Resolves as YES if the Phase 3 trials of Olpasiran demonstrate:
Efficacy:
The trials must show a statistically significant reduction in lipoprotein(a) [Lp(a)] levels in participants compared to baseline, achieving at least a 50% reduction in median Lp(a) levels.
A high percentage of participants achieving Lp(a) levels below 125 nmol/L and 75 nmol/L.
Consistent reduction of Lp(a) levels maintained over the trial period.
Safety:
The trials must confirm that Olpasiran is safe for participants, with no significant adverse events that would outweigh the benefits.
Minimal and manageable side effects.
Few serious adverse events linked to the drug's administration.
Regulatory Progress:
The trial results must be sufficient to warrant progression towards regulatory approval, as determined by the relevant regulatory bodies or the sponsoring company (Amgen).
Background: Olpasiran is a small interfering RNA (siRNA) therapeutic designed to reduce the production of apolipoprotein(a) in the liver by targeting the mRNA that encodes apolipoprotein(a). Elevated Lp(a) levels are a known risk factor for atherosclerotic cardiovascular disease (ASCVD), and effective reduction of these levels could significantly impact patient outcomes.
The ongoing Phase 3 trial, which began in January 2023, aims to confirm the promising results observed in earlier phases. This trial is crucial for determining the long-term efficacy and safety profile of Olpasiran, with results expected to be published around 2025.