Spinifex Pharmaceuticals, an Australian pain drug development company, has reported that the Phase II trial of EMA401, for the treatment of postherpetic neuralgia (PHN), met its primary endpoint.
The primary endpoint of the placebo-controlled randomised trial was the reduction in mean daily pain score versus a placebo over the last week of 28 days of treatment.
Existing therapies for PHN, which can develop following herpes zoster (shingles), do not relieve pain in all patients.
The study principal investigator Dr Milton Raff said the headline results show clear pain reduction 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,” Dr Raff said.
“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.”
According to study results, a statistically significant and clinically meaningful reduction in mean pain intensity from baseline to week four for subjects on active treatment was observed.
The study also met its secondary endpoint by demonstrating a significantly greater proportion of patients on active treatment reported more than 30% reduction in pain.
No serious treatment-related adverse events were observed and EMA401 was generally safe and well tolerated in the study.
Spinifex Pharmaceuticals CEO Tom McCarthy said; “We look forward to advancing EMA401 further in PHN and other neuropathic pain indications including cancer chemotherapy induced neuropathic pain and painful diabetic neuropathy.”