- Ionis Pharmaceuticals Inc IONS announced topline dates from the Phase 2b SOLANO study of ION449 (AZD8233) in hypercholesterolaemia (high cholesterol).
- Ionis said that although the candidate met the primary endpoint, its partners at AstraZeneca Plc AZN decided not to advance it to phase III trials because the “results did not meet pre-established efficacy criteria.”
- The study showed that monthly administration of 60 mg of ION449 (AZD8233) produced a statistically significant 62.3% reduction in low-density lipoprotein-cholesterol (LDL-C) levels compared to placebo at 28 weeks.
- See also: AstraZeneca – Ionis Eplontersen achieves positive data in rare disease study.
- ION449 was generally safe and well tolerated in this study.
- “While the LDL-C reductions observed in high-risk hypercholesterolemic patients receiving maximal statin therapy were both statistically significant and robust, these results did not meet the criteria of AstraZeneca’s target product profile to invest in a broad Phase 3 development program” , said Eugene Schneider, EVP and Chief Clinical Development Officer at Ionis.
- The companies have not disclosed the impact on PCSK9 values.
- Price promotion: AZN shares are down 2.29% to $55.02 and IONS shares are down 6.58% to $42.01 during the premarket session last check Friday.
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