XTL Biopharmaceuticals Announces Completion of Patient Randomization Into the Bicifadine Phase 2b Clinical Trial for the Treatment of Diabetic Neurop...( VALLEY COTTAGE N.Y. June 30 /- XT...),Health

VALLEY COTTAGE, N.Y., June 30 /PRNewswire-FirstCall/ -- XTL Biopharmaceuticals Ltd. (Nasdaq: XTLB; TASE: XTL) today announced that it has completed patient randomization into its Phase 2b study of Bicifadine -- a serotonin and norepinephrine reuptake inhibitor (SNRI) -- for the treatment of diabetic neuropathic pain. 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 4 months.

The Phase 2b 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(R), a member of the SNRI class that is approved for this indication, and other approved agents for neuropathic pain.

The Phase 2b study is a randomized, double-blind, placebo-controlled study comparing 200mg 3x/day (tid) and 400mg 3x/day (tid) 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 United States, Germany, Israel and India are participating in the study. Following randomization, all patients enter a 2-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). Pain is measured based on a 24-hour pain rating using the
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