Indication finding

Neither of Alexion Pharmaceuticals Inc.'s two monoclonal antibodies against complement 5 have had an easy road. But the company finally seems to have discovered the right indication for one of them, reporting last week that Soliris eculizumab met all the primary and secondary endpoints in the Phase III TRIUMPH trial in paroxysmal nocturnal hemoglobinuria.

ALXN initially tested Soliris in idiopathic membranous nephritis, a disease characterized by a thickening of the kidney, causing protein to leak into urine. The thesis was that blocking C5 would reduce the inflammatory activity in the kidney that causes the glomeruli to leak blood proteins. However, an earlier Phase II trial in the indication missed the primary endpoint of proteinuria reduction after 4 months (see BioCentury, Nov. 11, 2002)...