India, Feb. 11 -- CSL (CSL.AX, CSLLY) announced a negative result from the Phase 3 AEGIS-II trial, which evaluated the efficacy and safety of CSL112 (apolipoprotein A-I [human]) in the reduction of recurrent cardiovascular events in the 90-day high-risk period that follows a heart attack. The study did not meet its primary efficacy endpoint of major adverse cardiovascular events reduction at 90 days.
As a result, there are no plans for a near-term regulatory filing. There were no major safety or tolerability concerns with CSL112, the company said in a statement.
The Phase 3 AEGIS-II study enrolled over 18,200 patients from over 850 sites in 49 countries. Participants were randomized to receive 4 weekly doses of CSL112 or placebo initiated...