Addex Partner Starting Clinical Schizophrenia Trial
(Thomson Reuters ONE) -
Addex Pharmaceuticals /
Addex Partner Starting Clinical Schizophrenia Trial
. Processed and transmitted by Thomson Reuters ONE.
The issuer is solely responsible for the content of this announcement.
Geneva, Switzerland, March 28, 2011 - Allosteric modulation company Addex
Pharmaceuticals (SIX:ADXN) announced today the start of a Phase IIa clinical
trial of ADX71149 for the treatment of schizophrenia. ADX71149, a positive
allosteric modulator (PAM) of metabotropic glutamate receptor 2 (mGluR2), is the
result of a successful discovery collaboration and licensing deal announced in
early 2005 between Addex and Ortho-McNeil-Janssen Pharmaceuticals, Inc. (OMJPI).
Addex will receive a ?2 million milestone payment from OMJPI.
"We believe that this mGluR2 PAM potentially offers one of the most exciting new
and innovative ways to treat schizophrenia, anxiety and related indications,"
said Dr Vincent Mutel, CEO of Addex. "Our partner has expertise and an interest
in this indication that are of great value to Addex. This collaboration - which
already is profitable for our young company - illustrates the great potential of
our strategy to capitalize on our allosteric modulator discovery platform via
carefully selected development partnerships like this one."
The double-blind, placebo-controlled EU Phase IIa study will include about 105
schizophrenia patients in two parts:
Part A (monotherapy): 15 subjects with (sub)acute positive symptoms will be
treated in an open-label design with a recommended starting dose of 50 mg bid.
Then according to tolerability, as judged by the investigator, the dose may be
increased stepwise to 100 mg bid up to the recommended target dose of 150 mg
bid. In principle, the open-label treatment phase will last for maximally 12
weeks. Endpoints will examine tolerability, safety and efficacy.
Part B (add-on therapy): In 90 subjects with residual positive symptoms or
predominant negative symptoms or in subjects with insufficient response to
clozapine, ADX71149 will be administered in a double-blind, placebo-controlled,
2:1 (active drug : placebo) randomized design at 2 different dose levels, 50 mg
bid up to maximally 150 mg bid, and this as adjunctive therapy to their
currently prescribed antipsychotic. Endpoints will examine tolerability, safety
and efficacy.
The development of ADX71149 is part of a worldwide research collaboration and
license agreement between Addex and OMJPI to discover, develop and commercialize
novel mGluR2 PAM for the treatment of anxiety, schizophrenia and undisclosed
indications. Under the terms of the agreement, Addex is eligible for up to a
total of ?112 million in milestone payments upon potential development and
regulatory achievements. In addition, Addex is eligible for low double-digit
royalties on sales of mGluR2 PAM developed under the agreement.
Glutamate is a powerful transmitter in the brain and integral to the normal
functioning of memory, learning and perception. Too much glutamate can lead to
seizures and the death of brain cells. Too little glutamate can cause psychosis,
coma and death. Glutamate exerts these effects by interacting with many
receptors in the brain, especially NMDA and AMPA receptors. In addition to these
primary receptors, glutamate triggers other receptors, termed metabotropic
because they adjust the amount of glutamate that cells release rather than
simply turning glutamate transmission on or off. In addition, there are eight
types of mGluR, each with different functions. Thus, these metabotropic
glutamate receptors (mGluR), because of their ability to fine-tune glutamate
signaling, appear to be better targets for drug treatment. Indeed, industry has
been investing in mGluR research for about three decades and research shows that
mGluR drugs have potential for the treatment of schizophrenia, anxiety,
Parkinson's disease, fragile X syndrome, Alzheimer's disease, depression and
post-traumatic stress disorder.
The effects of positive allosteric modulators of mGluR2 are independent of
dopamine receptors, indicating the potential for mGluR modulators to offer
efficacy while avoiding the side effects associated with market leading anti-
psychotic drugs which appear to work predominantly via their effects on dopamine
receptors.
Furthermore, mGluR2 activation has shown efficacy in patients suffering from
schizophrenia and, separately, anxiety. A Phase II clinical study published in
Nature Medicine* showed that activation of mGluR2 improved symptoms of
schizophrenia with efficacy similar to that of one of the leading marketed drugs
but did not cause weight gain or extrapyramidal symptoms, which are side effects
that can be associated with the use of the leading marketed drugs. Another study
showed that mGluR2 activation had a statistically significant benefit in
patients suffering from generalized anxiety disorder**.
*Nature Medicine 13, 1102 - 1107 (2007)
**Neuropsychopharmacology 33, 1603-1610 (2008)
Addex Pharmaceuticals (www.addexpharma.com) discovers and develops allosteric
modulators for human health. The company is focused on using its proprietary
discovery platform to discover allosteric modulators of cell surface receptors
that are believed to have therapeutic potential for treating diseases of the
central nervous system, metabolic disorders or inflammation. Subject to
regulatory approvals, several Phase II clinical trials are expected to start
soon for two lead products: ADX48621 and ADX71149. ADX71149 is undergoing Phase
II testing for schizophrenia and may enter additional Phase II studies in
anxiety and/or undisclosed indications. ADX48621 is an mGluR5 negative
allosteric modulator (NAM), which will be tested in Parkinson's disease
levodopa-induced dyskinesia (PD-LID) and, separately, non-Parkinsonian patients
suffering from dystonia, also a movement disorder. Other products nearing the
clinic include: GABA-B receptor PAM with potential for chronic pain; follicle
stimulating hormone receptor (FSHR) NAM, with potential for endometriosis and
benign prostatic hyperplasia; and, mGluR2 NAM for Alzheimer's disease. In
addition, Merck & Co., Inc. has licensed rights to two preclinical programs:
mGluR4 PAM for Parkinson's disease and mGluR5 PAM for schizophrenia. Preclinical
discovery stage programs include: GLP1R PAM; IL1R1 NAM; and TNFR1 NAM.
Chris Maggos
Business Development & Communication
Addex Pharmaceuticals
+41 22 884 15 11
chris.maggos(at)addexpharma.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
Pharmaceuticals Ltd, 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
Pharmaceuticals Ltd 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 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 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 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
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 Pharmaceuticals Ltd 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.
--- End of Message ---
Addex Pharmaceuticals
12, chemin des Aulx Plan-les-Ouates; Geneva Switzerland
ISIN: CH0029850754;
English pdf:
http://hugin.info/138017/R/1500628/435981.pdf
Deutsch pdf:
http://hugin.info/138017/R/1500628/435982.pdf
Français pdf:
http://hugin.info/138017/R/1500628/435983.pdf
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 Pharmaceuticals via Thomson Reuters ONE
[HUG#1500628]
Unternehmensinformation / Kurzprofil:
Datum: 28.03.2011 - 07:01 Uhr
Sprache: Deutsch
News-ID 52838
Anzahl Zeichen: 11332
contact information:
Town:
Plan-les-Ouates, Geneva
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 261 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Addex Partner Starting Clinical Schizophrenia Trial"
steht unter der journalistisch-redaktionellen Verantwortung von
Addex Pharmaceuticals (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
