Speedel stops diabetic nephropathy study

Switzerland-based biopharmaceutical firm Speedel says that it has stopped the current Phase III trial of SPP301 (avosentan), its developmental therapy for diabetic nephropathy, in the interests of patient safety. The firm explained that it had taken the step following the observation of a significantly higher level of fluid retention in those treated with the drug, in comparison with patients on placebo.

Speedel's medical director, Jessica Mann, said that, although fluid retention is not unusual in patients who have severe diabetic kidney disease, the company thought it prudent not to expose this fragile patient group to any additional risk. The firm said that it will inform health authorities, including the US Food and Drug Administration, and is in the process of notifying all trial investigators.

Lehman Brothers said that, while it does not regard SPP301 as a near-term value driver for the Swiss firm, the agent was the basis for 30%, or 86 Swiss francs per share, of its valuation, and that therefore, failure does remove a significant proportion of long-term potential earnings.