Shots:
- Roche discontinue the dosing in the P-III GENERATION HD1 study that assesses Tominersen (120 mg, every 2mos./120 mg every 4mos., IT) in 791 participants with manifest HD from 18 countries globally
- The discontinuation is based on the IDMC recommendation on potential benefit/risk profile for study participants that showed no new or emerging safety signals were identified for tominersen. Meanwhile, Roche plans to continue safety and clinical outcomes, without dosing of tominersen or PBO
- The company will also pause dosing in the GEN-EXTEND OLE study. Additionally, the P- I GEN-PEAK PK/PD study and the natural history study will continue for the same indication
Click here to read full press release/ article | Ref: Roche | Image: Stat News
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