Alnylam Ends Revusiran In Phase III, But Was Failure Due To Safety Or Efficacy?
Alnylam’s stock fell more than 40% in after-hours trading following the decision to end development of revusiran based on an imbalance of deaths in the Phase III ENDEAVOR clinical trial, but executives see no read-through to the rest of the company’s RNAi platform.
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Clinical trial failures and holds for drugs derived from nucleic acids from Alnylam and Ionis join those of Dicerna and Genta as the hit rate for these drugs continues to degrade. The real question is whether the failures have been due to a lack of efficacy or safety.
Despite its stock price falling 48% 24 hours after the shuttering of lead candidate revusiran, Alnylam is encouraged by analyst reports indicating the failure does not read through to its overall pipeline. The biotech reaffirmed its timeline for its second Phase III candidate patisiran.
Fitusiran's mechanism of reducing antithrombin levels could apply to all hemophilia patients, as well as those with other rare bleeding disorders. Reducing antithrombin increases thrombin levels and helps to increase normal clotting.