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Akcea Announces Publication of Positive Volanesorsen Clinical Data Showing Reduced Triglycerides and Improved Insulin Sensitivity in Patients with High Triglycerides and Type 2 Diabetes

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Clinical Data The paper titled "Antisense-Mediated Lowering of Plasma Apolipoprotein C-III by Volanesorsen Improves Dyslipidemia and Insulin Sensitivity in Type 2 Diabetes" (Digenio et al., Diabetes CareJune 2016) reported data from a Phase 2 double-blind, placebo-controlled study in fifteen patients randomized to weekly subcutaneous treatment with 300 mg of volanesorsen or placebo (2:1) for 13 weeks. In patients treated with volanesorsen, ApoC-III and TG levels decreased on average 88% and 69%, respectively, compared to baseline, and HDL-cholesterol increased an average of 42%. In addition, insulin sensitivity increased an average of 50% and correlated well with reductions in both plasma ApoC-III (r = -0.61, p=0.03) and TG (r = -0.68, p=0.01).  In addition, improvements in markers of glycemic control were observed, including statistically significant decreases in glycated albumin and fructosamine after three months of dosing, and a decrease of 0.44 percentage points in HbA1C observed three months post-dosing. The majority of adverse events reported in both groups in the study were mild in severity with no discontinuations from the study due to adverse events. There were no clinically relevant changes in blood serum chemistries, hematology, urinalysis, inflammatory markers, electrocardiogram, or vital signs."One of the most interesting findings in this study was that, in volanesorsen-treated patients with high triglycerides, substantial reductions in ApoC-III and triglycerides led to improved insulin sensitivity and glucose control. This is different from what is observed with currently approved triglyceride-lowering medications, which are not typically associated with this effect," said Dr. Louis O'Dea, Akcea's chief medical officer.
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Jun 27, 2016
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Related Keywords Broaden Fpl Study, Approach Fcs Study, Volanesorsen, Triglycerides, High Triglycerides, Type 2 Diabetes, Familial Chylomicronemia Syndrome, Familial Partial Lipodystrophy