GSK launch­es PhI­II lu­pus com­bo study with Benlysta/rit­ux­imab; Ci­pher snatch­es Cana­di­an drug port­fo­lio from Car­diome

→ GSK says it’s launch­ing a Phase III com­bo study to see how its lu­pus drug Benlysta (be­li­mum­ab) will work when com­bined with rit­ux­imab. The mon­o­clon­al an­ti­body rit­ux­imab has his­tor­i­cal­ly been used to treat can­cers like leukemia and lym­phomas, but al­so has been ef­fec­tive fight­ing rheuma­toid arthri­tis. GSK hopes com­bin­ing Benlysta (the on­ly bi­o­log­ic ap­proved to treat lu­pus) with rit­ux­imab will push lu­pus in­to re­mis­sion. “Be­li­mum­ab has al­ready demon­strat­ed its con­sis­tent ef­fi­ca­cy in re­duc­ing dis­ease ac­tiv­i­ty for pa­tients with SLE, with four suc­cess­ful Phase III tri­als,” Gi­js van den Brink, GSK’s glob­al head for im­muno-in­flam­ma­tion R&D, said in a state­ment. “The un­der­ly­ing bi­ol­o­gy of the dis­ease, com­bined with the re­sults from a small in­ves­ti­ga­tor-spon­sored study in se­vere re­frac­to­ry SLE (lu­pus), pro­vide a strong sci­en­tif­ic ra­tio­nale for ini­ti­at­ing this study. Our aim with this study is to as­sess whether the com­bi­na­tion treat­ment will not on­ly achieve a state of low dis­ease ac­tiv­i­ty, but po­ten­tial­ly al­so achieve clin­i­cal re­mis­sion in pa­tients liv­ing with this chron­ic and un­pre­dictable dis­ease.”

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