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Isis Pharmaceuticals Updates Its Positive Phase 2 Data for ISIS,301012 in Familial Hypercholesterolemia Patients

ally to assess the safety of ISIS 301012 in HoFH and in combination with high-dose concurrent lipid-lowering therapies, the protocol initially called for five weeks of dosing. Based on a strong safety profile at five weeks with doses through 200 mg/week, the study was amended to include a cohort of patients dosed at 300 mg/week for three months, and it is that cohort for which Isis is updating the interim data presented at the ACC. Because HoFH is an extremely rare condition affecting one person per million, clinical trials in this disease are generally quite small.

The study included three HoFH patients with very high incoming LDL-cholesterol levels despite being treated with maximally-tolerated lipid-lowering therapies. Throughout the study, all patients remained on their other lipid-lowering drugs at constant doses. With this update, all patients completed 12 weeks of study treatment and reached the primary endpoint for analysis at Day 99, 14 days after receiving their last dose of ISIS 301012. The patients continue in follow-up. The data are summarized in tabular form below.



    Table 1: ISIS 301012 in HoFH, Summary of Results

    Lipid values are presented in mg/dL and % change from baseline.


                  Patient 1         Patient 2          Patient 3


                                      80 mg

                                   atorvastatin +

    Concurrent                   10 mg ezetimibe +

    Lipid-                            3.75 g              40 mg

    lowering        80 mg          colesevelam +      rosuvastatin +

    Therapies    atorvastatin       1 g niacin        10 mg ezetimibe


    Age

     (years)        23                  48                  32


    Lipids: Base-   Day    %     Base- Day    %     Base-  Day    %

            line    99   change  line  99   change  line   99   change

    ApoB     369    171   -54%   180   103   -43%   283    156   -45%

    LDL-C    651    318   -51%   197    99   -50%   4
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