- Ionis Pharmaceuticals Inc IONS announced topline data from the Phase 2b SOLANO study of ION449 (AZD8233) for hypercholesterolemia (high cholesterol levels).
- Ionis said that although the candidate met the primary endpoint, its partners at AstraZeneca Plc AZN have decided not to move it into Phase III studies because the "results did not achieve pre-specified efficacy criteria."
- The trial showed that 60mg of ION449 (AZD8233) administered monthly achieved a statistically significant 62.3% reduction in low-density lipoprotein cholesterol (LDL-C) levels after 28 weeks compared to placebo.
- Also see: AstraZeneca - Ionis Eplontersen Achieves Positive Data In Rare Disease Trial.
- ION449 was generally safe and well tolerated in this study.
- "While the LDL-C reductions seen in high-risk hypercholesterolemia patients on maximum statin therapy were both statistically significant and robust, these results did not meet AstraZeneca's target product profile criteria to invest in a broad Phase 3 development program," said Eugene Schneider, EVP and chief clinical development officer at Ionis.
- The companies did not reveal the effect on PCSK9 levels.
- Price Action: AZN shares are down 2.29% at $55.02, and IONS stock is down 6.58% at $42.01 during the premarket session on the last check Friday.
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