Spinifex secures AU$6.25 million in expanded Series B funding

Spinifex Pharmaceuticals, an Australian pain drug development company, today announced it has secured a further AU$6.25 million of venture capital investment from GBS Venture Partners Limited, Brandon Capital Partners Pty Limited, Uniseed Management Pty Limited and UniQuest Pty Limited to fund the development of its pain management drug, EMA401.

This expanded Series B funding builds on a previously announced AU$12 million investment from the same syndicate and will be used in part to expand the Phase 2 clinical trial program for EMA401 to a further two indications, specifically;

• The treatment of pain and hypersensitivity in peripheral nerve injury patients.
• The treatment of pain and hypersensitivity in cancer chemotherapy patients.

These new clinical trials are a translation into clinical research of the results from Spinifex's ongoing collaboration with Prof. Praveen Anand (Professor of Clinical Neurology at Imperial College London's Hammersmith Hospital) and his research laboratory.

The studies will run alongside a soon to be initiated Phase 2 clinical trial of EMA401 in postherpetic neuralgia, a painful condition that develops in some patients following herpes zoster (shingles) and where existing therapy does not relieve pain in all individuals.

EMA401 is an angiotensin II type 2 (AT₂) receptor antagonist. The discovery that this class of molecules offers an innovative approach to the treatment of neuropathic and inflammatory pain was originally made by Professor Maree Smith at the University of Queensland. Having licensed the technology, Spinifex has conducted a comprehensive pre-clinical and early clinical development program. EMA401 has shown efficacy in a number of relevant models and good human safety and pharmacokinetics in Phase 1 studies.

Spinifex Pharmaceuticals CEO Tom McCarthy said: "We appreciate the ongoing support of our investors. Their further investment allows us to expand the EMA401 Phase 2 clinical program and also gives us additional flexibility as we plan the further development of this asset. Building on Prof. Smith's original discovery, Prof. Anand's studies on the AT₂ receptor in tissue samples collected from patients with different neurological conditions, have demonstrated a clear rationale for the use of AT₂ receptor antagonists in a number of painful conditions and we have used this data to select these important additional clinical indications."

Prof. Anand commented: "Based on our human tissue laboratory data, the AT₂ receptor is a very promising novel target in pain research and EMA401 has demonstrated excellent results in our studies. We are excited to expand our collaboration with Spinifex into clinical research. Our innovative study designs incorporate new functional pain biomarkers and correlative histological assessments. In addition, the selection of the clinical indications was informed by a broad assessment of AT₂ receptor localisation in somatic and visceral pain pathways, and functional studies in isolated human neurones to better define clinical doses."

Prof. Chas Bountra, Chair of Spinifex's Scientific Advisory Board said: "The discovery and the development of new pain medicines desperately needs innovative approaches in order to address the significant unmet medical need. Prof. Anand's approach of conducting fundamental pharmacology studies in human tissue samples and then translating the results into clinical proof of concept studies represents a paradigm shift in how new pain medicines are discovered. Using this approach, Prof. Anand moved the development of a number of assets forward during my time as Vice President and Head of Biology at GSK's Neurology and Gastrointestinal Diseases CEDD, including most recently their novel p38 mitogen-activated protein kinase (MAPK) inhibitor dilmapimod, and we will use the same approach in our studies with EMA401."

Spinifex's clinical program for EMA401 is initially focused on neuropathic pain, an area of high unmet medical need. 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. As a result, EMA401 is being developed as a potential first-in-class oral treatment for neuropathic pain and related symptoms without central nervous system side effects.