The decision was taken following a significant imbalance in fluid retention in patients in the study. Speedel commented that fluid retention is not unusual in patients who have severe diabetic kidney disease. However, given the fragility of these patients, the company said it was being prudent in not continuing to expose them to any further complications in this study.
The company still believes that SPP301 has potential and the compound will be continued to be tested. Speedel will explore possible alternative trial designs for SPP301 and for potential new indications. An announcement concerning the next steps for SPP301 should occur around the middle of 2007.
“We are highly committed to carrying out a thorough analysis of the data from the trial to devise the best possible way to continue development of SPP301. There is a need to generate an optimum study design for potential new clinical trials with this compound,” stated Giancarlo Viberti, Chairman, professor of diabetes and metabolic medicine at Guy’s Hospital London.
Speedel has exclusive worldwide development and commercialization rights to SPP301 under a licensing agreement with Roche.