Alexion's Soliris fares well in Ph III PNH trial

The USA's Alexion Pharmaceuticals says that positive preliminary six-month interim results from SHEPHERD, its second Phase III trial testing Soliris (eculizumab) in a broader population of Paroxysmal Nocturnal Hemoglobinuria patients, were presented at the 66th annual scientific sessions of the American Diabetes Association, held in Washington DC.

The SHEPHERD trial is an open-label, non-placebo controlled, 12-month Phase III study which is primarily focused on examining safety, as well as efficacy measures and Alexion noted that interim results show that Soliris (eculizumab) is "safe and well-tolerated." All prespecified primary and secondary efficacy endpoints were achieved with statistical significance. The primary surrogate of efficacy endpoint, intravascular hemolysis, as measured by lactate dehydrogenase area under the curve, was significantly decreased (p<0.00000000001). LDH was reduced 87% from a median of 2,051 at baseline to 270 U/L after 26 weeks.