ti, jun 19, 2018 08:02 CET

Key data evaluating the efficacy and safety of Farxiga (dapagliflozin) in combination with other type-2 diabetes therapies head-to-head vs. insulin or sulfonylurea

Latest data from the DEPICT clinical programme evaluating Farxiga to address an unmet need for oral therapy in adult patients with type-1 diabetes

Debut of pre-clinical and clinical data for MEDI0382 in type-2 diabetes, a potential first-in-class oxyntomodulin-like peptide

AstraZeneca and its global biologics research and development arm, MedImmune, will present 45 abstracts including seven late-breaking data disclosures from the Company’s Cardiovascular, Renal Metabolism (CVRM) therapy area at the American Diabetes Association’s (ADA) 78th Scientific Sessions in Orlando, Florida, 22-26 June 2018.

This latest research will help to inform clinical practice with Farxiga (dapagliflozin) and Bydureon (exenatide extended-release) in type-2 diabetes (T2D), including data on their use alone and in combination with other diabetes therapies. Highlights also include data on the potential new use of Farxiga in type-1 diabetes (T1D) and the debut of pre-clinical and clinical data for MEDI0382, an oxyntomodulin-like peptide and potential new medicine. MEDI0382 has the potential to be a first-in-class therapy, and is the latest candidate to advance in the Company’s CVRM pipeline.

Commenting on AstraZeneca’s scientific approach in CVRM, Ludovic Helfgott, Vice President, Cardiovascular, Renal and Metabolism, said: “At ADA this year, we are sharing data on novel approaches and potential new medicines as we continue to advance treatments for patients with diabetes. At AstraZeneca, we recognise the critical interconnectivity between cardiovascular, renal and metabolic diseases, and aim to deliver leading science that addresses patient needs across the global burden of these conditions.”

Clinical and real-world evidence data further evaluating Farxiga in T2D

Highlights include several abstracts evaluating the effects of Farxiga on glycaemic control and additional endpoints, including blood pressure and body weight, alone and in combination with other diabetes treatments across a broad range of patients.

Presentations assessing the combination of Farxiga and Onglyza (saxagliptin) include 24-week results of Farxiga as add-on therapy to Onglyza, in addition to metformin compared with insulin in patients with or without sulfonylurea therapy.

AstraZeneca will also present long-term data from the DURATION-8 trial over 104 weeks (Late-breaking Poster 104-LB), which evaluated the efficacy and safety of Farxiga once daily in combination with weekly Bydureon vs. each treatment alone.

New analyses from the EXSCEL (Exenatide Study of Cardiovascular Event Lowering) cardiovascular (CV) outcomes trial will be presented in a late-breaking poster, which will evaluate the CV and renal effects in patients that received an SGLT-2 inhibitor (SGLT-2i) in the placebo (non-exenatide) group, and a moderated poster will provide insights on the renal outcomes observed with Bydureon.

A new analysis of the landmark CVD-REAL study, presented as a late-breaking poster comparing the risk of all-cause mortality, hospitalisation for heart failure (hHF), myocardial infarction and stroke in patients with T2D starting treatment with Farxiga vs. any DPP-4 inhibitor, is based on data from Canada, Israel, Japan and South Korea. CVD-REAL provides real-world evidence of Farxiga on these CV outcomes, while DECLARE (Dapagliflozin Effect on CardiovascuLAR Events) will evaluate the CV efficacy and safety of Farxiga in the largest SGLT-2i CV outcomes trial in a broad range of patients with T2D, including those with multiple CV risk factors or established CV disease. The trial is anticipated to read out in the second half of 2018.

Data evaluating the potential of Farxiga to address an unmet need in patients with T1D

Currently, there are no oral treatment options approved for adult patients with T1D. The latest data from the DEPICT (Dapagliflozin Evaluation in Patients with Inadequately Controlled Type-1 Diabetes) clinical programme will include results on the efficacy and safety of Farxiga as add on to insulin over 52 weeks (from DEPICT-1) and 24 weeks (from DEPICT-2), as well as a pooled analysis of continuous glucose monitoring data from both trials. Farxiga is not approved for T1D.

First pre-clinical and clinical data for MEDI0382 in T2D

From the Company’s promising CVRM pipeline, MedImmune will present primary results from its MEDI0382 Phase IIa trial. MEDI0382 is an oxyntomodulin-like peptide and potential new medicine designed to simultaneously activate the glucagon-like peptide 1 (GLP-1) and glucagon (GLU) receptors, with the goals of achieving glucose control, reduced body weight and increased energy expenditure in patients with T2D. Oxyntomodulin is a peptide hormone released from the gut that targets the GLP-1 and glucagon receptors, both of which are critical to controlling metabolic functions. In addition, two oral presentations will feature data on the effects of MEDI0382 on hepatic (liver) fat in patients with T2D, and its effects on pancreatic and incretin hormones, respectively.

Details of the key abstracts from AstraZeneca/MedImmune:

The full list of AstraZeneca/MedImmune scientific data can be accessed on the ADA website here. You can also follow us live during ADA 2018 on Twitter and LinkedIn.

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NOTES TO EDITORS

About AstraZeneca in Cardiovascular, Renal Metabolism (CVRM)

Cardiovascular, renal and metabolic diseases together form one of AstraZeneca’s main therapy areas and platforms for future growth. By following the science to understand more clearly the underlying links between the heart, kidney and pancreas, AstraZeneca is investing in a portfolio of medicines to protect organs and improve outcomes by slowing disease progression, reducing risks and tackling co-morbidities. Our ambition is to modify or halt the natural course of CVRM diseases and even regenerate organs and restore function, by continuing to deliver transformative science that improves treatment practices and cardiovascular health for millions of patients worldwide.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas – Oncology, Cardiovascular, Renal Metabolism and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

For more information, please visit www.astrazeneca.com and follow us on Twitter @AstraZeneca.

About MedImmune
MedImmune is the global biologics research and development arm of AstraZeneca, a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of small molecule and biologic prescription medicines. MedImmune is pioneering innovative research and exploring novel pathways across Oncology, Respiratory, Cardiovascular, Renal and Metabolic Diseases, and Infection and Vaccines. The MedImmune headquarters is located in Gaithersburg, Md., one of AstraZeneca’s three global RD centers, with additional sites in Cambridge, UK and South San Francisco, CA. For more information, please visit www.medimmune.com.