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Ionis Antisense Platform Safety Questioned After Thrombocytopenia Seen In Studies

 
• By Joseph Haas

GSK halts plans for Phase III study of antisense candidate in FAC due to FDA clinical hold for findings of reduced platelet counts in another Phase III trial; Ionis reveals similar findings in Phase III study of another antisense compound.

Ionis Pharmaceuticals Inc. tried to put the most positive face on safety concerns with its entire second-generation antisense program during an investor call May 26, saying "less than a handful of patients" in an ongoing Phase III study had shown reduced platelet counts, but analysts came away citing at least the possibility of a class effect for second-generation antisense candidates generated by Ionis' platform.

GlaxoSmithKline PLC has not backed out of its partnership on the antisense candidate IONIS-TTRrx in Phase III for transthyretin-related (TTR) amyloid cardiomyopathy (FAC), yet, but Ionis announced May 26 that the big pharma partner is not initiating the planned Phase III CARDIO-TTR trial at the same time it revealed that lowered platelet

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