affordable to all. The company discovers, develops, manufactures and commercializes innovative medicines that treat some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has 11 products in the market, 3 new drug applications under the NMPA review, 4 assets in Phase III or pivotal clinical trials and 18 more molecules in early clinical stage. Innovent partners with over 30 global healthcare leaders, including Eli Lilly, Roche, Sanofi, Adimab, Incyte and MD Anderson Cancer Center.

Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit www.innoventbio.com, or follow Innovent on Facebook and LinkedIn.

Statement: Innovent does not recommend the use of any unapproved drug (s)/indication (s).

Forward-looking statement
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 ("Innovent"), are intended to identify certain of such forward-looking statements. The Company 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 the Company 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 the Company'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, the Company's competitive environment and political, economic, legal and social conditions.

The Company, the Directors and the employees of the Company 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 materialize or is otherwise inaccurate.

 

Cision View original content:https://www.prnewswire.com/news-releases/innovent-annouces-multiple-clinical-study-results-of-mazdutide-to-be-presented-at-the-easd-2024-302235586.html

SOURCE Innovent Biologics

FAQ

What are the key clinical studies of mazdutide (IVBIY) presented at EASD 2024?

The key clinical studies of mazdutide presented at EASD 2024 include the DREAMS-2 Phase 3 study comparing mazdutide to dulaglutide in type 2 diabetes, the GLORY-1 study on efficacy and safety in overweight or obese participants, an exploratory analysis on liver steatosis improvement, and a Phase 2 study of mazdutide 9 mg in adults with BMI≥30 kg/m2.

What are the main findings of the DREAMS-2 Phase 3 study for mazdutide (IVBIY)?

The DREAMS-2 Phase 3 study demonstrated that mazdutide, as the first GLP-1R/GCGR dual agonist to complete a Phase 3 study for diabetes, showed superior blood sugar-lowering and weight loss efficacy compared to dulaglutide in patients with type 2 diabetes.

When and where will the mazdutide (IVBIY) clinical study results be presented?

The mazdutide clinical study results will be presented at the European Association for the Study of Diabetes (EASD) 60th Annual Meeting in Madrid, Spain from September 9-13, 2024.

What additional benefits of mazdutide (IVBIY) were observed in the clinical studies?

In addition to blood sugar-lowering and weight loss efficacy, the clinical studies showed that mazdutide demonstrated metabolic benefits, particularly in improving liver steatosis in overweight or obese participants.
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