Ionis announces positive olezarsen topline results from Phase 3 study in people with familial chylomicronemia syndrome

Olezarsen met the primary endpoint with a statistically significant reduction in triglyceride levels versus placebo First study to show an absolute reduction in acute pancreatitis in FCS patients, with olezarsen 80 mg monthly dose reducing events by 100 percent Olezarsen demonstrated a favorable safety and tolerability profile Ionis plans to file a New Drug Application with U.S. FDA in preparation for first potential independent launch Phase 3 studies continue evaluating olezarsen in broader patient population with severe hypertriglyceridemia (SHTG) Ionis to host webcast today at 11 a.m. ET CARLSBAD, Calif., Sept. 26, 2023 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced positive topline results for the Phase 3 Balance study of olezarsen in people with familial chylomicronemia syndrome (FCS). The trial met its primary efficacy endpoint with a statistically significant reduction in triglyceride (TG) levels with the olezarsen 80 mg monthly dose at six months compared to placebo (p=0.0009); triglyceride lowering continued to improve at 12 months. In addition, olezarsen 80 mg showed a 100 percent reduction in acute pancreatitis events compared to placebo (0 events for olezarsen versus 11 events for placebo), a key secondary endpoint.

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