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Silence Therapeutics Finishes Enrolling Zerlasiran Trial of Patients at Cardiovascular Disease Risk

NEW YORK – Biotechnology company Silence Therapeutics announced Monday that it completed enrolling a Phase II study of zerlasiran in people with elevated lipoprotein(a) who are at high risk of atherosclerotic cardiovascular disease (ASCVD) events.

The study, called ALPACAR-360, involves approximately 160 individuals with Lp(a) levels of 125 nmol/L or more who will receive zerlasiran, a GalNAc-conjugated siRNA that targets Lp(a) mRNA in the liver. The primary endpoint is the time-averaged change in Lp(a) from baseline.

Silence is conducting ALPACAR-360 after the Phase I Apollo trial, in which individuals who received a single dose of zerlasiran experienced median maximal Lp(a) reductions of 96 percent and 98 percent when given doses of 300 mg and 600 mg, respectively. After more than 150 days of follow-up, time-averaged reductions in Lp(a) averaged 80 percent in both groups, and zerlasiran was well-tolerated by patients. London-based Silence will report topline data from the multiple dose arm of the Apollo study in the fourth quarter of this year.

Regarding the ALPACAR-360 study, Silence CEO Craig Tooman said that the firm is well ahead of its original timelines and anticipates reporting topline data in mid-2024.