Ionis Pharmaceuticals Partner Stops Dosing in Huntington's Disease Study
By Chris Wack
Ionis Pharmaceuticals Inc. said its partner, Roche Holding AG,
has decided to discontinue dosing in its Phase III study of
tominersen in manifest Huntington's disease.
The company said 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.
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.
Ionis said dosing also will be paused in the open-label
extension study of tominersen while data are carefully analyzed to
inform next steps on this study. Roche said the Phase I PK/PD study
of tominersen and Roche's observational HD Natural History Study
Roche has stated that once full data from the studies are
available and analyzed, it will share learnings and future plans
with the community.
Ionis shares were down 21% to $43.86 in premarket trading.
Write to Chris Wack at email@example.com
(END) Dow Jones Newswires
March 23, 2021 07:00 ET (11:00 GMT)
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