New Data on EMA401 in Model of Diabetic Neuropathy Presented at 21st Annual NEURODIAB Meeting
MELBOURNE, Australia, September 12, 2011 /PRNewswire/ –
EMA401 Shown to Improve Nerve and Neurovascular Function
Spinifex Pharmaceuticals, an Australian pain drug development company,
today announces the presentation of new data from a study of EMA401 in a
model of diabetic neuropathy. EMA401 is an angiotensin II type 2 (AT2)
receptor antagonist currently in clinical development for a number of
neuropathic pain indications.
The new data were presented at the 21st annual meeting of the Diabetic
Neuropathy Study Group of the European Association for the Study of
Diabetes, NEURODIAB, on the 11th September by Professors Norman Cameron and
Mary Cotter of the University of Aberdeen.
Diabetic neuropathy is a side effect of diabetes that is characterized
by the peripheral nerves not functioning properly. Patients present with
symptoms that include pain but can also include sensory loss and reduced
reflex. Diminished nerve conduction velocities resulting from damage to the
peripheral nervous system have also been linked to other serious side
effects of diabetes such as ulcers of the feet and legs which can ultimately
lead to amputation.
In the new study, initiated by Spinifex Pharmaceuticals, EMA401 was
shown to correct motor and sensory nerve conduction velocity (NCV) in an
established animal model of diabetes. EMA401 also reduced pain and heat
sensitivity and corrected sciatic nerve nutritive blood flow. EMA401 was
effective at a dose of 1 mg/kg/day and no CNS side effects were observed,
consistent with earlier studies at this and higher doses.
Spinifex Pharmaceuticals CEO Tom McCarthy said: “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neuropathic and inflammatory pain was originally made by Professor Maree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 and we have good earlier data on the
impact of EMA401 on neuropathic pain in pre-clinical models. This new study
we initiated with Professors Cameron and Cotter not only reinforces our
earlier data on the impact of EMA401 on neuropathic pain but also confirms
our hypothesis that EMA401 may treat the underlying nerve conduction
velocity deficits that are the hallmark of diabetic neuropathy. This expands
the range of potential indications for the compound and, importantly,
provides a new therapeutic target for what is a particularly devastating
form of neuropathy.”
Professor Norman Cameron said: “Inhibition of the renin-angiotensin
system can reduce the development of diabetic complications including
neuropathy but most attention has focussed on AT1 receptor-mediated
mechanisms. This is the first study of the effect of an AT2 receptor
antagonist on nerve function in an appropriate diabetes model. In showing
EMA401 corrects aspects of neurovascular dysfunction the data suggests the
AT2 receptor is a valuable new potential therapeutic target in diabetic
Spinifex acquired the initial technology underpinning EMA401 from The
University of Queensland and has conducted a comprehensive pre-clinical and
early clinical development program. EMA401 has shown efficacy in a number of
relevant models, good human safety and pharmacokinetics in Phase 1 studies
and the first of three Phase 2 clinical trials will be initiated shortly.
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.
The program from the NEURODIAB 2011 meeting can be found by following
the links from http://www.neurodiab-easd.org .
Spinifex Pharmaceuticals is an Australian biotechnology company
developing new drug candidates for the treatment and management of pain.
Established in 2005 and based in Melbourne, 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 neuropathic pain and related symptoms without CNS side
effects. Spinifex is conducting Phase 2 clinical trials with EMA401 in a
number of neuropathic pain conditions. Spinifex investors are GBS Venture
Partners, Brandon Capital Partners, Uniseed and UniQuest.
For more information please contact: Company Dr Tom McCarthy CEO Spinifex Pharmaceuticals Tel: +61(0)3-9938-1205 Email: email@example.com Media Chris Gardner/Nina Enegren Citigate Dewe Rogerson Tel: +44(0)20-7638-9571 Email: firstname.lastname@example.org
SOURCE Spinifex Pharmaceuticals