Leaders at Pfizer Inc. recently announced that it has finished its patient enrollment process for its worldwide SPIRE-2 cardiovascular outcome trial to evaluate the company’s investigational agency, bococizumab.
The program aims to assess PCSK9 inhibitors and how efficient they are in decrease the chances of cardiovascular events in patients who qualify as high-risk. Patients do not quality if they have a history of cardiovascular events.
The study will determine whether bococizumab is safe and effective at decreasing the chance of major cardiovascular events compared to a placebo. The study involves 10,600 patients who qualify as high-risk for cardiovascular disease. All of them currently take highly effective statins or have a document statin intolerance.
“Pfizer has been a leader in redefining the management of cardiovascular risk for decades, and we are applying our deep understanding of cardiovascular disease to the SPIRE Phase 3 program,” James Rusnak, therapeutic area clinical head for cardiovascular and metabolic disease, Global Product Development, said. “We have designed our cardiovascular outcome trials differently from other PCSK9i outcome trials to include both primary and secondary prevention patients at high risk for a cardiovascular event.”
The study is the first in a two-part series of cardiovascular outcome trials. Both of them are part of the SPIRE Phase 3 worldwide clinical development program, designed to assess the Proprotein Convertase Subitilisin Kexin type 9 inhibitor (PCSK9i).
