NicOx moves diabetes drug into phase II

The company expects to initiate two phase II studies within the next six months. The trials will have the goal of confirming the mechanism of action of NCX 4016 as an insulin sensitizer and demonstrating a clinical benefit in the treatment of type 2 diabetes.

The decision to initiate 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. A good safety and tolerability profile has also been demonstrated in long-term treatment.

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 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 and blood glucose in the fasting state and after meals.

“In light of the type 2 diabetes pandemic that is appearing in the developed world, there is a clear need for a new class of oral treatments which could counteract insulin resistance through an alternative mechanism,” said Maarten Beekman, vice president of clinical development at NicOx. “There is a solid scientific rationale supporting the development of NCX 4016 as an insulin sensitizing agent, based on the known effects of nitric oxide and salicylate and the recent finding that NCX 4016 releases higher and more sustained levels of salicylate than previously thought.”