Addex Pharmaceuticals SA : Addex Partner to Initiate Phase 2 Clinical Trial of ADX71149 for the Treatment of Major Depressive Disorder with Anxiety Symptoms
06/05/2012| 01:58am US/Eastern
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Geneva, Switzerland, 5 June 2012 - Addex Therapeutics Ltd
(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., is initiating 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
Receptor (GPCR) that is being jointly developed by Addex
and Janssen Pharmaceuticals, Inc., formerly known as
Ortho-McNeil-Janssen Pharmaceuticals, Inc. ADX71149 is also
being studied in a Phase 2 clinical trial for the treatment
of positive and negative symptoms of schizophrenia.
"The initiation of this second Phase 2 study is an
indication of the potential for ADX71149 to treat more than
one psychiatric disorder. We are delighted by our
partner Janssen's continued commitment towards advancing
ADX71149 in multiple indications," noted Bharatt Chowrira,
CEO of Addex Therapeutics. "There has been little
innovation recently in the way that patients with both
depression and anxiety are treated. This provides a
significant medical and market opportunity for an
innovative approach such as ADX71149 for treating this
important psychiatric condition."
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 €112 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, anxiety and other undisclosed indications.
Addex also is advancing several preclinical programs
including: GABA-BR PAM for overactive bladder, pain and
other disorders; mGluR4 PAM for Parkinson's, anxiety
and other diseases; GLP1R PAM for type 2 diabetes; and
mGluR2 NAM for treating Alzheimer's disease and
depression. In addition, Addex has discovery programs to
identify allosteric modulators of: receptor tyrosine kinase
(RTK) superfamily, including TrkB PAM for treating
neurodegenerative diseases (e.g. Alzheimer's, Parkinson's
and Huntington's diseases); and TNF receptor superfamily,
including TNFR1 NAM for inflammation (e.g. rheumatoid
arthritis) and other diseases.
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, mGluR7, GABABR,
GLP1R, TNFR1, TrkB 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, mGluR7, GABABR, GLP1R, TNFR1, TrkB
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, mGluR7, GABABR, GLP1R, TNFR1, , TrkB 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, mGluR7, GABABR,
GLP1R, TNFR1 , TrkB 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.