Delays in recruiting patients into a pivotal trial of Speedel’s candidate diabetic kidney disease treatment SPP301 will delay the completion of the study for three to six months, according to the company.
The primary reason for the delay has been difficulties in patient recruitment in the Phase III trial, said Speedel. Earlier the company had estimated that it would be three-quarters enrolled by the end of 2006, but still only has a little over half the target number enrolled.
Speedel said it had taken steps to increase the sign-up rate, including a hike in the number of clinical centres and countries participating in the study, and still aims to have 2,000 enrolled by the middle of 2007, with results available by the end of 2009.
The Swiss company made the announcement in its third-quarter results statement, in which it said that its forecast cash burn for 2006 has been reduced to 70-75 million Swiss francs ($56m-$60m) from 80 million francs because of the delay in recruiting into the trial.
As of September 30, the company ha cash and liquid assets of 145 million francs, enough to fund R&D through the first quarter of 2008, according to chief financial officer Konrad Wirz.