MELBOURNE, Australia,
Trial Meets Primary Endpoint: Reduction in Pain
Spinifex Pharmaceuticals, an Australian pain drug development company, today 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. More details on the trial design and results can be found in the appendix.
Spinifex will be presenting an overview of the clinical development of EMA401 today at the 14th World Congress of Pain in Milan, a major international meeting organised by the International Association for the Study of Pain (IASP). Full results of the Phase 2 trial are expected to be published in a leading pain clinical research journal.
Dr Milton Raff (Christiaan Barnard Memorial Hospital, Cape Town, South Africa), Principal Investigator for the Study, said: "These headline results are very promising with a clear reduction in pain versus placebo and a good safety and tolerability profile. EMA401 offers an entirely novel approach to the treatment of PHN and could represent a valuable new option in an area where there is a clear need for new medicines. Current treatments for the condition are effective in some patients but a significant proportion either don't respond to therapy and are left with debilitating symptoms or suffer significant side effects."
PR Newswire