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Regulatoriskt pressmeddelande

AstraZeneca presents further data showing the interconnectivity between cardiovascular and renal risks in diabetes at EASD 2018

AstraZeneca
Läs börsmeddelandet

AstraZeneca and MedImmune, its global biologics research and development arm, will present more than 50 abstracts from the Company's Cardiovascular, Renal & Metabolism (CVRM) therapy area at the 54th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Berlin, Germany, 1-5 October 2018.

This latest research underscores AstraZeneca's expansive clinical trial programme and comprehensive approach to advancing clinical practice in the management of cardiovascular, renal and metabolic (CaReMe) diseases. Data to be presented from the Company's broad portfolio include Farxiga (dapagliflozin) and Bydureon (exenatide extended-release) in type-2 diabetes (T2D), alone and in combination with other diabetes therapies. Highlights also include data on the potential of Farxiga in type-1 diabetes (T1D) and additional pre-clinical and clinical data for MEDI0382, a potential first-in-class oxyntomodulin-like peptide for type-2 diabetes and the latest candidate in the Company's CVRM pipeline.

Ludovic Helfgott, Vice President, Cardiovascular, Renal and Metabolism at AstraZeneca, said: "Our key data at EASD will expand understanding around the persistent cardiovascular and renal risks in patients with type-2 diabetes, as well as the unmet need in type-1 diabetes, where we are at the forefront of advancing treatment for patients. We are constantly pursuing science to advance the management of cardiovascular, renal and metabolic diseases to improve patient outcomes."

New data to highlight the potential of Farxiga in T2D and interconnectivity between CV and renal diseases

Highlights include several abstracts evaluating the effects of Farxiga alone and in combination in treating T2D, and in patients with CV (including heart failure) and renal risk factors. Research into CaReMe diseases includes a recent trial on CV outcomes and mortality in people with T2D and associated comorbidities (Poster #1177). The results will illustrate the importance of identifying novel protection strategies for various T2D-related comorbidities, including heart failure and chronic kidney disease, and may have implications for investigating risk in T2D patients.

A further presentation will include 52-week results of Farxiga as an add-on therapy to Onglyza (saxagliptin) in addition to metformin, compared with insulin in patients with or without sulfonylurea therapy.

For patients with T1D, insulin is the standard therapy with no oral treatment options approved to date. The latest sub-analysis (Poster #612) of pooled data from the DEPICT (Dapagliflozin Evaluation in Patients with Inadequately Controlled Type-1 Diabetes) clinical trial programme (DEPICT-1 and DEPICT-2) features an evaluation on the effect of Farxiga in T1D patients taking adjustable insulin treatment. The analysis will look at two composite endpoints, including those determining instances of weight gain, severe hypoglycaemia and diabetic ketoacidosis (DKA). Farxiga is currently not approved in T1D.

AstraZeneca will also present an analysis from the CVD-REAL study (Poster #635) which evaluated the efficacy and safety of SGLT2 inhibitors vs. other glucose-lowering medicines. This additional analysis will look at data across a larger number of countries and patients, with a longer duration of follow up than previously evaluated.

Comprehensive new analyses of the safety and efficacy of Bydureon

Results will also be presented from 10 randomised Phase III, 24-to-30-week clinical trials within the DURATION programme (Poster #737), which evaluated the safety and efficacy of glucagon-like peptide-1 (GLP-1) receptor agonist Bydureon, administered once-weekly either subcutaneously or with an autoinjector, in patients with T2D.

Advancing a potential first-in-class approach to T2D with MEDI0382

From the Company's promising CVRM pipeline, there will be an oral presentation of data from a Phase IIa trial on the observed effects of MEDI0382 on glucose control and weight loss in patients with T2D (Presentation #164). MEDI0382 is an oxyntomodulin-like peptide and potential new medicine designed to simultaneously activate the GLP-1 and glucagon (GLU) receptors, with the goal of achieving glucose control, reduced body weight and increased energy expenditure in patients with T2D.

Details of the key abstracts from AstraZeneca/MedImmune at EASD 2018:

+--------------+---------------------------------------------------------------+
|Abstract title|Presentation details |
+--------------+---------------------------------------------------------------+
|Farxiga |
+--------------+---------------------------------------------------------------+
|Effects of |Poster #653 |
|dapagliflozin |Tuesday Oct 2, 12:00 PM - 1:00 PM |
|on urine and |Poster Session: PS 049 Novel aspects of SGLT2 inhibitors |
|plasma | |
|metabolome in | |
|patients with | |
|type 2 | |
|diabetes: | |
|preliminary | |
|results | |
+--------------+---------------------------------------------------------------+
|Pooled data |Poster #612 |
|analysis of |Tuesday Oct 2, 1:15 PM - 2:15 PM |
|composite |Poster Session: PS 044 Are SGLT2 inhibitors effective and safe |
|endpoints from|in type 1 diabetes? |
|the DEPICT-1 | |
|and DEPICT-2 | |
|studies using | |
|dapagliflozin | |
|compared to | |
|placebo added | |
|to adjustable | |
|insulin in | |
|type 1 | |
|diabetes | |
+--------------+---------------------------------------------------------------+
|Pooled |Poster #613 |
|analysis of |Tuesday Oct 2, 1:15 PM - 2:15 PM |
|the duration |Poster Session: PS 044 Are SGLT2 inhibitors effective and safe |
|of type 1 |in type 1 diabetes? |
|diabetes in | |
|dapagliflozin | |
|vs placebo on | |
|adjustable | |
|insulin | |
|therapy from | |
|DEPICT 1 and | |
|2: effects on | |
|glycaemia, | |
|weight and | |
|insulin dosage| |
+--------------+---------------------------------------------------------------+
|Dapagliflozin |Poster #617 |
|preserves |Wednesday Oct 3, 12:00 PM - 1:00 PM |
|renal function|Poster Session: PS 045 Microvascular effects of SGLT2 |
|in patients |inhibitors: focus on kidneys and eyes |
|with T2DM: a | |
|longitudinal | |
|meta-analysis | |
|of eGFR in | |
|clinical | |
|trials | |
+--------------+---------------------------------------------------------------+
|Effect of |Poster #619 |
|dapagliflozin |Wednesday Oct 3, 12:00 PM - 1:00 PM |
|on renal and |Poster Session: PS 045 Microvascular effects of SGLT2 |
|cardiac |inhibitors: focus on kidneys and eyes |
|function in | |
|patients with | |
|type 2 | |
|diabetes and | |
|albuminuria - | |
|a randomized | |
|study | |
+--------------+---------------------------------------------------------------+
|Efficacy of |Poster #775 |
|dapagliflozin |Wednesday Oct 3, 12:00 PM - 1:00 PM |
|plus |Poster Session: PS 063 DPP4 inhibitors: new regiments and new |
|saxagliptin vs|comparisons |
|insulin | |
|glargine at 52| |
|weeks in | |
|patients with | |
|type 2 | |
|diabetes | |
|inadequately | |
|controlled by | |
|metformin with| |
|or without | |
|sulfonylurea | |
+--------------+---------------------------------------------------------------+
|Effect of |Poster #622 |
|dapagliflozin |Wednesday Oct 3, 12:00 PM - 1:00 PM |
|(DAPA) on |Poster Session: PS 045 Microvascular effects of SGLT2 |
|cardiovascular|inhibitors: focus on kidneys and eyes |
|and renal risk| |
|factors in | |
|patients with | |
|type 2 | |
|diabetes | |
|treated with | |
|or without | |
|renin | |
|-angiotensin | |
|system | |
|inhibitors | |
|(RASi) | |
+--------------+---------------------------------------------------------------+
|Durability of |Poster #830 |
|improved |Wednesday Oct 3, 1:15 PM - 2:15 PM |
|patient |Poster Session: PS 070 Clinical outcomes in insulin treated |
|-reported |patients |
|outcomes in | |
|type 2 | |
|diabetes | |
|patients | |
|treated with | |
|dapagliflozin | |
|plus | |
|saxagliptin vs| |
|insulin | |
|glargine | |
+--------------+---------------------------------------------------------------+
|New SGLT-2i |Presentation #113 |
|versus bolus |Wednesday Oct 3, 2:30 PM - 4:00 PM |
|insulin users |Session: OP 19 SGLT2 inhibitors: new mechanisms and clinical |
|as add-on to |evidence (the Langerhans Hall) |
|stable basal | |
|insulin | |
|treatment in | |
|T2D and | |
|associated | |
|risks of | |
|cardiovascular| |
|disease and | |
|mortality: an | |
|observational | |
|stud | |
+--------------+---------------------------------------------------------------+
|Lower |Poster #635. |
|cardiovascular|Thursday Oct 4, 12:00 PM - 1:00 PM |
|risk with SGLT|Poster Session: PS 047 SGLT2 inhibitors around the world: |
|-2 inhibitors |evidence from clinical trials and registries |
|vs other | |
|glucose | |
|-lowering | |
|drugs - real | |
|world data | |
|from Asia | |
|Pacific, North| |
|America, | |
|Europe and | |
|Middle East: | |
|the CVD-REAL | |
|study | |
+--------------+---------------------------------------------------------------+
|DAPADream: |Poster #640 |
|improvement of|Thursday Oct 4, 1:15 PM - 2:15 PM |
|time in range |Poster Session: PS 048 Glycaemic and metabolic effects of SGLT2|
|after SGLT2 |inhibitors |
|-add-on | |
|-medication in| |
|youth and | |
|young adults | |
|with T1D | |
|during | |
|unannounced | |
|meals under | |
|full closed | |
|loop CSII | |
+--------------+---------------------------------------------------------------+
|Dapagliflozin |Poster #647 |
|plus |Thursday Oct 4, 1:15 PM - 2:15 PM |
|saxagliptin |Poster Session: PS 048 Glycaemic and metabolic effects of SGLT2|
|add-on to |inhibitors |
|metformin | |
|reduces liver | |
|fat and | |
|adipose tissue| |
|volume in | |
|patients with | |
|type 2 | |
|diabetes | |
+--------------+---------------------------------------------------------------+

+--------------+------------------------------------------------------------+
|Bydureon |
+--------------+------------------------------------------------------------+
|DURATION-8 |Presentation #37 |
|randomised |Langerhans Hall |
|controlled |Tuesday Oct 2, 2:30 PM - 4:00 PM |
|trial 104-week|Presentation: OP 07 New insights from clinical trials with |
|results: |incretin-based therapies |
|efficacy and | |
|safety of once| |
|-weekly | |
|exenatide | |
|(ExQW) plus | |
|once-daily | |
|dapagliflozin | |
|(DAPA) versus | |
|ExQW or DAPA | |
|alone | |
+--------------+------------------------------------------------------------+
|Potential |Presentation #40 |
|impact of |Langerhans Hall |
|differential |Tuesday Oct 2, 2:30 PM - 4:00 PM |
|drop-in of |Presentation: OP 07 New insights from clinical trials with |
|open-label |incretin-based therapies |
|diabetes | |
|medications in| |
|EXSCEL | |
+--------------+------------------------------------------------------------+
|Cardiovascular|Presentation #73 |
|safety and |Langerhans Hall |
|efficacy of |Wednesday Oct 3, 10:15 AM - 11:45 AM |
|exenatide once|Presentation: OP 13 GLP1 receptor agonists, SGLT2 inhibitors|
|-weekly in |and the kidney: new lessons from large clinical trials |
|patients with | |
|moderate renal| |
|dysfunction in| |
|the EXenatide | |
|Study of | |
|Cardiovascular| |
|Event Lowering| |
|(EXSCEL) | |
+--------------+------------------------------------------------------------+
|Effect of the |Poster #721 |
|exenatide plus|Wednesday Oct 3, 12:00 PM - 1:00 PM |
|dapagliflozin |Poster Session: PS 057 Lipids and fatty liver: What GLP1 |
|combination on|receptor agonists can do |
|fatty liver | |
|index and | |
|insulin | |
|resistance in | |
|type 2 | |
|diabetes | |
|mellitus | |
|patients: the | |
|DURATION-8 | |
|trial | |
+--------------+------------------------------------------------------------+
|Efficacy and |Poster #737 |
|safety with |Thursday Oct 4, 12:00 PM - 1:00 PM |
|exenatide once|Poster Session: PS 059 On the efficacy of GLP1 receptor |
|weekly: |agonists |
|clinical trial| |
|results from | |
|10 randomised | |
|trials (the | |
|DURATION | |
|programme) | |
+--------------+------------------------------------------------------------+

+-------------+-----------------------------------------+
|MEDI0382 |
+-------------+-----------------------------------------+
|MEDI0382, a |Poster #605 |
|GLP |Tuesday Oct 2, 12:00 PM - 1:00 PM |
|-1/glucagon |Poster Session: PS 043 Weight regulation |
|receptor dual|and obesity in humans and rodent models |
|agonist, | |
|reduces | |
|weight and | |
|improves | |
|metabolism | |
|via central | |
|and | |
|peripheral | |
|actions | |
+-------------+-----------------------------------------+
|MEDI0382, a |Poster #718 |
|glucagon-like|Tuesday Oct 2, 1:15 PM - 2:15 PM |
|peptide |Poster Session: PS 056 Metabolic effects |
|1/glucagon |of novel, dual and triple incretin |
|receptor dual|agonists |
|agonist, in | |
|patients with| |
|type 2 | |
|diabetes: a | |
|multiple | |
|-ascending | |
|-dose study | |
+-------------+-----------------------------------------+
|MEDI0382, a |Poster #1210 |
|GLP |Wednesday Oct 3, 12:00 PM - 1:00 PM |
|-1/glucagon |Poster Session: PS 117 Treating NAFLD |
|receptor dual| |
|agonist, | |
|improves NASH| |
|and reduces | |
|liver | |
|fibrosis in | |
|mice | |
+-------------+-----------------------------------------+
|MEDI0382, a |Poster #727 |
|glucagon-like|Wednesday Oct 3, 12:00 PM - 1:00 PM |
|peptide |Poster Session: PS 057 Lipids and fatty |
|1/glucagon |liver: What GLP1 receptor agonists can do|
|receptor dual| |
|agonist, | |
|significantly| |
|reduces | |
|hepatic fat | |
|content in | |
|subjects with| |
|type 2 | |
|diabetes | |
|mellitus | |
+-------------+-----------------------------------------+
|Effects of |Poster #778 |
|MEDI0382, a |Wednesday Oct 3, 1:15 PM - 2:15 PM |
|glucagon-like|Poster Session: PS 064 Incretin-based |
|peptide |therapies: new mechanistic insights |
|1/glucagon | |
|receptor dual| |
|agonist, on | |
|pancreatic | |
|and incretin | |
|hormones | |
+-------------+-----------------------------------------+
|MEDI0382, a |Presentation #164 |
|dual GLP-1 |Thursday Oct 4, 10:15 AM - 11:45 AM |
|glucagon |Presentation: OP 28 Novel drug therapies:|
|receptor |moving beyond GLP1 |
|agonist, | |
|promotes | |
|rapid glucose| |
|control and | |
|significant | |
|weight loss | |
|in patients | |
|with type 2 | |
|diabetes | |
+-------------+-----------------------------------------+
|Robust |Poster #743 |
|glucose |Thursday Oct 4, 12:00 PM - 1:00 PM |
|control and |Poster Session: PS 059 On the efficacy of|
|weight loss |GLP1 receptor agonists |
|after 6 weeks| |
|of treatment | |
|with | |
|MEDI0382, a | |
|balanced GLP | |
|-1/glucagon | |
|receptor dual| |
|agonist, in | |
|patients with| |
|type 2 | |
|diabetes | |
+-------------+-----------------------------------------+

+---------------+-----------------------------------+
|General |
|diabetes |
+---------------+-----------------------------------+
|Quality of |Poster #344 |
|life in |Thursday Oct 4, 12:00 PM - 1:00 PM |
|patients with |Poster Session: PS 011 Type 2 |
|type 2 |diabetes therapy intensification |
|diabetes | |
|initiating a | |
|second-line | |
|glucose | |
|-lowering | |
|therapy: the | |
|global | |
|DISCOVER study | |
+---------------+-----------------------------------+
|Change over 12 |Poster #294 |
|months in |Wednesday Oct 3, 1:15 PM - 2:15 PM |
|HbA1c, fasting |Poster Session: PS 004 Diabetes: |
|plasma glucose |therapeutic approaches |
|and weight | |
|among patients | |
|with type 2 | |
|diabetes in 37 | |
|countries: | |
|DISCOVER | |
+---------------+-----------------------------------+
|Global |Poster #854 |
|patterns of |Tuesday Oct 2, 12:00 PM - 1:00 PM |
|cardiovascular |Poster Session: PS 073 Diabetes |
|risk factor |control around the world |
|control in | |
|patients with | |
|type 2 | |
|diabetes | |
|mellitus: | |
|insights from | |
|the global | |
|DISCOVER study | |
+---------------+-----------------------------------+
|Second-line |Poster #345 |
|glucose |Thursday Oct 4, 12:00 PM - 1:00 PM |
|-lowering |Poster Session: PS 011 Type 2 |
|therapies as |diabetes therapy intensification |
|chosen by | |
|cardiologists | |
|versus con | |
|-cardiologists:| |
|an analysis of | |
|the Diabetes | |
|Collaborative | |
|Registry | |
+---------------+-----------------------------------+
|Eligibility |Poster #1151 |
|varies across |Tuesday Oct 2, 1:15 PM - 2:15 PM |
|the 4 sodium |Poster Session: PS 110 Treating |
|-glucose |cardiovascular disease in diabetes |
|cotransporter | |
|-2 inhibitor | |
|cardiovascular | |
|outcomes | |
|trials among | |
|adults with | |
|type 2 | |
|diabetes: | |
|implications | |
|from the | |
|Diabetes | |
|Collaborative | |
|Registry | |
+---------------+-----------------------------------+
|Cardiovascular |Poster #1177 |
|outcomes and |Thursday Oct 4, 12:00 PM - 1:00 PM |
|mortality in |Poster Session: PS 113 Epidemiology|
|type 2 |of cardiovascular disease and |
|diabetes with |diabetes |
|associated | |
|cardio-renal | |
|-metabolic | |
|comorbidities | |
+---------------+-----------------------------------+

+-----------------+-------------------------------------+
|Early science |
+-----------------+-------------------------------------+
|A novel human |Presentation #104 |
|pluripotent stem |Wednesday Oct 3, 10:15 AM -11:45 AM |
|cell (HPSC) |Presentation: OP 18 From stem cells |
|derived alpha |to human pancreas development |
|-cell model that | |
|behaves like | |
|primary cells in | |
|vitro and in vivo| |
+-----------------+-------------------------------------+
|Pharmacological |Poster #483 |
|characterisation |Wednesday Oct 3, 1:15 PM - 2:15 PM |
|of an ultra-long |Poster Session: PS 028 Balancing the |
|acting once |books: insulin delivery and clearance|
|weekly Insulin-Fc| |
|fusion with | |
|continuous | |
|glucose | |
|monitoring | |
+-----------------+-------------------------------------+
|MEDI4166, an |Presentation #166 |
|antibody-peptide |Heubner Hall |
|fusion molecule: |Thursday Oct 4, 10:15 AM - 11:45 AM |
|multiple |Presentation: OP 28 Novel drug |
|-ascending-dose |therapies: moving beyond GLP1 |
|study in patients| |
|with type 2 | |
|diabetes mellitus| |
+-----------------+-------------------------------------+
|A novel |Poster #491 |
|preclinical model|Thursday Oct 4, 12:00 PM - 1:00 PM |
|to define the |Poster Session: PS 029 Visit to the |
|window between |diabetes zoo: novel animal models |
|plasma glucose | |
|lowering versus | |
|water retention | |
|in the gut during| |
|SGLT1 inhibition | |
+-----------------+-------------------------------------+
|The dual PPARα/γ |Presentation #200 |
|-agonist |Thursday Oct 4, 2:45 PM - 3:00 PM |
|tesaglitazar |Presentation: OP 34 Novelty in |
|robustly induces |adipose tissue biology and lipid |
|browning of white|metabolism |
|fat in vitro and | |
|in vivo | |
+-----------------+-------------------------------------+
|Novel FGF family |Presentation #190 |
|members may |Thursday Oct 4, 3:15 PM - 3:30 PM |
|represent drivers|Presentation: OP 32 Beta cells stick |
|of β-cell |together to fight insulin resistance |
|dedifferentiation| |
|in T2D | |
+-----------------+-------------------------------------+
|Bottom-up islet |Presentation #237 |
|engineering |Friday Oct 5, 9:45 AM - 10:45 AM |
| |Presentation: OP 42 Intercellular |
| |interactions and islet function |
+-----------------+-------------------------------------+

The full list of AstraZeneca/MedImmune scientific data can be accessed on the EASD website here (https://upload.easd.org/download/AM2018/Flipbook/mobile/index.html#p=1). You can also follow us live during EASD 2018 on Twitter (https://twitter.com/AstraZeneca) and LinkedIn (https://www.linkedin.com/company/astrazeneca/).

- ENDS -

NOTES TO EDITORS

About AstraZeneca in Cardiovascular, Renal & Metabolism (CVRM)

Cardiovascular, renal and metabolism together form one of AstraZeneca's main therapy areas and are key growth drivers for the Company. By following the science to understand more clearly the underlying links between the heart, kidneys 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 potentially 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. 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.

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