Drug for Diabetic Nephropathy in Phase 3 Trial

Speedel announced today the start of its Phase III study for SPP301, its once-a-day oral endothelin A receptor antagonist (ERA) in the indication of diabetic nephropathy (diabetic kidney disease). The ASCEND(1) study has begun with the first patient visit as per the schedule outlined by Speedel in March 2005 when the company reported successful completion of the Phase II clinical trials.

SPP301 is a once daily oral endothelin A receptor antagonist that Speedel licensed from Roche in October 2000 when it was in regulatory toxicology studies. SPP301, a second generation ERA, developed out of Roche’s endothelin research and drug discovery program, and was specifically optimised for improved liver safety. Speedel has taken the compound through a number of Phase I and exploratory Phase IIa clinical trials before selecting the novel indication of diabetic nephropathy for a Phase IIb clinical trial, the results of which were announced in March 2005.

Substantial evidence from animal testing and clinical studies suggest that endothelin plays a pivotal role in several diseases such as hypertension, chronic heart failure, and chronic nephropathies. Endothelin triggers renal vasoconstriction, decreases glomerular filtration rate and modulates sodium excretion and water balance at the level of the proximal tubule and medullary collecting ducts, by mechanisms that are still unclear.

In preclinical testing, chronic administration of Endothelin Receptor Antagonists protected animals, including those with induced diabetes, from developing renal injury.

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