July 1, 2008
XTL Completes Patient Randomization in Phase IIb Study of Diabetic Pain Drug
XTL Biopharmaceuticals has completed patient randomization into its Phase IIb study of Bicifadine - a serotonin and norepinephrine reuptake inhibitor - for the treatment of diabetic neuropathic pain.
Approximately 350 patients were randomized into the study. Based on the completion of randomization, the company expects to have the last patient complete the study in the next four months.
The Phase IIb trial is aimed at demonstrating the efficacy of Bicifadine in diabetic neuropathic pain, using a study design that is similar to the successful registration trials of Cymbalta, a member of the SNRI class that is approved for this indication, and other approved agents for neuropathic pain.
The Phase IIb study is a randomized, double-blind, placebo-controlled study comparing 200mg 3x/day and 400mg 3x/day of Bicifadine versus placebo, with a 1:1:1 randomization between the three arms, in patients with diabetic neuropathic pain. Approximately 40 clinical centers in the US, Germany, Israel and India are participating in the study.
Following randomization, all patients enter a two-week titration period to allow them to gradually escalate up to their target treatment dose. This is followed by a 12-week steady-state treatment period at the target treatment dose.
The primary endpoint of the study is to compare the efficacy of each of the two active doses of Bicifadine (200mg tid and 400mg tid) versus placebo in reduction of pain associated with diabetic neuropathy, at baseline (at the time of randomization) versus week 14 (week 12 of the steady-state phase).