PLAN-LES-OUATES GENEVA, SWITZERLAND--(Marketwire - June 05, 2012) -
Addex Therapeutics /
Addex Partner to Initiate Phase 2 Clinical Trial of ADX71149 for the
of Major Depressive Disorder with Anxiety Symptoms
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Addex Therapeutics Ltd (SIX: ADXN), a leading
company pioneering allosteric modulation-based drug discovery and
announced today that Janssen Research & Development, LLC, on behalf of
Pharmaceuticals, Inc., is initiating a multicenter, double-blind, Phase 2
of ADX71149 in adults with major depressive disorder who are also
anxiety symptoms. ADX71149 is a positive allosteric modulator
metabotropic glutamate receptor 2 (mGluR2), a Family C class of G
Coupled Receptor (GPCR) that is being jointly developed by Addex and
Pharmaceuticals, Inc., formerly known as Ortho-McNeil-Janssen
Inc. ADX71149 is also being studied in a Phase 2 clinical trial
treatment of positive and negative symptoms of schizophrenia.
"The initiation of this second Phase 2 study is an indication of the
for ADX71149 to treat more than one psychiatric disorder. We are
our partner Janssen's continued commitment towards advancing
multiple indications," noted Bharatt Chowrira, CEO of Addex Therapeutics.
has been little innovation recently in the way that patients with
depression and anxiety are treated. This provides a significant
market opportunity for an innovative approach such as ADX71149 for treating
important psychiatric condition."
The multicenter, double-blind, placebo-controlled study to evaluate the
and overall safety and tolerability of ADX71149 (Clinicaltrials.gov
NCT01582815) will be conducted as an adjunctive treatment to an
in 94 adults with major depressive disorder with anxiety symptoms. Oral
will be administered twice-daily at doses ranging from 25mg to 150mg.
will continue to take the same daily dose of their antidepressant. The
endpoint of the study is the change from baseline in the Hamilton Anxiety
scale (HAM-A6) score. Secondary endpoints include change from
several other clinician-administered rating scales designed to
severity of depression and anxiety symptoms.
The development of ADX71149 is part of a worldwide research
license agreement between Addex and Janssen Pharmaceuticals, Inc. to
develop and commercialize a novel mGluR2 PAM medication for the
anxiety, schizophrenia and other undisclosed indications. Under the terms
agreement, Addex is eligible for up to a total of EUR112 million in
payments based on potential development and regulatory
addition, Addex is eligible for low double-digit royalties on sales
mGluR2 PAM medication developed under the agreement.
Addex Therapeutics (www.addextherapeutics.com) discovers and
emerging class of small molecule drugs, called allosteric modulators, which
the potential to be more specific and confer significant therapeutic
over conventional "orthosteric" small molecule or biological drugs. The
uses its proprietary discovery platform to address receptors and other
that are recognized as attractive targets for modulation of important
with unmet medical needs. The Company's two lead products are being
in Phase 2 clinical testing: dipraglurant (ADX48621, an mGluR5
allosteric modulator or NAM) is being developed by Addex to treat
disease levodopa-induced dyskinesia (PD-LID); and ADX71149 (mGluR2
allosteric modulator or PAM) is being developed by our partner
Pharmaceuticals, Inc. to treat schizophrenia, anxiety and other
indications. Addex also is advancing several preclinical programs
GABA-BR PAM for overactive bladder, pain and other disorders; mGluR4
Parkinson's, anxiety and other diseases; GLP1R PAM for type 2
mGluR2 NAM for treating Alzheimer's disease and depression. In addition,
has discovery programs to identify allosteric modulators of: receptor
kinase (RTK) superfamily, including TrkB PAM for treating
diseases (e.g. Alzheimer's, Parkinson's and Huntington's diseases);
receptor superfamily, including TNFR1 NAM for inflammation (e.g.
arthritis) and other diseases.
Disclaimer: The foregoing release may contain forward-looking statements
can be identified by terminology such as "not approvable",
"believes", "believe", "will", "remained open to exploring", "would",
or similar expressions, or by express or implied discussions regarding
Therapeutics, formerly known as, Addex Pharmaceuticals, its
potential approval of its products by regulatory authorities, or
potential future revenues from such products. Such forward-looking
reflect the current views of Addex Therapeutics regarding future events,
economic performance or prospects, and, by their very nature, involve
risks and uncertainties, both general and specific, whether known or
and/or any other factor that may materially differ from the plans,
expectations, estimates and intentions expressed or implied in such
forward-looking statements. Such may in particular cause actual results
modulators of mGluR2, mGluR4, mGluR5, mGluR7, GABABR, GLP1R, TNFR1,
other therapeutic targets to be materially different from any future
performance or achievements expressed or implied by such statements.
be no guarantee that allosteric modulators of mGluR2, mGluR4, mGluR5,
GABABR, GLP1R, TNFR1, TrkB or other therapeutics targets will be
sale in any market or by any regulatory authority. Nor can there
guarantee that allosteric modulators of mGluR2, mGluR4, mGluR5, mGluR7,
GLP1R, TNFR1, , TrkB or other therapeutic targets will achieve any
levels of revenue (if any) in the future. In particular,
expectations regarding allosteric modulators of mGluR2, mGluR4, mGluR5,
GABABR, GLP1R, TNFR1 , TrkB or other therapeutic targets could be
among other things, unexpected actions by our partners, unexpected
actions or delays or government regulation generally; unexpected clinical
results, including unexpected new clinical data and unexpected
analysis of existing clinical data; competition in general; government,
and general public pricing pressures; the company's ability to
maintain patent or other proprietary intellectual property protection.
one or more of these risks or uncertainties materialize, or should
assumptions prove incorrect, actual results may vary materially from
anticipated, believed, estimated or expected. Addex Therapeutics is
the information in this press release as of this date and does not
obligation to update any forward-looking statements contained in this
release as a result of new information, future events or otherwise,
may be required by applicable laws.
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