AstraZeneca is presenting literally dozens of abstracts at this week’s American Society of Nephrology Kidney Week Annual Meeting in San Diego. Not only does it represent ongoing research on already approved drugs, but promising pipeline products. Danilo Verge, vice president of CVRM Medical Affairs at AstraZeneca took time to talk to BioSpace about the presentations and how they reflect the company’s ongoing strategy in cardiovascular, renal and metabolic diseases.
“In general,” Verge says, “the acronym I described (CVRM) really tells us the story of where AstraZeneca is focusing its efforts. It’s the intersection between cardiovascular, renal and metabolism. We’re now to the point where it’s fairly clear that patients suffering from one of these conditions will, given enough time, develop symptoms around all three conditions.”
In other words, a diabetic patient will often develop cardiovascular disease and potentially renal disease. Someone with cardiovascular disease often has metabolic problems and could develop renal disease as a result.
The presentations at ASN largely focus on three compounds as well: Farxiga (dapagliflozin), Lokelma (sodium zirconium cyclosilicate) and roxadustat.
Farxiga is an SGLT2 inhibitor, a relatively new class of drugs to treat type 2 diabetes, and it’s been approved for that indication. But AstraZeneca is evaluating the drug in related indications. Verge told BioSpace, “What we are presenting at ASN, a poster and an oral presentation, is that we looked at the effect of Farxiga in the urinary complications of type 2 diabetes. We’re looking at what the drug can do when added to insulin in type 1 diabetes, that’s one aspect. The other is an oral presentation regarding a reduction in urea in type 1 diabetes.”
Lokelma was approved in May 2018 by the Food and Drug Administration (FDA) for adults with hyperkalemia, or high potassium blood levels. This is associated with cardiovascular, renal and metabolic diseases.
Verge said the company was presenting 11 abstracts related to Lokelma. One describes the results from the HARMONIZE Global study, which examines Lokelma for hyperkalemia. HARMONIZE looked at 267 patients with hyperkalemia in 47 locations in the Asia Pacific region. AstraZeneca presented the data on October 25, showing that normal potassium levels were maintained, regardless of dosage, in patients receiving Lokelma.
“The positive results of HARMONIZE Global add to the growing body of evidence supporting the use of Lokelma for adults with hyperkalemia, a serious condition associated with chronic kidney disease, heart failure and diabetes, as well as the use of renin-angiotensin-aldosterone system inhibitors,” stated Elisabeth Bjork, vice president, Head of Cardiovascular, Renal and Metabolism, Global Medicines Development, for AstraZeneca.
“Then we’re also looking at a shorter study of the correction of potassium with Lokelma patients in Japan with hyperkalemia. We’re also looking—perhaps the most interesting application of these compounds—at the use of Lokelma in patients with diabetes.”
And finally, roxadustat is a hypoxia-inducible factor (HIF) prolyl-hydroxylase inhibitor being developed for anemia in chronic kidney disease. The compound is being studied in six Phase III trials jointly by AstraZeneca, FibroGen and Astellas. AstraZeneca is presenting nine posters and one oral presentation about roxadustat at ASN.
“Primarily what we’re doing is providing the epidemiological data for the unmet need and showing how big the problem of anemia is in that patient population,” Verge said.
For example, one abstract, presented October 25, focuses on anemia treatment patterns in chronic kidney disease from three international physician surveys. Another presents the associations of hemoglobin levels and quality of life in patients with chronic kidney disease found in three international surveys.
In total, AstraZeneca is presenting 35 abstracts, posters or oral presentations at ASN.
Additional presentations include eight abstracts focusing on obesity, heart failure (HF) and renal disease and its collaboration with Ionis Pharmaceuticals. This focuses on antisense oligonucleotides (ASO) as a potential new approach and new targets for cardiovascular disease.
Verge told BioSpace, “We at AstraZeneca recognize that not only does the epidemiological data correlate with overlaps, but the underlying science does as well. So we are trying to ensure that as we develop new compounds within a specific area, we try to look at the impact each compound in development has, not only on the specific compound in each area, but what impact it has in the other areas that are not necessarily the ones they were developed for.”
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