- Wave Life Sciences Ltd WVE announced an update to the ongoing Phase 1b/2a SELECT-HD trial of WVE-003 for Huntington’s disease (HD).
- Eighteen (18) participants have been dosed in the SELECT-HD trial.
- Single doses of WVE-003 up to 90 mg appeared generally safe and well-tolerated.
- Among participants in the 30 and 60 mg WVE-003 cohorts, the mean reduction in CSF mHTT from baseline was 22% (median reduction of 30%) at 85 days following a single dose.
- Related: Ahead Of Upcoming Data On Three Programs, Analysts Remain On Sidelines For Wave Life Sciences.
- In the 30 and 60 mg cohorts, wtHTT protein was preserved, which appears consistent with allele-selectivity.
- Increases in neurofilament light chain (NfL) from baseline were observed in some participants. Wave will continue to monitor trends in NfL as SELECT-HD advances.
- There were no clinically meaningful elevations in CSF white blood cell counts or protein indicating inflammation in the CNS.
- There were no meaningful changes in clinical outcome measures, although the dataset and duration were insufficient to assess clinical effects.
- Based on these data, Wave is adapting the SELECT-HD trial to expand the single-dose cohorts and will also continue advancing the 90 mg cohort for biomarker analysis at day 85.
- Additional single dose biomarker and safety data are expected in the first half of 2023.
- Price Action: WVE shares are up 1.47% at $3.44 on the last check Tuesday.