2013-03-21 17:32:57 -
Addex Therapeutics /
Addex Therapeutics Announces Presentation of Dipraglurant Phase 2a Study Results
at the 2013 Annual Meeting of the American Academy of Neurology (AAN)
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The issuer is solely responsible for the content of this announcement.
$1 MM grant by The Michael J. Fox Foundation to be used to help fund further
human clinical testing of dipraglurant for the treatment of Parkinson's disease
levodopa-induced dyskinesia
Geneva, Switzerland, 21 March 2013 - Addex Therapeutics (SIX: ADXN), a leading
company pioneering allosteric modulation-based drug discovery and development
announced today that François Tison, M.D.-Ph.D., Professor at the University of
Bordeaux, on behalf of the ADX48621-201 Study Group, presented the positive data
obtained from a Phase 2a
proof-of-concept trial of dipraglurant (ADX48621) in
Parkinson's patients with levodopa-induced dyskinesia (PD-LID) in an oral
presentation at the AAN conference on 20th March 2013. The recent $1,000,000
grant by The Michael J. Fox Foundation for Parkinson's Research will be used to
help fund continued human clinical testing of dipraglurant for the treatment of
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.
"We believe the successful completion of the Phase 2a study showed significant
promise that dipraglurant has the potential to change the way these patients are
treated as well as their quality of life," said Graham Dixon, Ph.D., Chief
Scientific Officer of Addex Therapeutics. "The clinical studies that we plan to
complete in the coming months, supported in part by the grant from The
Foundation, are critical to our continued advancement of this important approach
for the treatment of PD-LID."
Dipraglurant is an oral, small molecule allosteric modulator that inhibits
selectively the metabotropic glutamate receptor 5 (mGlu5), a Class C G-Protein
Coupled Receptor (GPCR). The Phase 2a trial was a randomised, double-blind,
placebo-controlled study in 76 patients with moderate to severe levodopa-induced
dyskinesia conducted at 25 sites in Europe and the United States. In the
presentation at the AAN conference, Professor Tison reported that the study met
the primary objectives of safety and tolerability at both 50 and 100mg doses;
supporting further clinical testing in this patient population. In addition,
dipraglurant demonstrated positive anti-dyskinetic effect measured by observer
evaluated mAIMS, patient reported diary data and patient and clinician global
impression of change scales. Further, there was no negative effect on
Parkinsonism and the data suggested that dipraglurant provided a beneficial
effect on motor fluctuation. Addex has previously reported top-line results
from this study last year. The Phase 2a study was supported by a $900,000 grant
from The Michael J. Fox Foundation for Parkinson's Research.
"We continue to be engaged in partnering discussions with a number of global
players who we believe have the expertise and capability to fully exploit
dipraglurant and expect to have a deal completed sometime this year," said
Bharatt Chowrira, Ph.D., Chief Executive Officer of Addex Therapeutic. "While we
continue to advance this compound for PD-LID we will also initiate parallel
clinical efforts for a rare form of dystonia. We expect to initiate a Phase 2
study in dystonia and report data by the end of 2013. Completion of the PD-LID
clinical work as well as the dystonia study will bring significant value to our
dipraglurant franchise."
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@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.
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