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IDMC recommends phase III GENERATION HD1 study of IONIS-HTTRx halted in Huntington's disease.- Ionis Pharma

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Published:24th Mar 2021
Ionis Pharmaceuticals announced its partner, Roche, has decided to discontinue dosing in the Phase III GENERATION HD1 study of IONIS-HTTRx (tominersen) in manifest Huntington's disease (HD). The decision was based on the results of a pre-planned review of data from the Phase III study conducted by an unblinded Independent Data Monitoring Committee (iDMC). While there were no new or emerging safety signals identified for tominersen, the iDMC made its recommendation based on the investigational therapy's potential benefit/risk profile for study participants. Participants will continue to be followed for safety and clinical outcomes.In addition, dosing will be paused in the open-label extension study (GEN-EXTEND) of tominersen while data are carefully analyzed to inform next steps on this study. Roche also stated that the Phase I PK/PD study (GEN-PEAK) of tominersen and Roche's observational HD Natural History Study will continue. Roche has stated that once full data from the studies are available and analyzed, Roche will share learnings and future plans with the community.
Condition: Huntington's Disease
Type: drug

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