Global biotherapeutics leader CSL Behring, located in King of Prussia, announced that it will proceed with a global Phase 3 cardiovascular morbidity and mortality trial for CSL112, the company’s novel apolipoprotein A-I (apoA-I) infusion therapy.
The study, ApoA-I Event reducinG in Ischemic Syndromes II (AEGIS-II), will enroll more than 17,000 patients from approximately 1,000 sites around the world to evaluate whether CSL112 reduces cardiovascular events in high-risk patients during the critical 90 days after a heart attack. The decision was announced during CSL’s annual R&D Investor Briefing, writes markets.businessinsider.com
Cardiovascular disease (CVD) is the leading cause of death globally. Every year in the US, an estimated 800,000 people will suffer an acute myocardial infarction (MI), or heart attack, and nearly one in five survivors will experience a recurrent cardiovascular event (non-fatal MI, stroke, cardiovascular death) within one year. The majority of these recurrent events happen within the first 90 days and are associated with a high rate of morbidity and mortality. In addition, recurrent events are associated with increased economic and healthcare burden.
“Despite recent advances in cardiovascular care, we still have an unacceptable rate of early recurrent cardiovascular events occurring in high-risk patients following an acute MI,” said C. Michael Gibson, M.D., Ph.D., Professor of Medicine at Harvard Medical School and co-lead investigator of the AEGIS-II study. “We are optimistic that CSL112 will offer a novel, rapid approach to reduce these events during the 90-day period when heart attack survivors are most vulnerable.”
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