Ionis provides update on development program evaluating PCSK9 antisense medicine for the treatment of hypercholesterolemia
2022-09-23 · Ionis Pharmaceuticals · original ionis.com ↗
ION449 (AZD8233) met primary endpoint in Phase 2b SOLANO study for patients with hypercholesterolemia ION449 will not advance into Phase 3 development based on pre-specified criteria CARLSBAD, Calif., Sept. 23, 2022 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced that topline results from the Phase 2b SOLANO study in patients with hypercholesterolemia demonstrated that 60mg of ION449 (AZD8233) administered monthly achieved a statistically significant 62.3% (p<0.001) reduction in low-density lipoprotein cholesterol (LDL-C) levels after 28 weeks compared to placebo, meeting the study's primary efficacy endpoint. ION449 was generally safe and well tolerated in this study. However, these results did not achieve pre-specified efficacy criteria and AstraZeneca has decided not to advance ION449 (AZD8233) into Phase 3 development for hypercholesterolemia. AstraZeneca is continuing to analyze the results from the SOLANO study to determine its next steps for the program.
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