Arrowhead Pharmaceuticals (ARWR) plozasiran met its primary and secondary endpoints in two phase 3 studies as a potential treatment for adults with severe hypertriglyceridemia, the company said Sunday.
Patients with severe hypertriglyceridemia have a significantly greater risk of developing acute pancreatitis, which can cause attacks that require hospitalization.
Plozasiran reduced triglycerides by 79% and 81% versus placebo in the two studies, and more than 90% of plozasiran-treated patients achieved triglycerides below thresholds for acute pancreatitis risk, the company said.
In a pooled analysis, plozasiran reduced acute pancreatitis events by 78% versus placebo, Arrowhead said, with the benefit more pronounced among higher-risk patients.
The drug also showed a favorable safety and tolerability profile in the two studies, the company said.
Arrowhead plans to file a supplemental new drug application for therapy with the US Food and Drug Administration by the end of the year, the company said.