Akcea reports positive Phase II trial results of volanesorsen to treat high TG levels and T2D

27th June 2016 (Last Updated June 27th, 2016 18:30)

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).

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.

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."

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.

The 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.