SPEEDEL HALTS TRIAL DUE TO SAFETY ISSUES

Speedel has, in the interests of patient safety, stopped its pivotal Phase III clinical trial of Avosentan (SPP301) in diabetic nephropathy. This decision was made by the ASCEND trial's steering committee based on a recommendation from the data safety monitoring board following a significant imbalance in fluid retention in patients. The company is informing health authorities, including FDA, and is in the process of notifying all clinical investigators in the trial.

The company also said that the compound will be evaluated for use in potential new clinical trials in diabetic kidney disease and other indications, and that an announcement concerning the next steps for SPP301 should occur midway through next year.

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. Speedel has exclusive worldwide development and commercialization rights to SPP301 under a licensing agreement with Roche.