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Isis Reports Phase 2 Data on ISIS-APOCIII Rx Showing Substantial Reductions of Triglycerides and Apoc-III in Patients with Familial Chylomicronemia
Date:9/21/2013

Reductions of Triglycerides and ApoC-III as a Single Agent in a Phase 2 Study in Patients with FCS and Severely High Triglyceride Levels.  Patient 1

(485 mg/dL lowest TG)**

Patient 2

(251 mg/dL lowest TG)**

Patient 3

(234 mg/dL lowest TG)**

Mean %

ChangeBaseline

(mg/dL)

Primary Endpoint (mg/dL)

* % Change

Baseline

(mg/dL)

Primary Endpoint (mg/dL)

*% Change

Baseline

(mg/dL)

Primary Endpoint (mg/dL)

*% ChangeTriglycerides

1406

617

-56.2

2083

288

-86.2

2043

735

-64.0

-69ApoC-III

18.9

5.5

-70.9

35.1

3.4

-90.4

19.8

3.5

-82.5

-81VLDL-ApoC-III

12.2

4.5

-63.5

32.6

2.5

-92.2

16.8

2.3

-86.3

-81HDL-C

16

24

+50

8

21

+162.5

14

17

+21.4

+78Non-HDL-C

214

115

-46.5

327

84

-74.3

244

111

-54.5

-58*Percent changes from baseline at primary endpoint (an average measurement of day 85 and 92)

** Lowest triglyceride level achieved during study

Consistent with the previously reported studies, ISIS-APOCIIIRx demonstrated a good safety profile and was well tolerated.  The most common adverse event was injection site reactions, which were predominantly mild and typically resolved rapidly.  There were no flu-like symptoms, no treatment-related elevations of liver enzymes greater than three times upper limit of normal, no abnormalities in renal function, no clinically meaningful changes in other laboratory values and no treatment related serious adverse events.
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SOURCE Isis Pharmaceuticals, Inc.
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