AstraZeneca Blocks Ionis’ Hypercholesterolemia Treatment from Moving into a Phase 3 Study

by Max Heirich
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Ionis Pharmaceuticals announced topline results from its Phase 2b SOLANO study evaluating ION449 (AZD8233) on September 23. Administered to patients with hypercholesterolemia, the treatment reduces low-density lipoprotein cholesterol (LDL-C). Despite the positive results, AstraZeneca decided against moving ION449 into Phase 3 development. 

Related Article: AstraZeneca, Ionis’ ATTR Drug Edges Closer to US Approval With Latest Trial Win

ION449’s Proven Reduction of Cholesterol

Developed by Ionis, LIgand-Conjugated Antisense (LICA) is a chemical technology platform that allows for the specific binding of ligand molecules to the receptors of cells. As a result, LICA enables effective antisense drug delivery for these particular receptors.

Using the LICA technology platform, ION449 reduces plasma levels of proprotein convertase subtilisin/kexin type 9 (PCSK9) via once-monthly subcutaneous injection. PCSK9 plays a part in the control of the number of low-density lipoprotein(LDL) receptors, a protein found on cell surfaces. These receptors bind to LDL-C particles primarily responsible for carrying cholesterol in the blood. Studies have shown that lower LDL-C levels substantially reduce the risk of cardiovascular disease.

Patients with elevated levels of LDL-C, a disease called hypercholesterolemia, are at a high risk of cardiovascular disease. The SOLANO Phase 2b study treated hypercholesterolemia patients with ION449. Overall, there was a 62.3% reduction in LDL-C levels as compared to placebo at week twenty-eight. In addition, the drug was generally safe and well tolerated.

However, despite the significant positive results, AstraZeneca decided against moving the hypercholesterolemia treatment into Phase 3 development. 

AstraZeneca’s Decision and Options Moving Forward

In 2015, AstraZeneca and Ionis (then known as Isis Pharmaceuticals) signed a $65 million deal to develop antisense drugs for cardiovascular, metabolic, and renal diseases. Once drug born of this deal was ION449.

Though ION449 met SOLANO’s primary endpoint, it fell short of pre-specified efficacy criteria. As a result, AstraZeneca refused ION449’s advancement into further development. 

On AstraZeneca’s decision, Eugene Schneider, M.D., executive vice president and chief clinical development officer at Ionis, said, “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.”

Schneider then asserted the continuation of their collaboration with AstraZeneca, with optimism of advancing other programs of importance. At the time of writing, AstraZeneca hasn’t commented. However, Ionis claims their partner will continue their analysis of SOLOANO’s results to determine the next steps for ION449.

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