Akcea Therapeutics & Ionis Pharmaceuticals (IONS) announce 'positive' topline results from a Phase 2 clinical study of AKCEA-APO(a)-LRx in patients with established cardiovascular disease and elevated levels of lipoprotein
Results from the study show:
- Statistically significant dose-dependent reductions of Lp(a) compared to placebo at all dose levels, including low monthly doses of AKCEA-APO(a)-LRx.
- Most patients in the active group achieved Lp(a) reductions below the established threshold of risk for CVD events.
- Treatment emergent adverse events were balanced between the active and placebo groups.
- Most common adverse event was injection site reactions (ISRs). ISRs were mostly mild and occurred in a minority of patients.
- No patient in the study experienced a confirmed platelet level below 100,000/mm3. The incidence of platelet levels below normal (140,000/mm3) was comparable between the active (10.5%) and placebo (14.9%) groups.
- Approximately 90% of patients completed treatment and the rate of treatment discontinuation was comparable between the active and placebo groups.
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