Neuren posts favorable data for cardio compound

Neuren’s phase IIa clinical trial investigated the safety, tolerability and pharmacokinetics of a four-hour infusion of Glypromate in 33 cardiac surgery patients. Of these, 12 patients received 3mg/kg/hr, 11 received 1mg/kg/hr and 10 received placebo.

Patients infused at the lower dose achieved blood levels of Glypromate of 960ng/mL and those infused at the three-fold higher dose had a maximal level of 3,508ng/mL. The study therefore confirmed a linear relationship between dose and exposure, such that a three-fold increase in dose corresponded to a three-fold increase in exposure of the patient to the drug.

This type of relationship is desirable because it enables clinicians to predict the exposure of the patient to different doses of the drug. Non-linear pharmacokinetics can lead to poor predictability of exposure to a particular dose.

At both doses, Glypromate displayed an elimination half-life of two to three minutes, meaning that the concentration of Glypromate in the blood halved every two to three minutes. This is in line with previous predictions. It also adds to the safety profile of the drug in that it departs the body rapidly after the time it is needed.

Neuren also revealed that it is in the final stages of choosing key centers across the US, Australia and New Zealand to participate in its upcoming phase III trial.