Press release
Arrowhead Pharmaceuticals Reports Successful Topline Results for Plozasiran from the Pivotal Phase 3 PALISADE Study in Patients with Familial Chylomicronemia Syndrome
- Plozasiran achieved statistically significant median reductions in triglycerides up to 80% and mean reductions in APOC3 up to 94% at month 10 - Plozasiran
About this update from Arrowhead Pharmaceuticals, Inc.
[{"type":"text","content":"\n- Plozasiran achieved statistically significant median reductions in triglycerides up to 80% and mean reductions in APOC3 up to 94% at month 10\n\n\n- Plozasiran achieved a statistically significant reduction in incidence of acute pancreatitis versus placebo\n\n\n- Plozasiran is the company’s first investigational RNAi-based therapy to show clinical efficacy in a Phase 3 study\n\n\n- Arrowhead plans to highlight recent data for its cardiometabolic pipeline at its June 25, 2024, Cardiometabolic event as part of the 2024 Summer Series of R&D Webinars\n\n\n PASADENA, Calif.--(BUSINESS WIRE)--\nArrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced topline results from the pivotal Phase 3 PALISADE study of investigational plozasiran in patients with genetically confirmed or clinically diagnosed familial chylomicronemia syndrome (FCS), a severe genetic disease with significant unmet need and no FDA approved therapies. PALISADE successfully met the primary endpoint of lowering triglycerides and met all key secondary endpoints, including reducing the incidence of acute pancreatitis compared to placebo.\n\n\n“The strong results from the Phase 3 PALISADE study, evaluating plozasiran in patients with FCS, significantly build upon the promising results from the Phase 2 SHASTA-2 and MUIR studies in patients with severe hypertriglyceridemia and mixed hyperlipidemia, recently published in JAMA Cardiology and the New England Journal of Medicine. These findings highlight the potential of plozasiran as a promising therapy for patients with various cardiometabolic disorders,” said Bruce Given, M.D., chief medical scientist at Arrowhead. “We look forward to discussing results at our June 25th Cardiometabolic event as part of our 2024 Summer Series of R&D Webinars and presenting the full PALISADE data at upcoming medical conferences.”\n\n\nThe primary endpoint for the PALISADE study was placebo adjusted median change in triglycerides at Month 10. At that timepoint, patients treated with quarterly doses of 25 and 50 mg plozasiran achieved median triglyceride reductions of -80% and -78%, respectively, with a maximal reduction of -98%. At month 12, patients treated with 25 and 50 mg plozasiran achieved median triglyceride reductions of -78% and -73%, respectively, with a maximal reduction of -99%. These compared with median triglyceride redu...