Arrowhead Pharma Doses First Patients in PALISADE Phase 3 Study of ARO-APOC3 in Adults with Familial Chylomicronemia Syndrome

Arrowhead Pharma Doses First Patients in PALISADE Phase 3 Study of ARO-APOC3 in Adults with Familial Chylomicronemia Syndrome

Arrowhead Pharmaceuticals announced the first patients have been dosed in PALISADE, a Phase 3 clinical study to evaluate the efficacy and safety of ARO-APOC3 in adults with familial chylomicronemia syndrome (FCS). ARO-APOC3 is an investigational RNA interference (RNAi) therapeutic designed to inhibit the production of apolipoprotein C3 (APOC3), a key regulator of triglyceride metabolism. The primary objective of the study is to evaluate the change from baseline in triglycerides between each ARO-APOC3 dose and pooled placebo at month 10.

Arrowhead presented data from a phase 1/2 trial in December at the American Heart Association (AHA) Scientific Sessions. In four patients with genetically confirmed FCS, ARO-APOC3 treatment led to a maximal mean reduction in APOC3 of up to 98%, a maximal median decrease in triglycerides of up to 91% and was generally well-tolerated. These changes are similar to those observed in 26 patients that had severe hypertriglyceridemia and similar baseline triglyceride levels but did not carry biallelic mutations consistent with FCS.

The global, placebo-controlled PALISADE study will evaluate the efficacy and safety of ARO-APOC3 in approximately 60 ad...

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