Alexion says early results of phase 3 Soliris trial meet primary, secondary endpoints

By Elaine Rigoli

Tampa, Fla., June 12 - Alexion Pharmaceuticals, Inc. reported positive preliminary six-month interim results from Shepherd, its second phase 3 trial testing Soliris (eculizumab) in a broader population of paroxysmal nocturnal hemoglobinuria (PNH) patients.

All pre-specified primary and secondary efficacy endpoints in the international trial were achieved with statistical significance, according to a news release.

Shepherd is an open-label, non-placebo controlled 12-month phase 3 PNH study, which is primarily focused on examining safety as well as efficacy measures. Interim results show that Soliris appeared to be safe and well-tolerated.

PNH, a rare form of hemolytic anemia, is an acquired genetic blood disorder characterized by destruction of red blood cells by the body's complement system, a component of the immune system.

Alexion Pharmaceuticals, located in Chesire, Conn., is a biotechnology company that develops drug therapies for patients with serious and life-threatening medical conditions.

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