Addex Reports ADX71441 Reduces Alcohol Intake in a Preclinical Model of Chronic Alcohol Dependence
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Addex Reports ADX71441 Reduces Alcohol Intake in a Preclinical Model of Chronic
Alcohol Dependence
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* Data reinforces broad therapeutic potential of ADX71441, an oral GABAB
receptor Positive Allosteric Modulator
* Recent approval of Clinical Trial Application (CTA) to initiate a Phase 1,
first-in-man, clinical study
* Phase 1 initiation on track by July 2013
Geneva, Switzerland, 30 April 2013 - (SIX:ADXN), a leading company pioneering
allosteric modulation-based drug discovery and development, announced today
positive preclinical data for its GABAB receptor positive allosteric modulator
(PAM) oral small molecule in a validated rodent model of chronic alcohol
dependence (i.e. alcoholism). The Addex' clinical candidate, ADX71441,
demonstrated robust and dose-dependent suppression of alcohol intake in animals
lasting 24 hours.
"These data support and expand those obtained previously in a mouse model of
binge alcohol drinking with this molecule. Taken together, they offer strong
evidence that ADX71441 can be used as a treatment of binge drinking and chronic
alcohol dependence," said Professor Klaus Miczek at Tufts University (USA) in
whose laboratory the study was performed.
ADX71441 is an oral small molecule, with potential for once daily dosing, which
selectively activates GABAB receptor. The compound was evaluated in an
intermittent access to alcohol model of chronic alcohol dependence in mice.
This procedure generates excessive voluntary alcohol drinking after animals are
given 24-hour access to alcohol concomitant to water every other day. In
animals with a history of 4 weeks of excessive drinking, oral ADX71441 (3,
10, 17 mg/kg), administered acutely, resulted in a dose-dependent suppression of
alcohol intake, achieving 70% reductions at the higher doses (17 mg/kg) in
comparison to vehicle treatment. Significant reductions in alcohol consumption
in response to ADX71441 treatment were present for the entire 24-hour alcohol
access period. The effect of ADX71441 in this model was more robust and longer-
lasting than that seen in mice treated with naltrexone, used in the study as a
positive control. Also, the effect of ADX71441 was characterized with
remarkable behavioral specificity since water consumption was not influenced by
the treatment.
"These data again support the potential of ADX71441 in a broad range of
indications," noted Dr Graham Dixon, CSO at Addex. "We believe that a, once-a-
day, well-tolerated, efficacious oral treatment for alcoholism would represent a
major advance in the treatment of this devastating condition."
Oral small molecule GABAB receptor PAMs have broad potential in multiple
indications and Addex has previously demonstrated positive proof of concept in a
range of preclinical models including those of pain, anxiety, obsessive-
compulsive disorder and overactive bladder (OAB). Based on ADX71441 current data
package, Addex is positioning the drug candidate as a treatment for the rare
disease CMT1a, a form of peripheral neuropathy as well as for patients with
spasticity, e.g. in multiple sclerosis or spinal cord injury.
"We look forward to initiating the clinical testing for this compound," stated
Bharatt Chowrira, Ph.D., Chief Executive Officer at Addex. "We can see a huge
market opportunity for a GABAB PAM in a variety of psychiatric and neurological
conditions as well as a potential replacement therapy for baclofen. We believe
we can potentially build sustainable and valuable franchises around both
ADX71441 and dipraglurant in that both represent treatments for a wide range of
therapeutic indications. We expect to deliver top-line safety, pharmacokinetic
and biomarker data on ADX71441 by year end."
About Alcoholism
Alcoholism is a broad term for problems with alcohol, and is generally
indicative of compulsive and uncontrolled consumption of alcoholic beverages. It
is medically considered a disease, specifically an addictive illness. The World
Health Organization estimates that about 140 million people throughout the world
suffer from alcohol dependence. Patients with alcoholism suffer major changes to
the brain structure and chemistry. Excessive alcohol consumption damages almost
every organ in the body and the cumulative toxic effects can cause both medical
(cirrhosis of the liver, pancreatitis, heart disease, peptic ulcers, sexual
dysfunction) and psychiatric (epilepsy, dementia, psychosis, anxiety &
depression) problems. Treatment of alcoholism is complex with a current standard
of care typically being prescribed to patients with heavy drinking but largely
being unable to prevent them from relapsing.
About GABAB receptor Activation
Activation of gamma-aminobutyric acid subtype B (GABAB) receptor, a Family C
class of GPCR, is clinically and commercially validated by generic GABAB
receptor agonist, baclofen, which is marketed for spasticity in spinal cord
injury patients. Baclofen has also shown clinical relevance in a number of other
indications including overactive bladder, pain and is in early stage clinical
development for alcohol dependence and autism. Despite baclofen's broad clinical
validation, it is not commonly used due to multiple side effects, rapid
clearance and withdrawal syndromes. Orthosteric GABAB receptor agonists have
also shown clinical validation in gastroesophageal reflux disease (GERD). Addex'
GABAR PAMs have shown efficacy in multiple preclinical models including: OAB,
pain, osteoarthritis pain, anxiety and alcoholism.
About Addex Therapeutics
Addex Therapeutics (www.addextherapeutics.com) is a development stage company
focused on advancing innovative oral small molecules against rare diseases
utilizing its pioneering allosteric modulation-based drug discovery platform.
The Company's two lead products are being investigated in Phase 2 clinical
testing: dipraglurant (an mGlu5 negative allosteric modulator or NAM) is being
developed by Addex to treat Parkinson's disease levodopa-induced dyskinesia (PD-
LID) and rare forms of dystonia; and ADX71149 (mGlu2 positive allosteric
modulator or PAM) is being developed in collaboration with Janssen
Pharmaceuticals, Inc. to treat both schizophrenia and anxiety as seen in
patients suffering from major depressive disorder. Addex is also advancing
several preclinical programs including: GABA-BR positive allosteric modulator
(PAM) for Charcot-Marie-Tooth (type 1a) disease, spasticity in patients with
multiple sclerosis (MS), pain, overactive bladder and other disorders; and mGlu4
PAM for MS, Parkinson's disease, anxiety and other diseases. Allosteric
modulators are an emerging class of small molecule drugs which have the
potential to be more specific and confer significant therapeutic advantages over
conventional "orthosteric" small molecule or biological drugs. The Company uses
its proprietary discovery platform to target receptors and other proteins that
are recognized as essential for the therapeutic modulation of important diseases
with unmet medical needs.
Tim Dyer
Chief Financial Officer
Addex Therapeutics
+41 22 884 15 61
PR(at)addextherapeutics.com
Disclaimer: The foregoing release may contain forward-looking statements that
can be identified by terminology such as "not approvable", "continue",
"believes", "believe", "will", "remained open to exploring", "would", "could",
or similar expressions, or by express or implied discussions regarding Addex
Therapeutics, formerly known as, Addex Pharmaceuticals, its business, the
potential approval of its products by regulatory authorities, or regarding
potential future revenues from such products. Such forward-looking statements
reflect the current views of Addex Therapeutics regarding future events, future
economic performance or prospects, and, by their very nature, involve inherent
risks and uncertainties, both general and specific, whether known or unknown, or
any other factor that may materially differ from the plans, objectives,
expectations, estimates and intentions expressed or implied in such forward-
looking statements. Such may in particular cause actual results with allosteric
modulators of mGluR2, mGluR4, mGluR5, GABAB receptors or other therapeutic
targets to be materially different from any future results, performance or
achievements expressed or implied by such statements. There can be no guarantee
that allosteric modulators of mGluR2, mGluR4, mGluR5, GABAB receptors or other
therapeutics targets will be approved for sale in any market or by any
regulatory authority. Nor can there be any guarantee that allosteric modulators
of mGluR2, mGluR4, mGluR5, GABAB receptors or other therapeutic targets will
achieve any particular levels of revenue (if any) in the future. In particular,
management's expectations regarding allosteric modulators of mGluR2, mGluR4,
mGluR5, GABAB receptors or other therapeutic targets could be affected by, among
other things, unexpected actions by our partners, unexpected regulatory actions
or delays or government regulation generally; unexpected clinical trial results,
including unexpected new clinical data and unexpected additional analysis of
existing clinical data; competition in general; government, industry and general
public pricing pressures; or the company's ability to obtain or maintain patent
or other proprietary intellectual property protection. Should one or more of
these risks or uncertainties materialize, or should underlying assumptions prove
incorrect, actual results may vary materially from those anticipated, believed,
estimated or expected. Addex Therapeutics is providing the information in this
press release as of this date and does not undertake any obligation to update
any forward-looking statements contained in this press release as a result of
new information, future events or otherwise, except as may be required by
applicable laws.
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Source: Addex Therapeutics via Thomson Reuters ONE
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Datum: 30.04.2013 - 07:01 Uhr
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News-ID 254149
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