Pro­to­cols: Did Io­n­is set out to ex­clude side ef­fects? Mer­ck takes an­oth­er step for­ward with Lan­tus biosim­i­lar

Biotech’s most feared re­porter, Adam Feuer­stein, has not been a big fan of Io­n­is. And it’s un­like­ly that there’s much love lost these days at the an­ti­sense RNA com­pa­ny. This morn­ing, Feuer­stein pub­lished a slide that the com­pa­ny mis­tak­en­ly in­clud­ed in a batch sent out to an­a­lysts, which in­clud­ed a few key strate­gic moves it made in the wake of its trou­bles with Ky­nam­ro. The list be­gins: “Re­duce fo­cus on elic­it­ing side ef­fect re­ports in Phase 2/3.” And it goes on to sug­gest not so­lic­it­ing re­ports on in­jec­tion site re­ac­tions and flu-like symp­toms, bet­ter “guid­ance” on that and few­er lab chemistries. “One trou­bling in­ter­pre­ta­tion of this slide sug­gests Io­n­is, learn­ing from the painful Kyanam­ro ex­pe­ri­ence, in­tend­ed to un­der-re­port side ef­fects of its oth­er an­ti­sense drugs in mid- and late-stage clin­i­cal tri­als,” Feuer­stein re­ports. The com­pa­ny de­nies it in­tend­ed any such thing, but this is the kind of re­port­ing that can come back and haunt a biotech af­ter the next big set­back.

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