Wave Life Sciences crashes on decision to drop neurology asset on trial setback
Baris-Ozer
Wave Life Sciences (NASDAQ:WVE) announced Tuesday it decided to halt further development of its neurology candidate WVE-004 after a failure in a Phase 1/2 trial for certain patients with amyotrophic lateral sclerosis (ALS) and dementia. WVE shares fell ~27% in the pre-market after the announcement.
Citing topline data from its Phase 1b/2a FOCUS-C9 study, the Singapore-based company said that there was no clinical benefit from WVE-004 compared to placebo in patients with C9orf72-associated ALS and frontotemporal dementia (FTD) (C9-ALS/FTD).
As part of the global study, subjects received multiple 10 mg doses of WVE-004 or placebo every 12 weeks or every four weeks, and there was an additional cohort receiving 20 mg single doses.
After a 24-week follow-up, WVE-004 was found to have no clinical benefit, but there was a reduction of Poly(GP), a pharmacodynamic biomarker indicating the effects of WVE-004 on a compound believed to cause C9-ALS/FTD.
However, the company said there was no relationship between the decline in Poly(GP) and stabilization or improvement in functional outcomes.
“Based on these data, and in the absence of biomarkers reasonably likely to predict clinical outcomes, Wave has decided to discontinue development of WVE-004,” Wave (WVE) added.