Spinifex Announces Positive Phase 2 Results for EMA401 in Postherpetic Neuralgia
Trial Meets Primary Endpoint: Reduction in Pain
Spinifex Pharmaceuticals announces positive headline results from the Phase 2 clinical trial of its lead product, EMA401, in postherpetic neuralgia (PHN), a painful condition that develops in some patients following herpes zoster (shingles) and where existing therapy does not relieve pain in all individuals.
The clinical trial met its primary endpoint, reduction in mean daily pain score versus placebo over the last week of 28 days of treatment. Results show a statistically significant and clinically meaningful reduction in mean pain intensity from baseline to week 4 for subjects on active treatment when compared to placebo. On an intent to treat basis, the mean pain intensity reduction from baseline after 4 weeks treatment was as follows: EMA401: -2.34; Placebo: -1.64; p = 0.006.
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) (EMA401: 56.5%; Placebo: 34.1%; p = 0.003), meeting a key secondary endpoint.
EMA401 was generally safe and well tolerated with no serious treatment related adverse events reported.
The double-blind, placebo-controlled randomised trial was recruited at 29 centres in six countries and enrolled 183 patients.
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