CSL hit by late-stage study failure for heart drug

12 Feb 2024
firstwordpharma.com
Phase 3AHA
CSL said Monday that a Phase III study of CSL112 in reducing the risk of major adverse cardiovascular events (MACE) in patients following an acute myocardial infarction failed to meet its primary endpoint, wiping nearly 5% off the company’s share price.
The AEGIS-II trial investigated the cholesterol efflux enhancer for the reduction of recurrent cardiovascular events in the 90-day high-risk period that follows a heart attack. The study, which was unveiled in 2017, included over 18,200 patients who were given four weekly doses of CSL112 or placebo initiated within five days of first medical contact.
CSL noted that the study missed its primary efficacy endpoint of MACE reduction at 90 days, while there were no major safety or tolerability concerns with CSL112. Further analysis of AEGIS-II is ongoing and primary results will be presented at the American College of Cardiology (ACC) scientific sessions in April.
Future uncertain
"Substantial work remains to fully analyse and understand the complete data and then to determine any development path ahead for this asset,” remarked Bill Mezzanotte, CSL’s head of R&D. The therapy is a formulation of plasma-derived apolipoprotein A-I reconstituted to form HDL particles suitable for intravenous infusion.
However, UBS analyst Laura Sutcliffe said she would be surprised to see any further development of CSL112 in a wide population. “If there is a compelling subgroup, perhaps further development with smaller or shorter studies is an option, but this is rarely the outcome at this stage,” Sutcliffe added.
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