Isis Pharmaceuticals, Inc. (ISIS) recently presented interim data on its cholesterol management candidate, ISIS-APOCIIIRx, from an ongoing phase II study. The double-blind, randomized, placebo-controlled 13-week study is evaluating ISIS-APOCIIIRx’ safety and activity as a monotherapy in patients with very high to severely high triglycerides.
Data showed that patients receiving ISIS-APOCIIIRx achieved statistically significant mean reductions of up to 79% in apolipoprotein C-III (apoC-III) and up to 75% in triglycerides. Moreover, statistically significant mean increases of up to 57% in good cholesterol levels (high-density lipoprotein cholesterol (HDL-C)) were observed. Up to 89% mean reduction in apoC-III-associated very low-density lipoprotein (:VLDL) particles was also achieved.
ISIS-APOCIIIRx is one of the most promising candidates in Isis Pharma’s pipeline. Earlier this year in June, Isis Pharma had reported impressive results from a phase II study on ISIS-APOCIIIRx at the American Diabetes Association (:ADA).
Results showed that ISIS-APOCIIIRx reduced triglyceride levels and increased good cholesterol levels in type II diabetes patients with high triglycerides. Patients in the ISIS-APOCIIIRx arm saw an 88% reduction in apoC-III, a 72% reduction in triglyceride levels and a 40% improvement in good cholesterol levels.
Isis Pharma reported improvement in other lipid parameters as well as several measures of glucose control. The candidate’s safety profile was also good with no discontinuations, clinically meaningful elevations in liver enzymes, flu-like symptoms, or major adverse events being reported.
The phase II data is encouraging and we look forward to updates on the company’s future development plans for the candidate. Isis Pharma intends to enter into discussions with regulatory agencies regarding phase III plans and move the candidate into phase III development in 2014 in patients with severely high triglycerides.
Isis Pharma currently carries a Zacks Rank #3 (Hold). The next 12-18 months should be catalyst-rich with Isis Pharma expected to report results from several studies.
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