Addex Partner to Initiate Phase 2 Clinical Trial of ADX71149 for the Treatment of Major Depressive Disorder with Anxiety Symptoms
(Thomson Reuters ONE) -
Addex Therapeutics /
Addex Partner to Initiate Phase 2 Clinical Trial of ADX71149 for the Treatment
of Major Depressive Disorder with Anxiety Symptoms
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The issuer is solely responsible for the content of this announcement.
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.
Mike Sinclair
Halsin Partners
Tel: +44 20 7318 2955
msinclair(at)halsin.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 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.
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Addex Therapeutics via Thomson Reuters ONE
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Datum: 05.06.2012 - 07:00 Uhr
Sprache: Deutsch
News-ID 152935
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