GENEVA--(Marketwire - September 17, 2012) - Addex Therapeutics / Addex Partner Doses First
Patient in Phase 2 Clinical Study of ADX71149 for the
Treatment of Major Depressive Disorder Patients with Anxiety Symptoms.
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Addex Therapeutics (SIX: ADXN), a
leading company pioneering allosteric modulation-based drug discovery
and
development, announced today that Janssen Research & Development, LLC, on
behalf
of Janssen Pharmaceuticals, Inc., has dosed the first patient in a
multicenter,
double-blind, Phase 2 study of ADX71149 in adults with major depressive
disorder
who are also suffering anxiety symptoms. ADX71149 is a positive
allosteric
modulator (PAM) of metabotropic glutamate receptor 2 (mGluR2), a Family C
class
of G protein coupled receptors (GPCR) that is being developed jointly by
Addex
and Janssen Pharmaceuticals, Inc. ADX71149 is also being studied in a
Phase 2
clinical trial for the treatment of positive and negative
symptoms of
schizophrenia, with top-line data expected in the fourth quarter of this
year.
"Dosing of the first patient in this Phase 2 study with ADX71149, in its
second
indication, continues our successful collaboration with, Janssen," noted
Bharatt
Chowrira, CEO of Addex Therapeutics. "Both partners are encouraged
by the
development of ADX71149 to date particularly because there is a
significant
medical and market opportunity for an innovative approach for
treating the
anxiety experienced by more than 50% of patients with depression."
The multicenter, double-blind, placebo-controlled study to evaluate the
efficacy
and overall safety and tolerability of ADX71149 (Clinicaltrials.gov
ref
NCT01582815) will be conducted as an adjunctive treatment to an
antidepressant
in 94 adults with major depressive disorder with anxiety symptoms. Oral
ADX71149
will be administered twice-daily at doses ranging from 25mg to 150mg.
Patients
will continue to take the same daily dose of their antidepressant. The
primary
endpoint of the study is the change from baseline in the Hamilton Anxiety
Rating
scale (HAM-A6) score. Secondary endpoints include change from
baseline of
several other clinician-administered rating scales designed to
assess the
severity of depression and anxiety symptoms.
The development of ADX71149 is part of a worldwide research
collaboration and
license agreement between Addex and Janssen Pharmaceuticals, Inc. to
discover,
develop and commercialize a novel mGluR2 PAM medication for the
treatment of
anxiety, schizophrenia and other undisclosed indications. Under the terms
of the
agreement, Addex is eligible for up to a total of EUR112 million in
milestone
payments based on potential development and regulatory
achievements. In
addition, Addex is eligible for low double-digit royalties on sales
of any
mGluR2 PAM medication developed under the agreement.
Addex Therapeutics (www.addextherapeutics.com) discovers and
develops an
emerging class of small molecule drugs, called allosteric modulators, 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 address receptors and other
proteins
that are recognized as attractive targets for modulation of important
diseases
with unmet medical needs. The Company's two lead products are being
investigated
in Phase 2 clinical testing: dipraglurant (ADX48621, an mGluR5
negative
allosteric modulator or NAM) is being developed by Addex to treat
Parkinson's
disease levodopa-induced dyskinesia (PD-LID); and ADX71149 (mGluR2
positive
allosteric modulator or PAM) is being developed by our partner
Janssen
Pharmaceuticals Inc. to treat schizophrenia and anxiety seen in
patients
suffering from major depressive disorder. Addex also is advancing
several
preclinical programs including: GABA-BR PAM for overactive bladder and
other
disorders; mGluR4 PAM for Parkinson's, MS, anxiety and other
diseases. In
addition, Addex is applying its proprietary discovery platform to
identify
highly selective and potent allosteric modulators of a number of both
GPCR and
non-GPCR targets that are implicated in diseases of significant unmet
medical
need.
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 mGluR2, mGluR4, mGluR5, GABABR 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, GABABR 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, GABABR 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, GABABR 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
[HUG#1641251]
