Expanded SAB will oversee development of EMA401, Company’s lead program for treating chronic pain.

Melbourne, Australia – Spinifex Pharmaceuticals, a pain drug development company,  today  announces  that  three  internationally  acclaimed  scientists  in chronic pain research have joined the Company’s Scientific Advisory Board (SAB). Their core research areas include understanding the basis for pain progressing from acute to chronic, peripheral neuropathy, diabetic neuropathy and improving clinical trials of pain treatments. In addition, Dr Declan Doogan will transition to the SAB having formerly been Chairman of Spinifex’s Board.

These new members will help guide the development of Spinifex’s lead program EMA401, a novel angiotensin II type 2 (AT2) receptor antagonist being developed as a potential first-in-class oral treatment for chronic pain without CNS side effects. The positive results of Spinifex’s Phase 2  clinical trial  of EMA401 in postherpetic neuralgia (PHN) were recently published in The Lancet (1). PHN is a painful condition that develops in some patients following herpes zoster (shingles) and where existing therapy does not relieve pain in all individuals.

Spinifex is planning a further Phase 2 study with EMA401 in PHN, and investigating it in neuropathic and inflammatory pain conditions such as osteoarthritis, chemotherapy induced neuropathy and peripheral diabetic neuropathy. The Company also intends to conduct further pre-clinical research on AT2  receptor antagonists in pain, including the company’s follow on candidate program.

The new SAB members are as follows:

Dr Thomas Schnitzer

Thomas is Professor of Internal Medicine/Rheumatology and Physical Medicine and Rehabilitation at Northwestern University Feinberg School of Medicine, Chicago, Illinois. He founded and directed the Office of Clinical Research and was assistant dean for clinical research at the medical school. Thomas has a long-standing interest in chronic musculoskeletal pain, understanding how pain progresses from acute to chronic and the development of new therapeutic approaches to pain management. He has worked closely with numerous pharmaceutical and biotechnology companies providing guidance on the design and conduct of clinical studies of novel drugs. He has most recently been involved in exploring the role of brain pathways in the development and maintenance of chronic pain. He is a Master of the American College of Rheumatology, served on the editorial board of numerous journals, and has published over 150 peer-reviewed publications. He has also contributed to the Cecil Textbook of Medicine, an authoritative textbook used in the study of medicine.

Dr Roy Freeman

Roy is Professor of Neurology at the Harvard Medical School and director of the Center  for  Autonomic  and  Peripheral  Nerve  Disorders  in  the  Department  of Neurology at Beth Israel Deaconess Medical Center in Boston, Massachusetts. His research and clinical interests are the physiology and pathophysiology of the small nerve fibers and the autonomic nervous system. His research encompasses the neurological complications of diabetes; neuropathic pain; the autonomic complications of Parkinson’s disease and multiple system atrophy; and the diagnosis and treatment of autonomic and peripheral nervous system disorders. He has a special interest in clinical trial design in neuropathic pain in diabetic peripheral neuropathy and other peripheral nerve disorders. He has been principal investigator  on  many  neuropathic  pain  clinical  trials.  He  is  the  principal investigator on  National Institutes of  Health-funded studies on  the pathophysiology  of  orthostatic  intolerance,  autoimmune  autonomic ganglionopathy,  and  hypoglycemia  and  the  autonomic  nervous  system.  Dr Freeman is also chairman of the World Federation of Neurology research group on the autonomic nervous system. Dr Freeman is Editor of Autonomic Neuroscience: Basic and Clinical and on the editorial board of The Clinical Journal of Pain and Clinical Autonomic Research.

Dr Robert Dworkin

Robert is Professor of Anesthesiology, Neurology, Oncology, and Psychiatry, Professor of Neurology in the Center for Human Experimental Therapeutics, and Director  of  the  Anesthesiology Clinical  Research  Center  at  the  University  of Rochester School of Medicine and Dentistry. He is Director of the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION), a public-private partnership with the US Food and Drug Administration (FDA). Robert’s current research focuses primarily on examining the relationships between study methodologic features and study outcomes in acute  and  chronic  pain  trials,  as  well  as  comparing  the  responsiveness  to treatment effects of different primary and secondary outcome measures. The overall objective of this work, which is being conducted under the auspices of ACTTION, is to improve the efficiency and informativeness of clinical trials of pain treatments and to provide an evidence-based approach to analgesic clinical trial design. He  is  Co-chair of  the  Initiative on  Methods, Measurement, and  Pain Assessment in Clinical Trials (IMMPACT); a member of the US Centers for Disease Control and Prevention (CDC) Zoster Working Group; and a Special Government Employee of the FDA Center for Drug Evaluation and Research. He has been a principal investigator for numerous clinical trials of analgesic treatments. Robert is an Associate Editor of Pain and sits on the editorial boards of Journal of Pain and Current Pain and Headache Reports. Robert received the American Pain Society’s Wilbert E Fordyce Clinical Investigator Award in 2005, the Eastern Pain Association’s John J Bonica Award in 2011, and the American Pain Society’s John and Emma Bonica Public Service Award in 2014.

Dr Declan Doogan

Declan joined the Spinifex Board in 2011 and formerly served as Chairman. He holds a number of Board positions in pharma companies and has recently stepped down as CMO of Amarin Corporation. Declan was Senior Vice President and Head of Worldwide Development at Pfizer Global Research & Development having held a number of senior positions in Pfizer in the US, the UK and Japan. Declan joined Pfizer in  1982, where  he  initially led  the  sertraline HCl  clinical  development program). Declan received his medical degree from Glasgow University in 1975. He is a Fellow of the Royal College of Physicians of Glasgow and the Faculty of Pharmaceutical Medicine in the UK.


Spinifex’s CEO Tom McCarthy said: “The addition of these three highly distinguished scientists in their respective areas of chronic pain and Declan joining the SAB reflects Spinifex’s ambition to advance our novel pain candidate EMA401. EMA401 has shown promise in PHN and we look forward to investigating it for other chronic pain indications that are currently poorly treated. We believe these new members will add to our already strong SAB and provide additional guidance to Spinifex as we progress our clinical programs for EMA401 and pursue its global development.”

(1) EMA401, an orally administered highly selective angiotensin II type 2 receptor antagonist, as a novel treatment for postherpetic neuralgia: a randomised, double-blind, placebo-controlled phase 2 clinical trial, Rice, A.S.C. et al. (2014) The Lancet. 383 (9929), 1637-1647.

For more information please contact:

Dr Tom McCarthy
CEO Spinifex Pharmaceuticals
Tel: +1 203 989 2100
Email: info@spinifexpharma.com

Chris Gardner/Sita Shah
Citigate Dewe Rogerson
Tel: +44 (0) 20 7638 9571
Email: sita.shah@citigatedr.co.uk


Spinifex Pharmaceuticals

Spinifex Pharmaceuticals is an Australian-US biotechnology company developing new drug candidates for the treatment and management of pain. Established in 2005 and based in Stamford, Connecticut and Melbourne, Australia, Spinifex has applied its world-class drug development capabilities to advance product candidates. Its lead product EMA401 is under development as a potential first-in-class oral treatment for chronic pain without CNS side effects. Spinifex’s Phase 2 program for EMA401 includes clinical trials in a number of chronic pain conditions. Spinifex’s investors are Novo A/S, Canaan Partners, GBS Venture Partners, Brandon Capital Partners, Uniseed and UniQuest.


EMA401 and the AT2 receptor antagonist program

EMA401 is an angiotensin II type 2 (AT2) receptor antagonist. The discovery that AT2   receptor  antagonists  offer  an  innovative  approach  to  the  treatment  of neuropathic and inflammatory pain was originally made by Professor Maree Smith at The University of Queensland. Having acquired the technology, Spinifex has conducted a comprehensive pre-clinical and early clinical development program on EMA401. In addition to positive Phase 2 results published in The Lancet, EMA401 has shown efficacy in a number of relevant pre-clinical models and good human safety and pharmacokinetics in Phase 1 studies. Spinifex’s clinical program for EMA401 includes an ongoing Phase 2 study in the treatment of pain in patients with cancer chemotherapy. Spinifex continues to conduct research into the role of the AT2  receptor in nociceptive, inflammatory and neuropathic pain states and these fundamental studies support not only the EMA401 clinical program but also Spinifex’s ongoing AT2 receptor antagonist drug discovery program.