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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.

Innovent Biologics (HKEX: 01801) annuncia i risultati di numerosi studi clinici su mazdutide, un agonista duale GLP-1R/GCGR, che saranno presentati al 60° Congresso Annuale EASD a Madrid, Spagna, dal 9 al 13 settembre 2024. Le presentazioni chiave includono:

1. Risultati dello studio DREAMS-2 Fase 3 che confrontano mazdutide con dulaglutide in pazienti con diabete di tipo 2.

2. Studio GLORY-1 sull'efficacia e la sicurezza di mazdutide in partecipanti cinesi in sovrappeso o obesi.

3. Analisi esplorativa del miglioramento della steatosi epatica con mazdutide in partecipanti sovrappeso o obesi.

4. Risultati dello studio di Fase 2 su mazdutide 9 mg in adulti cinesi con BMI≥30 kg/m2.

Il Dr. Lei Qian, VP dello Sviluppo Clinico, ha evidenziato che mazdutide è il primo agonista duale GLP-1R/GCGR a completare uno studio di Fase 3 per il diabete, mostrando un'efficacia superiore nella riduzione della glicemia e nella perdita di peso rispetto a dulaglutide.

Innovent Biologics (HKEX: 01801) anuncia múltiples resultados de estudios clínicos sobre mazdutide, un agonista dual GLP-1R/GCGR, que se presentarán en el 60° Congreso Anual de la EASD en Madrid, España, del 9 al 13 de septiembre de 2024. Las presentaciones clave incluyen:

1. Resultados del estudio de DREAMS-2 Fase 3 que comparan mazdutide con dulaglutida en pacientes con diabetes tipo 2.

2. Estudio GLORY-1 sobre la eficacia y seguridad de mazdutide en participantes chinos con sobrepeso u obesidad.

3. Análisis exploratorio de la mejora de la esteatosis hepática con mazdutide en participantes con sobrepeso u obesidad.

4. Resultados del estudio de Fase 2 de mazdutide 9 mg en adultos chinos con BMI≥30 kg/m2.

El Dr. Lei Qian, VP de Desarrollo Clínico, destacó que mazdutide es el primer agonista dual GLP-1R/GCGR en completar un estudio de Fase 3 para diabetes, mostrando una eficacia superior en la reducción de azúcar en sangre y pérdida de peso en comparación con dulaglutida.

Innovent Biologics (HKEX: 01801)은 mazdutide의 여러 임상 연구 결과를 발표한다고 발표했으며, 이는 2024년 9월 9일부터 13일까지 스페인 마드리드에서 열리는 EASD 제60회 연례회의에서 발표될 예정입니다. 주요 발표 내용은 다음과 같습니다:

1. 제2형 당뇨병 환자에서 mazdutide와 dulaglutide를 비교한 DREAMS-2 3상 연구 결과.

2. 과체중 또는 비만인 중국 참가자에서 mazdutide의 효능과 안전성에 대한 GLORY-1 연구.

3. 과체중 또는 비만 참가자에서 mazdutide의 간 지방증 개선의 탐색적 분석.

4. BMI≥30 kg/m2인 중국 성인에서 9mg의 mazdutide에 대한 2상 연구 결과.

임상 개발의 부사장인 Lei Qian 박사는 mazdutide가 당뇨병을 위한 3상 연구를 완료한 최초의 GLP-1R/GCGR 이중 작용제임을 강조하며 dulaglutide에 비해 혈당 감소 및 체중 감소 효능이 우수하다고 설명했습니다.

Innovent Biologics (HKEX: 01801) annonce plusieurs résultats d'études cliniques sur mazdutide, un agoniste dual GLP-1R/GCGR, qui seront présentés lors du 60e Congrès Annuel de l'EASD à Madrid, Espagne, du 9 au 13 septembre 2024. Les présentations clés incluent :

1. Résultats de l'étude DREAMS-2 Phase 3 comparant mazdutide à dulaglutide chez des patients diabétiques de type 2.

2. Étude GLORY-1 sur l'efficacité et la sécurité de mazdutide chez des participants chinois en surpoids ou obèses.

3. Analyse exploratoire de l'amélioration de la stéatose hépatique avec mazdutide chez des participants en surpoids ou obèses.

4. Résultats de l'étude de Phase 2 sur mazdutide 9 mg chez des adultes chinois avec un IMC ≥ 30 kg/m2.

Le Dr. Lei Qian, VP du Développement Clinique, a souligné que mazdutide est le premier agoniste dual GLP-1R/GCGR à avoir terminé une étude de Phase 3 pour le diabète, montrant une efficacité supérieure dans la réduction de la glycémie et de la perte de poids par rapport à dulaglutide.

Innovent Biologics (HKEX: 01801) gibt die Ergebnisse mehrerer klinischer Studien zu mazdutide, einem dualen Agonisten für GLP-1R/GCGR, bekannt, die auf dem 60. jährlichen Treffen der EASD in Madrid, Spanien, vom 9. bis 13. September 2024 präsentiert werden. Zu den wichtigsten Präsentationen gehören:

1. Ergebnisse der DREAMS-2 Phase 3 Studie, die mazdutide mit dulaglutide bei Typ-2-Diabetes-Patienten vergleicht.

2. GLORY-1 Studie zur Wirksamkeit und Sicherheit von mazdutide bei chinesischen Teilnehmern mit Übergewicht oder Fettleibigkeit.

3. Explorative Analyse der Verbesserung der Lebersteatose durch mazdutide bei übergewichtigen oder fettleibigen Teilnehmern.

4. Ergebnisse der Phase 2 Studie zu mazdutide 9 mg bei chinesischen Erwachsenen mit BMI≥30 kg/m2.

Dr. Lei Qian, VP der klinischen Entwicklung, hob hervor, dass mazdutide der erste duale Agonist für GLP-1R/GCGR ist, der eine Phase-3-Studie für Diabetes abgeschlossen hat und eine überlegene Wirksamkeit bei der Senkung des Blutzuckers und der Gewichtsreduktion im Vergleich zu dulaglutide zeigt.

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.

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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