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AstraZeneca Pulls Plug On Ionis Pharma-Partnered Cholesterol Med

  • Ionis Pharmaceuticals Inc (NASDAQ: IONSannounced 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 (NASDAQ: 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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