Ionis: AstraZeneca Decides Not To Advance ION449 Into Phase 3 Based On Pre-specified Criteria

Ionis Pharmaceuticals, Inc. (IONS) said topline results from the phase 2bSOLANO study in patients with hypercholesterolemia showed that 60mg of ION449 administered monthly achieved a statistically significant 62.3% reduction in low-density lipoprotein cholesterol levels after 28 weeks compared to placebo, meeting the study's primary efficacy endpoint. However, the results did not achieve pre-specified efficacy criteria and AstraZeneca has decided not to advance ION449 into phase 3 development for hypercholesterolemia.

"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, chief clinical development officer at Ionis.

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