Addex Licensee Completes Enrolment of 120 Patients in a Phase 2 Clinical Trial of ADX71149 for the Treatment of Anxious Depression
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Addex Therapeutics /
Addex Licensee Completes Enrolment of 120 Patients in a Phase 2 Clinical Trial
of ADX71149 for the Treatment of Anxious Depression
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On track to report top line results end of Q1 2014
Geneva, Switzerland, 29 October 2013 - 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 completed enrollment of 120 patients in a
multicenter, double-blind, Phase 2 study of ADX71149 in adults with major
depressive disorder who are also suffering anxiety symptoms.
"The completion of enrolment in this second Phase 2 study is an important
achievement and demonstrates both the significant potential of ADX71149 and the
commitment of Janssen to advance ADX71149 to this stage of development," noted
Tim Dyer, CEO at Addex. "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) is being conducted as an adjunctive treatment to an antidepressant
in 120 adults with major depressive disorder with anxiety symptoms and partial
response to SSRI/SNRI (HDRS ³ 18 and Anx/Som Factor ³ 7). Oral ADX71149 is being
administered twice-daily at doses ranging from 25mg to 150mg. Patients continue
to take the same daily dose of their antidepressant. The primary endpoint of the
study is the change from baseline in the 6-item subscale of 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.
About mGlu2 Activation and ADX71149
ADX71149 is a novel, first-in-class potent, oral, small molecule positive
allosteric modulator (PAM) of metabotropic glutamate receptor 2 (mGlu2), a
Family C class of G Protein Coupled Receptor (GPCR). 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. In a phase 2 clinical trial of ADX71149 in
schizophrenia patients, ADX71149 demonstrated positive effects in schizophrenia
patients suffering from residual negative symptoms.
About Anxious Depression
Unipolar depression is the leading cause of disability worldwide (2008 WHO
Global Burden of Disease Report) and anxiety symptoms are commonly reported in
major depressive disorder (MDD) patients. 85% of adults with MDD exhibit
significant anxiety symptoms (Gorman, 1996); and approximately 50% of
outpatients with MDD have a comorbid anxiety disorder, 58% lifetime (Fava et
al., 2000; Kessler et al., 1996). Comorbid anxiety results in more severe
depressive symptoms, increased suicide risk, more chronic course, poorer and
slower treatment response, greater functional and occupational impairment,
increased societal burden/socioeconomic costs, and increased health care
utilization. The first line treatments for MDD patients with comorbid anxiety
are SSRIs and SNRIs, however, this subpopulation is less responsive and
continues to demonstrate a great unmet need. Adjunctive treatments to
SSRIs/SNRIs for anxious depression result in significant added side effect
burden and are often poorly tolerated in long term treatment. The STAR*D
clinical study, the largest effectiveness study evaluating next-step therapies
in real-world patients with major depressive disorder, showed that patients with
anxious depression were less likely to achieve remission or respond to treatment
than those with non-anxious depression (Fava et al. 2008).
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 (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 also has several
preclinical programs including: GABAB receptor 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 Executive Officer
Addex Therapeutics
+41 22 884 1561
PR(at)addextherapeutics.com
Disclaimer: The foregoing release may contain forward-looking statements that
can be identified by terminology such as "seek", "not pursue", "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, 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 factors 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 Addex Therapeutics will complete the restructuring and reduction of its
liabilities or any financing nor 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.
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
[HUG#1738553]
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Datum: 29.10.2013 - 07:00 Uhr
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News-ID 310072
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