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Akcea AND IONIS Announce POSITIVE RESULTS FROM PIVOTAL STUDY of volanesorsen IN Patients With Familial Chylomicronaemia Syndrome (FCS)

08 Mar 17

Akcea Therapeutics, a wholly owned subsidiary of Ionis Pharmaceuticals, Inc. (NASDAQ: IONS), today announced that the pivotal Phase 3 APPROACH study of volanesorsen met its primary endpoint of reducing triglyceride levels in patients with familial chylomicronaemia syndrome (FCS).[i]

 

APPROACH is a randomised, double-blind, placebo-controlled, 52-week Phase 3 study in 66 patients with FCS, a rare disease affecting approximately 1-2 in every one million people in the European Union.1,[ii] The mean baseline triglyceride level of patients in the study was 2,209 mg/dL.1 Patients treated with volanesorsen experienced robust reductions in triglycerides and related benefits as follows:

 

·         For the primary endpoint of the study, volanesorsen-treated patients (n=33) achieved a statistically significant (p<0.0001) mean reduction in triglycerides of 77% from baseline after 3 months of treatment, compared to a mean increase of 18% in placebo-treated patients (n=33). This represented a mean absolute reduction of 1,712 mg/dL in treated patients.1

·         Triglyceride-lowering effect was sustained over the 52-week treatment period.1

·         50% of the treated patients who entered the study with triglycerides ≥750 mg/dL achieved triglyceride levels less than 500 mg/dL after 3 months of treatment. By comparison, none of the placebo-treated patients achieved this level (p<0.003).1

·         Volanesorsen-treated patients with the highest documented frequency of pancreatitis attacks suffered no attacks during the 52-week treatment period (p=0.02).1

·         A reduction in abdominal pain was observed in volanesorsen-treated patients compared to placebo-treated patients.1

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