NicOx to start two NCX 4016 diabetes trials

By Elaine Rigoli

Tampa, Fla., July 26 - NicOx SA announced its decision to move NCX 4016 forward in clinical development as a novel insulin sensitizing agent for the treatment of type 2 diabetes and expects to begin two phase 2 studies within the next six months.

The first study is projected to be a single-center, cross-over trial designed to confirm the mechanism of action of NCX 4016 as an insulin sensitizing agent using a hyperinsulinemic euglycemic clamp, the same technique used in the 13-patient phase 2a trial conducted in 2005. The results showed a statistically significant improvement in insulin sensitivity following treatment with NCX 4016, as compared to baseline, the company said in a news release.

The second trial is projected to be a placebo and active controlled, double-blind, parallel study aiming to demonstrate a clinical benefit for NCX 4016 through the measurement of HbA1c (glycosylated hemoglobin, the gold standard test for glycemic control in diabetics) and blood glucose in the fasting state and after meals.

The decision to begin this clinical program follows the encouraging results obtained in type 2 diabetes patients in three previously announced trials for NCX 4016 in the cardiometabolic setting, the release said.

NicOx is a biopharmaceutical company with headquarters in Sophia-Antipolis, France.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.