Resolves as YES if the Phase 2 trials of Lepodisiran 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. The specific criteria include:
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 Lepodisiran is safe for participants, with no significant adverse events that would outweigh the benefits. This includes:
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 to Phase 3 trials as determined by the relevant regulatory bodies or the sponsoring company (Eli Lilly).
Background: Lepodisiran is a small interfering RNA (siRNA) therapeutic designed to reduce the production of Lp(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 2 trial (NCT05565742), which started in October 2022, is crucial for determining the drug's efficacy and safety profile. Results are expected to be published by 2025 (American Heart Association) (Cleveland Clinic) (Home - ClinicalTrials.gov).
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