Arrowhead to advance plozasiran into Phase 3 cardiovascular outcomes trial

Arrowhead Pharmaceuticals announced plans to advance investigational plozasiran into a Phase 3 cardiovascular outcomes trial called CAPITAN. “This comes after promising results were recently announced from multiple clinical trials in three distinct patient populations, including the pivotal Phase 3 PALISADE study in patients with genetically confirmed or clinically diagnosed familial chylomicronemia syndrome, or FCS, the Phase 2 SHASTA-2 study in patients with severe hypertriglyceridemia, or SHTG, which was published in JAMA Cardiology, and the Phase 2 MUIR study in patients with mixed hyperlipidemia, which was published in the New England Journal of Medicine,” the company stated. “We recently announced successful topline results from the Phase 3 PALISADE study, which evaluated plozasiran in patients with FCS. The study met the primary endpoint of lowering triglycerides and met all key secondary endpoints, including reducing the incidence of acute pancreatitis, compared to placebo. Today, we are adding more context to those results and will show that plozasiran, administered once every three months, consistently maintained the median and mean triglyceride levels over the study period with low variability. These are exciting results, and we are eager to share more of these data at upcoming medical congresses. We see plozasiran clinical data as strong and consistent across multiple studies in patients with FCS, SHTG, and mixed hyperlipidemia, and believe plozasiran has the potential to address significant unmet needs in all three patient populations. Based on this we are allocating substantial resources to the Phase 3 SHASTA studies in patients with SHTG and the newly announced Phase 3 CAPITAN study in patients with mixed hyperlipidemia and residual risk of ASCVD. Our second cardiometabolic program, zodasiran, achieved highly encouraging results, including decreases in triglyceride levels and robust and durable reductions in triglyceride-rich lipoproteins, remnants, and total atherogenic lipoproteins, which we believe supports further investigation in Phase 3 studies. However, based on our various assessments for both candidates, and resource allocation considerations, we have elected to broadly advance plozasiran ourselves and, at this time, will only conduct further development of zodasiran if we identify a suitable development and commercialization partner,” said Bruce Given, M.D., chief medical scientist at Arrowhead.