Arrowhead Pharmaceuticals Completes Enrollment of Phase 3 PALISADE Clinical Trial Evaluating ARO-APOC3 for Treatment of Familial Chylomicronemia Syndrome

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[{"type":"text","content":"\n- Primary Study Completion Anticipated in the Second Quarter of 2024\n\n\n PASADENA, Calif.--(BUSINESS WIRE)--\nArrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced that it has completed enrollment of its global Phase 3 clinical trial (PALISADE) evaluating ARO-APOC3 for the treatment of familial chylomicronemia syndrome. The company anticipates that the primary portion of the study will be complete in the second quarter of 2024 with a data readout shortly thereafter and subsequent submissions for regulatory review and approval.\n\n\nJavier San Martin, M.D., chief medical officer at Arrowhead, said: “Completing enrollment of the Phase 3 PALISADE study represents a significant milestone for Arrowhead and brings our potentially important RNAi-based medicines closer to the patients that may benefit from them. I am grateful to the FCS patient community and principal investigators for their trust and participation in the PALISADE study.”\n\n\nAbout the Familial Chylomicronemia Syndrome\n\n\nFamilial chylomicronemia syndrome (FCS) is a severe and ultrarare genetic disease often caused by various monogenic mutations. FCS leads to extremely high triglyceride (TG) levels, typically over 900 mg/dL. Such severe elevations can lead to various serious signs and symptoms including acute and potentially fatal pancreatitis, chronic abdominal pain, type 2 diabetes mellitus, hepatic steatosis, and cognitive issues. Currently, the therapeutic options that can adequately treat FCS are very limited.\n\n\nAbout the PALISADE Phase 3 Study\n\n\nThe AROAPOC3-3001 PALISADE study (NCT05089084) is a Phase 3 placebo controlled study to evaluate the efficacy and safety of ARO-APOC3 in adults with FCS. The primary endpoint of the study is percent change from baseline in fasting TG at Month 10. A total of 75 subjects distributed across 39 different sites in 18 countries were randomized to receive 25 mg ARO-APOC3, 50 mg ARO-APOC3, or matching placebo once every three months. Participants who complete the randomized period are eligible to continue in a 2-part extension period, where all participants will receive ARO-APOC3.\n\n\nAbout ARO-APOC3\n\n\nARO-APOC3 is an investigational RNAi therapeutic being developed as a treatment for patients with mixed dyslipidemia, severe hypertriglyceridemia, and FCS. ARO-APOC3 is designed to reduce production of Apoli...

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