EMA401 Development

Spinifex's Clinical Development of EMA401, a Highly Selective AT₂ Receptor Antagonist

Focus on 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$6.2 billion by 2017. 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

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 of EMA401 is in post herpetic neuralgia (PHN) patients. PHN is a painful condition that develops in some patients following herpes zoster (shingles). Further information about this clinical trial can be found at the ANZCTR website. This trial is actively recruiting patients.

In addition to this clinical trial in PHN patients, Spinifex’s clinical program for EMA401 will include studies in other neuropathic pain indications including the treatment of pain and hypersensitivity in peripheral nerve injury patients, as well as pain and hypersensitivity in cancer chemotherapy patients. Protocols for these two further studies are being developed.