Silence Therapeutics has completed enrolment of patients in the ALPACAR-360 Phase II trial of zerlasiran (SLN360) to treat patients with elevated lipoprotein(a) (Lp(a)) and are at high risk of atherosclerotic cardiovascular disease (ASCVD) events.
The study is designed to evaluate nearly 160 subjects with high Lp(a) ≥ 125 nmol/L at high risk of ASCVD events.
Time averaged change in Lp(a) from baseline is the primary endpoint of the study.
Silence Therapeutics president and CEO Craig Tooman said: “The fact that it took less than four months to enrol this trial really speaks to the incredible market opportunity, growing awareness of Lp(a) as a key cardiovascular risk factor and strong execution by our team.
“We are now tracking well ahead of our original timelines and currently anticipate reporting topline data in mid-2024.
“There’s a great deal of interest and excitement around this programme, and we look forward to providing further updates at the appropriate time.”
Median maximal Lp(a) reductions of 96% and 98% were also observed in patients with high Lp(a) ≥ 150 nmol/L who received zerlasiran 300mg and 600mg doses, respectively in Phase I APOLLO single dose study of Silence.
During 150 days of follow up, median time-averaged reductions exceeded 80% in 300mg and 600mg treatment groups of zerlasiran. It was also well tolerated with no serious safety issues.
Topline data from the multiple dose portion of the company’s APOLLO programme are expected in the fourth quarter of this year.