AstraZeneca has started a clinical trial programme to try to extend the use of its diabetes drug Forxiga into kidney disease and heart failure.
The pharma company has two phase IIb outcome trials planned – one involving patients with chronic kidney disease (CKD) and the other in chronic heart failure – and is recruiting patients with and without type 2 diabetes for them.
The company is also starting new mechanistic trials designed to understand “the underlying science behind the potential cardiovascular and renal protective signals seen with the SGLT-2 inhibitor class”.
SGLT2 inhibitor Forxiga (dapagliflozin) is one of AZ’s fastest-growing products, with sales rising nearly 90% to $376m in the first half of the year.
It is however facing intense competition from Boehringer Ingelheim and Eli Lilly’s rival SGLT2 inhibitor Jardiance (empagliflozin), which is riding high after becoming the first type 2 diabetes drug shown in a clinical trial to reduce the risk of cardiovascular death.
While the CHF outcomes study is an attempt to catch up with Jardiance, AZ says the CKD study is the first “major outcome trial” looking for a benefit for an SGLT2 inhibitor in both diabetic and non-diabetic patients.
Boehringer and Lilly have already reported a benefit in CKD from their Jardiance outcomes trial, which included type 2 diabetes patients with established cardiovascular disease.
If successful, the trial could give the company a competitive lift in the marketplace. Kidney disease (nephropathy) is a well-recognised complication that affects some patients with diabetes, Diabetes is the most common cause of kidney failure, and around one in five people needing dialysis have diabetic kidney disease.
If AZ can also show an impact in non-diabetic kidney disease it could however open a up a much larger market. The European Renal Association (ERA) estimates that 10% of the population CKD, and about 70m Europeans have lost some of their kidney function and are at high risk of becoming dependent on renal replacement therapies such as dialysis or transplantation.
AZ estimates there are currently 200 million people worldwide currently living with CKD, and another 38 million living with CHF.