US-based pharmaceutical company Akcea Therapeutics has reported positive results from its Phase II study of volanesorsen to treat patients with high-plasma triglyceride (TG) levels and type 2 diabetes (T2D).
Volanesorsen is an antisense drug being developed to treat patients with severely high triglycerides and is administered either as a single agent or in combination with other triglyceride-lowering agents.
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It can reduce the production of ApoC-III, a protein produced in the liver instrumental in regulating plasma triglycerides.
The double-blind, placebo-controlled Phase II trial included 15 patients and they were administered with a weekly subcutaneous treatment with 300mg of volanesorsen or placebo (2:1) for 13 weeks.
Results exhibited a reduced ApoC-III and TG levels in patients treated with volanesorsen with increased insulin sensitivity.
Improvements in markers of glycemic control were additionally observed coupled with a decreased glycated albumin and fructosamine after three months of dosing, and a decrease in HbA1C post three months dosing.
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By GlobalDataThe trial recorded no clinically relevant changes in blood serum chemistries, hematology, urinalysis, inflammatory markers, electrocardiogram, or vital signs.
Akcea chief medical officer Dr Louis O’Dea said: "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."
Volanesorsen is currently being evaluated in two Phase III registrational studies (APPROACH FCS and BROADEN FPL), as well as a third Phase III trial (COMPASS) intended to support global regulatory filings.
