Ionis' olezarsen meets Phase III endpoint in FCS

USA-based Ionis Pharmaceuticals (Nasdaq: IONS) yesterday released positive top-line results for the Phase III Balance study of olezarsen in people with familial chylomicronemia syndrome (FCS), a rare genetic disorder.

Shares of the California-based drug developer rose 8.7% to $45.95. If approved, olezarsen will be the first available treatment for FCS in the USA, Ionis said.

The trial met its primary efficacy endpoint with a statistically significant reduction in triglyceride (TG) levels with the olezarsen 80mg monthly dose at six months compared to placebo (p=0.0009); triglyceride lowering continued to improve at 12 months. In addition, olezarsen 80mg showed a 100% reduction in acute pancreatitis events compared to placebo (0 events for olezarsen versus 11 events for placebo), a key secondary endpoint.