NEW YORK, NY and GENEVA--(Marketwire - March 19, 2013) - Addex Therapeutics / Addex
Therapeutics Awarded $1 MM Grant from The Michael J. Fox Foundation for
Parkinson's Research.
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The issuer is solely responsible for the content of this announcement.
Grant to be used to help fund further human clinical testing of
dipraglurant for
the treatment of Parkinson's disease levodopa-induced dyskinesia
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: @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.
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.
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Source: Addex Therapeutics via Thomson Reuters ONE
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