Addex Therapeutics Awarded $1 MM Grant from The Michael J. Fox Foundation for Parkinson's Research
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Addex Therapeutics Awarded $1 MM Grant from The Michael J. Fox Foundation for
Parkinson's Research
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Grant to be used to help fund further human clinical testing of dipraglurant for
the treatment of Parkinson's disease levodopa-induced dyskinesia
New York, NY and Geneva, Switzerland, 19 March 2013 - Addex Therapeutics (SIX:
ADXN), a leading company pioneering allosteric modulation-based drug discovery
and development, and The Michael J. Fox Foundation for Parkinson's Research
announced today that the Foundation awarded a $1,000,000 grant to Addex to help
fund continued human clinical testing of dipraglurant for the treatment of
Parkinson's disease levodopa-induced dyskinesia (PD-LID). One-third of people
with PD develop dyskinesia within four to six years of beginning levodopa
treatment; this increases to approximately 90 percent after nine or more years.
Patients with Parkinson's disease (PD) can live 10-20 years after diagnosis;
however, PD-LID is a leading cause of disability in this growing patient
population.
"Dyskinesia is a top priority for our Foundation because of its significant
negative impact on patients' quality of life," said Todd Sherer, Ph.D., Chief
Executive Officer of The Michael J. Fox Foundation. "Candidates such as
dipraglurant and other innovative therapies in development offer the possibility
of improved quality of life through better symptomatic treatment of Parkinson's.
Dipraglurant targets a molecular mechanism that our Foundation has been
investing in since 2005 and we are pleased to take part in its continued
progress to the clinic. We are enthusiastic about funding this work and hopeful
that it may offer patients relief from a longstanding issue with the treatment
of their disease."
Dyskinesias are the uncontrollable and disruptive movements that are caused by
long-term use of levodopa (Sinemet), a dopamine replacement therapy and the
gold-standard treatment for Parkinson's disease. There is no FDA-approved
treatment for dyskinesia. Existing treatment options are limited and
insufficient to address patients' medical needs. Patients are faced with a lose-
lose situation: Take as much levodopa as needed to manage symptoms, and cope
with dyskinesia; or take less medicine in an effort to delay or prevent
dyskinesia, and cope with symptoms. The Michael J. Fox Foundation has invested
more than $26 million in dyskinesia-targeted research to date, including support
for a successful Phase 2a trial of dipraglurant completed by Addex in 2012.
"We are extremely pleased to receive this grant from The Michael J. Fox
Foundation supporting the further development of dipraglurant," said Bharatt
Chowrira, Ph.D., Chief Executive Officer of Addex Therapeutics. "We believe the
successful completion of the Phase 2a study offers some promise that
dipraglurant has the potential to significantly change both the way patients are
treated as well as their quality of life. The work we will be able to pursue
with this grant is critical to our continued advancement of this important
approach to the treatment of PD-LID. Ultimately, we hope to see dipraglurant
become the first drug to alleviate all PD-LID symptoms."
Dipraglurant is an oral, small molecule allosteric modulator that inhibits
selectively the metabotropic glutamate receptor 5 (mGluR5), a Class C G-Protein
Coupled Receptor (GPCR). Dipraglurant holds potential to be used in combination
with levodopa or dopamine agonists, or as a standalone treatment for PD-LID, PD-
related motor symptoms, dystonia, non-motor symptoms of PD and other movement
disorders. Data from a Phase 2a showed that dipraglurant met the primary
objective of the study by exhibiting a good safety and tolerability profile.
Dipraglurant also demonstrated a statistically significant reduction in LID
severity with both 50 and 100 mg doses. Dipraglurant appears to reduce dystonia
severity in addition to chorea, the two major LID components. In a double-blind,
placebo-controlled study conducted in the US and Europe, the primary objective
was to demonstrate safety and tolerability in PD-LID patients. In addition, the
trial was designed to evaluate exploratory efficacy as a secondary objective.
Efficacy was measured using the modified Abnormal Involuntary Movement Scale
(mAIMS), patient diaries documenting "off-time" (impaired voluntary movement),
"on-time" (with or without dyskinesia) and sleep. The trial was supported by a
grant from The Michael J. Fox Foundation for Parkinson's Research.
About The Michael J. Fox Foundation for Parkinson's Research
As the world's largest private funder of Parkinson's research, The Michael J.
Fox Foundation is dedicated to accelerating a cure for Parkinson's disease and
improved therapies for those living with the condition today. The Foundation
pursues its goals through an aggressively funded, highly targeted research
program coupled with active global engagement of scientists, Parkinson's
patients, business leaders, clinical trial participants, donors and volunteers.
In addition to funding more than $300 million in research to date, the
Foundation has fundamentally altered the trajectory of progress toward a cure.
Operating at the hub of worldwide Parkinson's research, the Foundation forges
groundbreaking collaborations with industry leaders, academic scientists and
government research funders; increases the flow of participants into Parkinson's
disease clinical trials with its online tool, Fox Trial Finder; promotes
Parkinson's awareness through high-profile advocacy, events and outreach; and
coordinates the grassroots involvement of thousands of Team Fox members around
the world.
For more information, visit us at:
Web site: michaeljfox.org
Facebook: facebook.com/michaeljfoxfoundation
LinkedIn: bit.ly/mjffPDOR
Twitter: (at)MichaelJFoxOrg
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 (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,
and/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 mGlu2, mGlu4, mGlu5, GABA-BR 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 mGlu2, mGlu4, mGlu5, GABA-BR 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 mGlu2, mGlu4,
mGlu5, GABA-BR 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 mGlu2, mGlu4, mGlu5, GABA-BR 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; 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.
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Addex Therapeutics via Thomson Reuters ONE
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Datum: 19.03.2013 - 07:00 Uhr
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News-ID 240585
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