INDIANAPOLIS (dpa-AFX) - Eli Lilly and Co.'s (LLY) Phase 2 trial results revealed that lepodisiran significantly lowered lipoprotein(a) levels, a genetically inherited heart disease risk factor. At the highest tested dose, the drug achieved an impressive reduction of nearly 94% from baseline in adults with elevated levels.
Lepodisiran is an investigational small interfering RNA (siRNA) therapy designed to lower the production of lipoprotein(a) [Lp(a)], a genetically inherited risk factor for heart disease.
According to the company, lepodisiran significantly reduced Lp(a) levels in the Phase 2 ALPACA study by an average of 93.9% over the 60 to 180-day period after treatment with the highest tested dose (400 mg), meeting the primary endpoint. Participants who received the 16 mg and 96 mg lepodisiran doses experienced a 40.8% reduction and a 75.2% reduction in Lp(a) levels over the same time period, respectively.
The company noted that Lepodisiran also met additional secondary endpoints, showing reductions in Lp(a) levels following one or two administrations of each of the three tested doses across all timepoints assessed throughout the nearly 18-month-long study. Lepodisiran was administered twice at each dose (16 mg, 96 mg, or 400 mg), once at baseline and at day 180, with a separate group receiving 400 mg at baseline and placebo at day 180. The effect of additional doses of lepodisiran remains undetermined.
Results from additional secondary endpoints showed that participants who received 400 mg of lepodisiran at both baseline and day 180 experienced a 94.8% reduction in average Lp(a) levels over the day 30 to 360 period, which remained 91.0% below baseline at about 1 year and 74.2% below baseline at about 1.5 years).
Lepodisiran also reduced apolipoprotein B (apoB) levels, a separate cholesterol biomarker. The highest dose (400 mg) of lepodisiran showed 14.1% and 13.7% ApoB reductions from baseline at day 60 and 180, respectively. A second 400 mg lepodisiran dose at day 180 sustained these apoB reductions through day 540.
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