Silence's siRNA therapy shows sustained efficacy in cardiovascular study
Clinical ResultPhase 2Phase 1AHA
Silence Therapeutics on Thursday reported positive longer-term data from the Phase II ALPACAR-360 study of its gene silencing therapy zerlasiran (SLN360). The drug demonstrated "highly significant and sustained reductions" in lipoprotein(a) [Lp(a)] levels through 48 weeks in patients with elevated Lp(a) at high risk of atherosclerotic cardiovascular disease events.
The study, involving 178 subjects with baseline Lp(a) levels at or over 125 nmol/L, showed that zerlasiran doses of 300mg subcutaneously every 16 or 24 weeks, or 450mg every 24 weeks, resulted in a median maximum Lp(a) reduction of around 90% or more during the treatment period.
Phase III in the works
"We are encouraged by the strength of the Phase II data and emerging competitive profile of zerlasiran, which support an infrequent dosing regimen of at least quarterly with the 300mg dose," said R&D chief Steven Romano, adding that the company is planning to advance the siRNA into Phase III testing.
These 48-week results build on positive 36-week data announced earlier this year, showing that the study's primary endpoint was met with significant reductions in Lp(a) compared to placebo. Full results from the ALPACAR-360 study will be presented at a future scientific meeting following the study's completion at 60 weeks.
Silence's progress with zerlasiran comes amid a series of positive developments for the company. In February, partner AstraZeneca initiated a Phase I trial for the first product candidate under their 2020 siRNA collaboration, triggering a $10-million milestone payment. Silence is eligible to receive up to $400 million in milestones on each of five targets as part of that deal, which could be extended for another five targets.
IMeanwhile, Silence strengthened its financial position in February with an oversubscribed $120-million private placement, attracting both new and existing institutional investors. The funding has been earmarked for the company's ongoing clinical programmes including zerlasiran, and moving its siRNA therapeutic divesiran (SLN124) into Phase II for polycythemia vera, as well as development of its mRNAi GOLD platform.
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