XTL Biopharmaceuticals Completes Phase IIb Diabetic Neuropathic Pain Study
XTL Biopharmaceuticals, a developer of therapeutics for the treatment of diabetic neuropathic pain and hepatitis C virus, has announced that the last patient randomized into the Bicifadine Phase IIb clinical trial for the treatment of diabetic neuropathic pain has completed the study.
This milestone officially marks the completion of this randomized, double-blind, placebo-controlled Phase IIb clinical trial which enrolled 351 patients at approximately 40 sites in the US, Germany, Israel and India. The company expects to report top-line results from this study within six to eight weeks.
The Phase IIb trial is a randomized, double-blind, placebo-controlled study comparing 200mg 3x/day (tid) and 400mg (tid) of Bicifadine versus placebo, with a 1:1:1 randomization between the three arms, in patients with diabetic neuropathic pain. Following randomization, all patients entered a two-week titration period to allow them to gradually escalate up to their target treatment dose.
This was 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 versus week 14 (week 12 of the steady-state Phase).
Ron Bentsur, CEO of XTL Biopharmaceuticals, said: “The completion of the Bicifadine Phase IIb clinical trial is an important and significant milestone for XTL. We are grateful for the dedication of all the investigators who participated in the study, and we look forward to reporting top-line data from the study later this quarter.”