CSL (CSL.AX, CSLLY) recently revealed disappointing results from their third phase of the AEGIS-II trial. This trial sought to assess the effectiveness and safety of CSL112 (apolipoprotein A-I [human]) in reducing repeated cardiovascular incidents during the high-risk 90-day time frame following a heart attack. Sad to note, the study failed to achieve its primary effectiveness endpoint of reducing major adverse cardiovascular attacks at 90 days.
Given these results, no immediate plans are being made for a regulatory filing. The company did, however, affirm that there were no significant safety or tolerance issues associated with CSL112.
The third phase of the AEGIS-II study saw over 18,200 patients participating. Originating from over 850 locations in 49 countries, they were randomized to receive either 4 weekly doses of CSL112 or a placebo within the first 5 days of their initial medical encounter.
CSL112, or Apolipoprotein A-I (Human), is an experimental cholesterol efflux enhancer. It is developed using a distinctive formulation of human plasma-derived apoA-I, which is a primary functional element of high-density lipoproteins, or HDL.
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