Teva and Xenon’s Phase II trial of TV-45070 for PHN fails to meet endpoints

27th June 2017 (Last Updated June 27th, 2017 18:30)

Teva Pharmaceutical Industries and Xenon Pharmaceuticals have reported top-line data from a Phase II clinical trial of TV-45070 to treat patients suffering from post-herpetic neuralgia (PHN), with the drug failing to meet required endpoints.

Teva Pharmaceutical Industries and Xenon Pharmaceuticals have reported top-line data from a Phase II clinical trial of TV-45070 to treat patients suffering from post-herpetic neuralgia (PHN), with the drug failing to meet required endpoints. 

TV-45070 is a small-molecule inhibitor of sodium channels such as Nav1.7 that are expressed in the pain-sensing peripheral nervous system. 

Results showed that the trial has failed to meet both the primary and secondary endpoints, but TV-45070 did not demonstrate any safety concerns. 

The proof-of-concept, randomised, double-blind, placebo controlled, parallel group, multi-centre Phase II trial assessed the efficacy and safety of topical 4% and 8% twice daily TV-45070 in 300 patients at 48 US clinical sites.

"Xenon remains focused on advancing its pipeline of neurology-related development candidates, with multiple programmes anticipated to enter clinical development in 2017."

Xenon Pharmaceuticals president and CEO Dr Simon Pimstone said: "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 programmes anticipated to enter clinical development in 2017."

Xenon had licensed TV-45070 to Teva Pharmaceutical in December 2012.

Phase II trial's  primary endpoint was a statistically significant change in pain from baseline to week four as measured using the numeric rating scale (NRS). 

The trial’s secondary endpoints were the percentage of patients with pain score improvements greater than 30% and more than 50% measured quality of life and adverse events.

The firms intend to further analyse Phase II results to establish a future course of development for TV-45070.