The results show that SPP100, the first-in-class direct renin inhibitor, further lowers proteinuria in diabetic patients, independent of blood pressure, when administered on top of losartan, a standard therapy used to treat diabetic kidney disease.
For this multi-national, randomized, double-blind Phase III study 599 patients were enrolled. There was a three months open-label run-in period with patients receiving losartan 100mg once per day (OD) in addition to optimal antihypertensive therapy.
After these three months, patients were randomized to receive six-months treatment with placebo or aliskiren (150mg OD for three months followed by forced titration to 300mg OD for another three months) on top of losartan. The primary outcome was reduction in early morning urinary albumin creatinine ratio (UACR) from baseline to end of study.
SPP100 (aliskiren) provided a significant 20% reduction in mean UACR on top of standard therapy compared with placebo after 24 weeks (p= 0.0009, 95% CI: 9-30) and aliskiren also significantly reduced mean urinary albumin excretion rate (UAER) by 21% compared to placebo (p=0.009; 95% CI: 5-30). The number of patients with 50% reduction in UACR at the end of the study was 24.7% for aliskiren treated patients versus 12.5% for placebo (p = 0.0002).
Alice Huxley, CEO of Speedel, said: “We are encouraged by the potential of this novel class of therapy to provide patients with benefits over and beyond blood pressure lowering. High blood pressure is a co-morbidity found in 74% of diabetes patients and it is clear that new therapies are required to treat this vulnerable patient population. These study results highlight the possible long-term benefits of using renin inhibitors. Our next generation compounds are specifically designed to further enhance the effects on proteinuria, as we have demonstrated in our preclinical research.”