AUSTRALIA – Australian pharmaceutical company CSL has reported disappointing results from the Phase III AEGIS-II trial of CSL112, its post-heart attack drug, which failed to meet its primary endpoint of reducing the risk of major adverse cardiovascular events (MACE) at 90 days. 

 This setback has led to a more than 4.8% decline in CSL’s stock in trading today, with the company’s market capitalization standing at A$143.36 billion (US$93.4 billion). 

The AEGIS-II study, a placebo-controlled trial registered under NCT03473223, was one of the largest conducted by CSL, involving 18,200 patients with acute coronary syndrome, a precursor to heart attacks, across 185 sites worldwide.  

Participants received four weekly doses of CSL112 or placebo, beginning within five days of hospital admission. 

Although no major safety or tolerability concerns were noted in the treatment group, according to a press release dated February 11, CSL has indicated that it does not plan to seek regulatory approval for the drug in the near future.  

The company intends to share the trial results and present data at the American College of Cardiology Scientific Sessions in Atlanta from April 6 to 8. 

Following a heart attack, patients face a heightened risk of subsequent cardiac events, such as another heart attack. 

 A systematic review has shown that these patients have at least a 30% higher relative risk for all-cause death and cardiovascular outcomes compared to the general population. 

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CSL112, a human apolipoprotein A-I (apoA-I), was developed as an investigational cholesterol efflux enhancer. 

 Cholesterol efflux is the process by which high-density lipoproteins (HDL) transport cholesterol particles from plaques in the heart’s blood vessels to the liver for disposal. Enhanced cholesterol efflux is believed to reduce the likelihood of MACEs. 

In addition to CSL112, CSL’s pipeline includes Hemgenix (etranacogene dezaparvovec), a gene therapy for hemophilia B, which received FDA approval for adult treatment in 2022. 

 CSL also has a self-amplifying messenger ribonucleic acid (sa-mRNA) vaccine for Covid-19, ARCT-154, approved by Japan’s Ministry of Health, Labour and Welfare (MHLW) in November 2023 for preliminary vaccination and booster use in adults.  

ARCT-154 was developed through a global partnership and licensing agreement with Arcturus Therapeutics. 

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