Spinifex Pharmaceuticals focuses on the clinical development of EMA401 for the treatment of chronic pain.
Spinifex's Clinical Development of EMA401, a Highly Selective AT2 Receptor Antagonist: Clinical Proof of Concept Efficacy Established
Lead Programs in Neuropathic Pain
Neuropathic pain is defined by the Neuropathic Pain Special Interest Group of the International Association for the Study of Pain (NeuPSIG) as "pain arising as direct consequence of a lesion or disease affecting the somatosensory system". The causes of neuropathic pain are diverse and include diabetes (diabetic neuropathy), cancer or its treatment with therapy agents (eg. chemotherapy induced neuropathy), viruses (eg. post herpetic neuralgia) and nerve trauma (peripheral nerve injury induced neuropathy). The market for neuropathic pain treatments is expected to continue to increase and is projected to reach US$3.6 billion by 2020(1). Despite this growth, current therapy needs to be improved as a significant proportion of neuropathic pain patients don’t respond to current therapy and these treatments have dose-limiting side effects.
Target Product Profile for EMA401 in Neuropathic Pain
Recognising the limitations in current treatments for neuropathic pain, EMA401 is being developed as a potential first-in-class oral treatment for neuropathic pain and related symptoms without central nervous system side effects.
Phase 2 Clinical Development of EMA401
The initial Phase 2 clinical trial of EMA401 was in post herpetic neuralgia (PHN) patients. PHN is a painful condition that develops in some patients following herpes zoster (shingles). 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 for patients with post-baseline data, 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 also reported a more than 30% reduction in mean pain intensity score compared to baseline (i.e. responder rate) (EMA401: 57.6%; Placebo: 35.2%; p = 0.0023), meeting a key secondary endpoint. EMA401 was generally safe and well tolerated with no serious treatment related adverse events reported. Further information about this clinical trial can be found at the ANZCTR website.
In addition to this clinical trial in PHN patients, Spinifex’s clinical program for EMA401 includes a Phase 2 study in the treatment of pain in cancer chemotherapy patients. Patient recruitment is ongoing. Further information about this clinical trial can be found at the ANZCTR website.
(1) Nature Reviews Drug Discovery Feb 2012, The Neuropathic Pain Market, vol. 11, pp. 101-2.
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