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Alnylam Hopes To Resume Fitusiran Dosing Quickly, Despite Unclear Cause Of Trial Death

 
• By Joseph Haas

The RNAi pioneer voluntarily suspended dosing of the hemophilia candidate to consider trial protocol alterations after a patient receiving fitusiran in an open-label, Phase II trial died following a thrombosis event.

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Less than a year after shuttering its amyloidosis candidate revusiran due to patient deaths in a Phase III trial, Alnylam Pharmaceuticals Inc. announced another setback Sept. 7, saying it was temporarily suspending dosing in ongoing studies of its hemophilia candidate fitusiran because of a patient death in a Phase II trial.

Alnylam said it hopes to restart dosing of fitusiran within three to six months by amending safety protocols in ongoing studies, including the just initiated Phase III trial ATLAS

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