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– ETESIAN Phase 2b study of ION449 (AZD8233) met its primary and secondary endpoints; ION449 was generally well tolerated
– ION449 demonstrated potential best-in-class efficacy profile for a self-administered subcutaneous monthly dose regimen
– Study findings warrant further clinical development of ION449 for patients with hypercholesterolemia at high cardiovascular risk
CARLSBAD, Calif., April 4, 2022 /PRNewswire/ — Ionis Pharmaceuticals, Inc. (NASDAQ:IONS), the leader in antisense therapeutics, and its partner, AstraZeneca, today announced positive data from the ETESIAN Phase 2b study of ION449 (AZD8233), an investigational antisense medicine designed to reduce blood cholesterol levels in patients with hypercholesterolemia by targeting proprotein convertase subtilisin/kexin type 9 (PCSK9). These data were presented at the American College of Cardiology’s 71st Annual Scientific Session & Expo .
The ETESIAN Phase 2b study’s objective was to assess the efficacy, safety and tolerability of ION449 in patients with high-risk hypercholesterolemia. The study met its primary endpoint in reducing serum LDL-C levels by up to 79% statistically. Both the 50mg and 90mg doses reached significant and clinically meaningful reductions in LDL-C levels from baseline of 73% (95% confidence interval [CI]: 77%, 68%) and 79% (95% CI: 83%, 76%), respectively, versus 2% (95% CI: 17%, -15%) for placebo. The reductions in LDL-C were maintained until week 14 (6 weeks after the last dose).
The trial also met the secondary endpoints, including significantly reducing PCSK9 levels by up to 94%. The 50mg and 90mg doses achieved reductions in PCSK9 levels of 89% (95% CI: 91%, 86%) and 94% (95% CI : 95%, 92%), respectively, versus 5% (95% CI: 23%, -18%) for placebo. The sustained reductions in PCSK9 levels were maintained until week 14 (6 weeks after last dose). Reducing PCSK9 levels leads to lower LDL-C levels in the bloodstream, which is known to reduce the risk of …
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