Roche to discontinue Phase 3 dosing in Huntington's disease trial

 Roche (SIX: RO, ROG; OTCQX: RHHBY) today

announced the decision to discontinue dosing in the Phase III GENERATION 
HD1 study of tominersen in manifest Huntington's disease (HD). The 
decision was based on the results of a pre-planned review of the data 
from the Phase III study conducted by an unblinded Independent Data 
Monitoring Committee (iDMC). The iDMC made its recommendation based on 
the investigational therapy's potential benefit/risk profile for study 
participants. No new or emerging safety signals were identified for 
tominersen in the review of the data from this study. Roche intends to 
continue following participants for safety and clinical outcomes, 
without the dosing of the investigational medicine or placebo. Once full 
data from the Phase III study are available and analysed, Roche will 
share learnings and future plans with the HD community. 
 
 
 
   Dosing will be paused in the open-label extension study (GEN-EXTEND) of 
tominersen while data are carefully analysed to inform next steps on 
this study. 
 
 
 
   "This is very unfortunate news to deliver on the tominersen Phase III 
study and we know it will be especially difficult for people with 
Huntington's disease to hear. The HD community currently has no 
treatments to stop or slow the progression of this rare 
neurodegenerative disease that impacts families across generations." 
said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head 
of Global Product Development. "GENERATION HD1 is the largest clinical 
trial in Huntington's disease to date and we do know that the data 
generated will significantly advance our understanding of 
huntingtin-lowering as a potential treatment approach. We would like to 
thank all of the individuals and families participating in the study for 
their contribution, as well as the broader HD community for their 
commitment and collaboration." 
 
 
 
   The Phase I PK/PD study (GEN-PEAK) of tominersen and the observational 
Roche HD Natural History Study will continue. 

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