The pivotal trial is a placebo-controlled morbidity and mortality study with over 2,000 patients, designed to assess time to doubling of serum creatinine, end-stage renal disease or death in type 2 diabetes patients with overt diabetic nephropathy (diabetic kidney disease).
The study will be conducted in about 260 clinical sites in Europe, the US and other countries. It is estimated that the investigation will last approximately 3.5 years.
In view of the high unmet medical need diabetic nephropathy represents, Speedel’s diabetic treatment SPP301, originally licensed from Roche in 2000, has been granted fast track designation and has undergone a special protocol assessment by the FDA. This means that the review process is expedited and that assuming successful registration, SPP301 could be launched in the US in late 2009 and in other countries in 2010.
Dr Alice Huxley, CEO of Speedel, said: “This milestone is of major strategic importance for Speedel as SPP301 is the first drug which we have progressed into phase III ourselves and it is a considerable commercial opportunity.”