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

 ­ Ref: Roche | Image: Roche