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Akcea and Ionis (IONS) Announce Positive Results from COMPASS Phase 3 Study of Volanesorsen

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  • For the primary endpoint of the study, volanesorsen-treated patients (n=75) achieved a statistically significant (p<0.0001) mean reduction in triglycerides of 71.2% from baseline after 13 weeks of treatment, compared with a mean reduction of 0.9% in placebo-treated patients (n=38).  This represented a mean absolute reduction of 869 mg/dl in treated patients.  The treatment effect observed was sustained through the end of the 26 week treatment period.
  • In a subset of seven patients with familial chylomicronemia syndrome (FCS), whose average incoming triglyceride level was 2,280 mg/dl, volanesorsen-treated patients (n=5) achieved a mean reduction in triglycerides of 73% from baseline after 13 weeks of treatment, compared with a mean increase of 70% in placebo-treated patients (n=2).  This represented a mean absolute reduction of 1,511 mg/dl in treated patients.  The treatment effect observed was sustained through the end of the 26-week treatment period.
  • In addition, 82% of patients treated with volanesorsen, including three of the FCS patients, achieved triglyceride levels less than 500 mg/dl after 13 weeks of treatment, compared to 14% of placebo-treated patients (p<0.0001).
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    Occurred on:
    Dec 19, 2016
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    Related Keywords Volanesorsen, Phase 3, Compass