Ionis stock dips as AstraZeneca decides not to move cholesterol drug in phase 3 after mid-stage disappoints
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Ionis Pharmaceuticals (NASDAQ:IONS) said AstraZeneca (NASDAQ:AZN) will not advance ION449 (AZD8233) into phase 3 development for hypercholesterolemia after the antisense medicine did show the required efficacy in a phase 2b study.
The phase 2b trial, dubbed SOLANO, was evaluating ION449 versus placebo in 411 patients with hypercholesterolemia â high levels of low-density lipoprotein cholesterol (LDL-C, also known as bad cholesterol). These participants had hyperlipidemia LDL-C â¥70 mg/dL and <190mg/dL and on maximum tolerated statin and/or ezetimibe.
The study met its main efficacy goal, as 60mg of ION449 (AZD8233) given monthly achieved a statistically significant 62.3% reduction in LDL-C levels after 28 weeks compared to placebo. However, these results did not achieve pre-specified efficacy criteria, Ionis said in a Sept. 23 press release.
In April, ION449 had met the main goal of a phase 2 study called ETESIAN by reducing serum LDL-C levels by up to 79%.
Ionis added that ION449 was generally safe and well tolerated in the SOLANO 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, executive vice president, chief clinical development officer, Ionis.
AstraZeneca is analyzing the results from the SOLANO study to decide its next steps for the program, Ionis noted.
IONS -4.16% to $43.10 premarket Sept. 23