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Isis Reports Interim Phase 2 Data on ISIS-APOCIII Rx as a Single Agent in Patients With Very High to Severely High Triglycerides
Date:8/31/2013

e potential to fill this need."

The monotherapy portion of the ongoing Phase 2 study of ISIS-APOCIIIRx is a double-blind, randomized, placebo-controlled 13-week study designed to assess the safety and activity of ISIS-APOCIIIRx in patients with very high to severely high triglyceride levels (between 440 and 2,000 mg/dL).  The data reported today is an interim analysis of 28 patients who completed 13 weeks of treatment with ISIS-APOCIIIRx or placebo.  In this study, patients treated with ISIS-APOCIIIRx experienced dose-dependent, robust and prolonged, mean percent reductions from baseline in apoC-III, triglycerides and apoC-III-associated VLDL particles.  Furthermore, these patients demonstrated a rapid, prolonged and statistically significant mean percent increase from baseline in HDL-C.Table 1:  ISIS-APOCIIIRx Produced Statistically Significant Reductions of Triglycerides, ApoC-III and ApoC-III-associated VLDL as a Single Agent in a Phase 2 Study in Patients with Very High to Severely High Triglyceride Levels.  Mean % Changes From Baseline at Primary Endpoint.*Placebo 

(n=9)

ISIS-APOCIIIRx

100 mg  (n=9)

ISIS-APOCIIIRx

200 mg  (n=5)

ISIS-APOCIIIRx

 300 mg
(n=5)ApoC-III

+5%

-43%

(p=0.04)

 -72%

(p=0.004)

 -79%

(p=0.003)Triglycerides

+26%

-31%

(p=0.08)

-65%

(p=0.02)

-75%

(p=0.004)ApoC-III VLDL

+19%

-27%

(p=0.17)

 -73%

(p=0.003)

 -89%

(p=0.004)HDL-C

+3%

+30%

(p=0.08)

 +51%

(p=0.002)

 +57%

(p=0.001)non-HDL

+17%

-8%

(p=0.16)

-5%

(p=0.36)

-39%

(p=0.007)P value = vs
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SOURCE Isis Pharmaceuticals, Inc.
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