Genentech: Dosing to Stop in Phase III Clinical Study of Tominersen

   By Stephen Nakrosis 
 

Genentech on Monday said it would discontinue dosing in a Phase III study of tominersen in manifest Huntington's disease.

The company said it would cease dosing in its Phase III GENERATION HD1 clinical study of tominersen following a recommendation from an Independent Data Monitoring Committee.

"The iDMC made its recommendation based on the investigational therapy's potential benefit/risk profile for study participants," Genentech said, adding, "no new or emerging safety signals were identified for tominersen in the review of the data from this study."

The company also said it would continue to follow study participants for safety and clinical outcomes.

"Once full data from the Phase III study are available and analyzed, Genentech will share learnings and future plans with the HD community," it said.

"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," Genentech said.

The company also said its "Phase I PK/PD study (GEN-PEAK) of tominersen and the observational Genentech and Roche HD Natural History Study will continue."

Genentech is a member of the Roche Group.

--Write to Stephen Nakrosis at [e-mail]

(END) Dow Jones Newswires

March 22, 2021 16:43 ET (20:43 GMT)

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