COMPASS points Ionis toward hypertriglyceridemia submissions

Ionis Pharmaceuticals Inc. (NASDAQ:IONS) said volanesorsen (IONIS-APOCIIIRx) met the primary endpoint in the Phase III COMPASS trial in patients with severe hypertriglyceridemia. Next year, the company plans to submit regulatory applications for the candidate in the U.S., Europe and Canada.

In the 113-patient study, volanesorsen reduced mean triglycerides from baseline after 13 weeks by 71.2% vs. 0.9% for placebo (p<0.0001). In a subset of seven patients with familial chylomicronemia syndrome (FCS), volanesorsen reduced mean triglycerides by 73% vs. a mean increase of 70% for placebo. Among all patients, 82% of those receiving volanesorsen, including three from the FCS subset, achieved triglyceride levels below 500 mg/dL vs. 14% for placebo (p<0.0001) after 13 weeks...