EMA 401 results in Post Herpetic Neuralgia are published in The Lancet- Spinifex Pharma

Spinifex Pharmaceuticals announced that The Lancet has published the results of its Phase II clinical trial of its lead candidate, EMA 401, in Postherpetic Neuralgia (PHN). EMA401 is a novel angiotensin II type 2 (AT2) receptor antagonist under development as a potential first-in-class oral treatment for chronic pain without CNS side effects. PHN is a painful condition that develops in some patients following herpes zoster (shingles) and where existing therapy does not relieve pain in all individuals.

The Phase II trial met its primary endpoint by showing that patients randomised to EMA 401 achieved a greater reduction in pain from baseline to the last week of 28 days of treatment than patients randomised to placebo. Analysing all patients randomised (intent to treat population), the mean pain intensity reduction from baseline after 4 weeks treatment was as follows: EMA401: -2.29; Placebo: -1.60; p = 0.007. A significantly greater proportion of patients on active treatment reported a more than 30% reduction in mean pain intensity score compared to baseline (i.e. responder rate) (EMA 401: 57.6%; Placebo: 35.2%; p = 0.0023), meeting a key secondary endpoint.

See-EMA401, an orally administered highly selective angiotensin II type 2 receptor antagonist, as a novel treatment for postherpetic neuralgia: a randomised, double-blind, placebo-controlled phase 2 clinical trial, Rice, A.S.C. et al., The Lancet, Published Online, February 5, 2014; http://dx.doi.org/10.1016/S0140-6736(13)62337 .