Silence Therapeutics announces ALPACAR-360 met primary endpoint

Silence Therapeutics announced topline 36-week data from the ongoing ALPACAR-360 phase 2 study of zerlasiran in 178 subjects with baseline lipoprotein(a), or Lp(a), levels at or over 125 nmol/L at high risk of atherosclerotic cardiovascular disease, or ASCVD, events. Zerlasiran is a siRNA designed to lower the body’s production of Lp(a), a key genetic risk factor for cardiovascular disease affecting up to 20% of the world’s population. In the double-blind placebo-controlled treatment period, zerlasiran was administered at 300 mg subcutaneously every 16 or 24 weeks and 450 mg every 24 weeks to patients with a median baseline Lp(a) of approximately 215 nmol/L. These data demonstrated a highly significant reduction from baseline in Lp(a) compared to placebo to 36 weeks. Median percentage reduction in Lp(a) of 90% or greater were observed for both doses at week 36. No new safety concerns were identified during this treatment period. The 60-week study is ongoing and secondary endpoints, including change in Lp(a) from baseline to 48 weeks, 60 weeks and potential effects on other lipids/lipoproteins, will be evaluated. Silence plans to report topline 48-week data from the ALPACAR-360 study in the second quarter of this year.