Diabetic kidney disease drug hits safety obstacle
pharmafile | January 4, 2007 | News story | Research and Development, Sales and Marketing |Â Â Â
Swiss-based biotech company Speedel has axed its current phase III trial of SPP301 in diabetic kidney disease because of patient safety fears.
The decision was taken following the emergence of a significant imbalance in fluid retention in patients on the trial.
Dr Jessica Mann, Speedel's medical director, said: "This decision is based on data showing patients taking SPP301 developed higher levels of fluid retention than those on placebo."
She explained that although fluid retention was not unusual in patients with severe diabetic kidney disease, the company was "being prudent" in not exposing fragile patients to unnecessary risk.
Speedel will now carry out a thorough analysis of the trial data, with the intention of devising new clinical trial methods for the compound. The company said an announcement would be made about the future of SPP301 around the middle of 2007.
Dr Alice Huxley, Speedel's chief executive, said: "We are disappointed that this promising therapy could not complete the current phase III trial for diabetic kidney disease. We remain hopeful about its potential therapeutic benefits and we will now use the next six months to evaluate the study data and explore possible alternative trial designs for SPP301 in diabetic kidney diseases and its potential in other indications."
SPP301, a once-a-day oral endothelin-A receptor antagonist, showed in phase II trials that it decreases urinary albumin excretion rate and total cholesterol in patients with diabetic kidney disease when administered on top of standard treatment.
However, fears over its safety follow the pulling of AstraZeneca's late-stage diabetes drug Galida in the spring of 2006 after data showed the drug impaired kidney function.
Diabetic kidney disease represents a large and growing unmet need, affecting an estimated 7.9 million people diagnosed with diabetes in Europe, the US and Japan.
