Teva, Xenon Announce Phase II Study of Topical TV-45070 Did Not Meet Primary Endpoint

Teva Pharmaceutical and Xenon Pharmaceuticals announce top-line results in a Phase II study of topical TV-45070 in patients with post-herpetic neuralgia (PHN) did not meet the primary endpoint of a statistically significant change in pain from baseline to week four as assessed by the numeric rating scale (NRS). Secondary endpoints were also not met. There were no safety concerns in the study.

This was a Phase II proof of concept study seeking to understand the potential for a topical route of Nav1.7 blockade in PHN.

"While these results are disappointing for us from a scientific perspective and for patients needing new therapies to treat chronic neuropathic pain, Xenon remains focused on advancing its pipeline of neurology-related development candidates, with multiple programs anticipated to enter clinical development in 2017," Dr. Simon Pimstone, Xenon’s President and Chief Executive Officer, said.

The companies plan to further analyze the data from this study to determine the next steps for TV-45070, and may look to present study data at a relevant forthcoming scientific conference.

TV-45070 is a small-molecule inhibitor of the sodium channel Nav1.7, and other sodium channels, expressed in the pain-sensing peripheral nervous system. TV-45070 was licensed by Xenon to Teva in December 2012.

This Phase II trial was a randomized, double-blind, placebo controlled, parallel group, multicenter study to evaluate the efficacy and safety of TV-45070 in patients with PHN. The study included three treatment groups that received topical ointment containing 4 percent or 8 percent TV-45070 or placebo, dosed twice daily. The primary endpoint of this study was the change of average daily pain scores from baseline to week four, measured using an 11-point (0-10) numeric rating scale (NRS).

Secondary endpoints included the percentage of patients with greater than 30 percent and greater than 50 percent improvement in pain scores, quality of life measurements and adverse events measurements. The study was carried out at 48 centers in the US and involved 300 patients randomized to 100 patients receiving 4 percent TV-45070, 100 patients receiving 8 percent TV-45070 and 100 patients receiving placebo.