Addex Receives Approval to Initiate a Phase 1, First-In-Man, Clinical Study for ADX71441
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Addex Therapeutics /
Addex Receives Approval to Initiate a Phase 1, First-In-Man, Clinical Study for
ADX71441
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ADX71441, a novel oral small molecule GABA-B receptor positive allosteric
modulator, on track to initiate clinical testing in first half of 2013 and to
deliver top-line safety, PK and biomarker data by year end
Geneva, Switzerland, 24 April 2013 - Addex Therapeutics (SIX: ADXN), a leading
company pioneering allosteric modulation-based drug discovery and development
announced today that the regulatory authorities in the Netherlands have approved
the clinical trial application (CTA) to initiate a Phase 1 study of ADX71441, a
GABA-B receptor positive allosteric modulator (PAM). The Company plans to
initiate clinical testing at the Centre of Human Drug Research in Leiden, in the
first half of 2013 and expects to deliver top-line safety, pharmacokinetic and
biomarker data by year end. Addex previously announced achievement of positive
Proof of Concept for ADX71441 in a validated pre-clinical model of Charcot-
Marie-Tooth 1A (CMT1A) neuropathy as well as a number of other disease
indications. The Company plans to move quickly to Phase 2a testing of ADX71441
for the treatment of CMT1A, an orphan disease, in 2014. The CTA was submitted
to the authorities in March 2013.
"We are delighted to receive this approval for ADX71441 and to be able to
initiate clinical development of this exciting molecule," said Sonia Poli,
Ph.D., Vice President, Translational Sciences and Project Leader for the
ADX71441 program at Addex. "We believe the speed at which the Dutch authorities
approved the CTA attests to the quality of our preclinical data and related
material. We plan to seek orphan drug designation for this compound in the
treatment of CMT1A and attempt to take advantage of a rapid development and
regulatory path to market."
ADX71441 is a potent, selective, orally available small molecule that is brain
penetrant and shows good pharmacokinetic properties for once-daily dosing.
Activation of gamma-aminobutyric acid subtype B (GABA-B) receptor, a Family C
class of GPCR, is clinically and commercially validated in several indications
including spasticity, overactive bladder (OAB), spinal cord injuries and
gastroesophageal reflux disease. However, generic GABA-B receptor agonists are
not commonly used in certain disorders due to compliance-limiting drug side
effects, receptor sensitization, rebound effect and rapid clearance. An oral
once-daily small molecule activator of GABA-B receptor without the issues
associated with the current GABA-BR agonists could dramatically change the
treatment paradigm for a number of diseases. Allosteric modulation is ideally
suited to overcome such limitations of an agonist. ADX71441 has shown efficacy
in multiple preclinical models including: CMT1A, OAB, pain, obsessive-compulsive
disorder, alcohol binge drinking and anxiety. The United States Patent and
Trademark Office recently granted Addex a composition of matter patent covering
ADX71441 and other GABA-B receptor PAMs. The claims of the issued patent also
cover pharmaceutical composition and method of treatment using such GABA-BR
PAMs.
"This is an important accomplishment for the company as we continue to execute
on our strategy to focus on the clinical development of novel compounds to treat
orphan diseases," said Graham Dixon, Ph.D., Chief Scientific Officer at Addex.
"With this CTA approval, our pipeline consists of four Phase 2 programs, one
Phase 1 program and one preclinical program which we hope to advance to Phase 1
testing by the end of next year. This robust pipeline represents multiple,
strong value drivers which we believe have the potential to generate significant
shareholder value."
About Charcot-Marie-Tooth 1A (CMT1A)
CMT1A is a rare (1:5,000) hereditary motor and sensory demyelinating peripheral
neuropathy (also known as Hereditary Motor and Sensory Neuropathy, HMSN) which
is caused by an intrachromosomal duplication and consecutive toxic
overexpression of the PMP22 gene on chromosome 17. CMT1A is one of the most
common inherited peripheral nerve-related disorders, which is passed down
through families in an autosomal dominant fashion. CMT1A disease becomes evident
in young adulthood and slowly progresses with distally pronounced muscle
weakness and numbness. Pain can range from mild to severe. The disease can be
highly debilitating, including being wheelchair bound, and is often accompanied
by severe cases of neurological pain. There is no known cure for this
incapacitating disease. Data obtained with ADX71441 and a GABA-BR agonist seems
to suggest that positive modulation of the GABA-B receptor could lower toxic
PMP22 overexpression and potentially delay the progression of the disease and
offer a unique therapeutic opportunity for CMT1A patients.
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 (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 is also advancing
several preclinical programs including: GABA-BR 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 Financial Officer
Addex Therapeutics
+41 22 884 15 61
PR(at)addextherapeutics.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 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
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
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Datum: 24.04.2013 - 07:00 Uhr
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News-ID 252197
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