The Digibind efficacy evaluation in pre-eclampsia (DEEP) study is a placebo-controlled investigation of the efficacy and safety of GlaxoSmithKline’s Digibind in 50 patients with severe pre-eclampsia. The study enrolled women experiencing severe pre-eclampsia in the 24th – 34th week of pregnancy, and for whom the delivery of the baby was considered necessary within 72 hours to prevent possible life-threatening complications for the mother and baby.
Primary endpoints are the use of antihypertensive medication and creatinine clearance which is a clinically important measure of renal function. Secondary endpoints include the time to delivery of the baby. The study is on track to report in the first half of 2008.
Following the licensing deal with Glenveigh Pharmaceuticals announced in December 2006, Protherics has the rights to use Digoxin Immune Fabs (DigiFab and Digibind) as potential treatments for pre-eclampsia. If the data from the DEEP study are positive, the company will decide whether to continue development in this indication with Digibind or its own product, DigiFab.
Andrew Heath, CEO of Protherics, said: “We are delighted that the last patient has been enrolled ahead of schedule and we look forward to seeing the results in the first half of 2008. If the data are positive, we will talk to the regulators to determine the next steps in bringing this potential new treatment for severe pre-eclampsia to the market to improve prospects for both mother and baby.”