drugset / Press release

Ionis' partner provides update on clinical studies evaluating tominersen (IONIS-HTT Rx)

2021-03-22 · Ionis Pharmaceuticals · original ionis.com ↗

- Dosing to stop in Phase III clinical study of tominersen and paused in the open-label extension study (GEN-EXTEND) - The Phase I PK/PD study (GEN-PEAK) of tominersen and the observational Roche HD Natural History Study will continue - No new or emerging safety signals for tominersen were identified - Ionis to host webcast today, March 22, 2021, at 5 p.m. ET CARLSBAD, Calif., March 22, 2021 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) announced its partner, Roche, has decided 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 data from the Phase III study conducted by an unblinded Independent Data Monitoring Committee (iDMC). 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.

The release as fetched from its publisher. ionis.com ↗