Press Release: Addex Receives Additional $2.8 million from Indivior and Extends GABAB PAM Research Collaboration
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Geneva, Switzerland, November 2, 2020 - Addex Therapeutics Ltd (SIX and
Nasdaq: ADXN), a leading company pioneering allosteric modulation-based
drug discovery and development, today announced that the research term
of the agreement signed with Indivior PLC (LON: INDV) in January 2018
has been extended until June 30, 2021. The collaboration with Indivior
covers the discovery of novel oral gamma-aminobutyric acid receptor
subtype B (GABA(B) ) positive allosteric modulator (PAM) compounds as
potential therapies for multiple disease areas. As part of the amended
agreement, Indivior has agreed to pay Addex $2.8 million in research
funding and expand the therapeutic areas where Addex has exclusivity to
develop retained compounds.
"The extension of our research collaboration and the additional funding
from Indivior is a clear recognition of the potential of our allosteric
modulator discovery platform and the significant achievements of our
drug discovery team," said Tim Dyer, CEO of Addex. "Indivior is a world
leader in the development of addiction medication and strongly committed
to GABA(B) PAM as a potential treatment for addiction including alcohol
use disorder."
"Although 200 health conditions have been linked to harmful alcohol use,
(1) there are few pharmacotherapies for alcohol use disorder (AUD) --
their ef cacy and uptake in clinical practice are limited, and patient
acceptance is minimal. We are, therefore, very pleased to expand our
partnership with Addex Therapeutics to discover and profile new potent
and selective GABA(B) PAMs and provide a new class of medications that
has the potential to achieve therapeutic benefits in patients suffering
from AUD," said Christian Heidbreder, Chief Scientific Officer of
Indivior.
"Due to the extensive validation of GABA(B) activation with baclofen,
we believe a novel, orally available GABA(B) PAM could provide
significant benefits to patients in many therapeutics areas," said
Jean-Philippe Rocher, Co-Head of Discovery. "We have advanced multiple
novel chemical series' to late stages of lead optimization and we look
forward to rapidly delivering first-in-class compounds for Indivior to
advance into clinical development."
Under the terms of the original agreement signed with
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Indivior in January 2018, Addex received a $5 million upfront payment
and has since received $5.6 million research funding. Addex is eligible
to receive up to $330 million of development, regulatory and
commercialization milestones as well as tiered royalties up to teen
double-digit. In addition, Addex has the right to retain certain
compounds and pursue their development for reserved indications outside
addiction, including for the treatment of Charcot-Marie-Tooth type 1a
(CMT1A) neuropathy, a rare inherited disorder that affects peripheral
nerves. Addex has discovered novel GABA(B) PAMs and has made
significant progress in optimization of potential drug candidates. Addex
expects to enter clinical candidate selection phase by end of 2020 and
deliver drug candidates for IND enabling studies by the end of 2021 for
both Indivior and for its in-house CMT1A program.
About GABA(B) Activation with PAM
Activation of the GABA(B) receptor, a Family C class of GPCR, is
clinically and commercially validated by the generic GABA(B) receptor
agonist, baclofen which is marketed for spasticity and some spinal cord
injuries. In addition, baclofen is used off label for a number of
disease areas including AUD and overactive bladder, however, its use is
limited due to a variety of side effects and rapid clearance of the
drug. Unlike GABA(B) orthosteric agonists such as baclofen, GABA(B) PAM
only act when the natural ligand (GABA) activates the receptor, and
therefore respect the physiological cycle of activation. Consequently,
its been demonstrated that PAMs are less prone to tolerance and
therefore could produce less adverse effects than direct agonists (May
and Christopoulos 2003; Langmead and Christopoulos 2006; Perdona et al.
2011; Urwyler 2011; Gjoni et al., 2008; Ahnaou et al., 2015).
About Addex Therapeutics
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Addex Therapeutics is a clinical-stage pharmaceutical company focused on
the development and commercialization of an emerging class of novel
orally available small molecule drugs known as allosteric modulators for
neurological disorders. Allosteric modulators offer several potential
advantages over conventional non-allosteric molecules and may offer an
improved therapeutic approach to conventional "orthosteric" small
molecule or biological drugs. Addex's allosteric modulator drug
discovery platform targets receptors and other proteins that are
recognized as essential for therapeutic intervention. Addex's lead drug
candidate, dipraglurant (mGlu5 negative allosteric modulator or NAM), is
scheduled to enter a pivotal registration clinical trial for Parkinson's
disease levodopa induced dyskinesia (PD-LID). In parallel,
dipraglurant's therapeutic use in dystonia is being investigated in
preclinical models. Addex's second clinical program ADX71149 (mGlu2
positive allosteric modulator or PAM), developed in collaboration with
Janssen Pharmaceuticals, Inc., is scheduled to enter a Phase 2a proof of
concept clinical study for the treatment of epilepsy. Preclinical
programs include GABA(B) PAM for CMT1A, mGlu7 NAM for PTSD, mGlu2 NAM
for mild neurocognitive disorders, mGlu4 PAM for Parkinson's disease and
mGlu3 PAM for neurodegenerative disorders.
Press Contacts:
Tim Dyer Mike Sinclair
Chief Executive Officer Partner, Halsin Partners
Telephone: +41 22 884 15 55 +44 (0)20 7318 2955
Email: mailto:PR@addextherapeutics.com PR@addextherapeutics.com mailto:msinclair@halsin.com msinclair@halsin.com
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Forward Looking Statements
Certain statements made in this announcement are forward-looking
statements including with respect to the timing of candidate selection
and delivery of drug candidates under the Indivior agreement and for its
in-house CMT1A program. These forward-looking statements are not
historical facts but rather are based on the Company's current
expectations, estimates, and projections about its industry; its
beliefs; and assumptions. Words such as 'anticipates,' 'expects,'
'intends,' 'plans,' 'believes,' 'seeks,' 'estimates,' and similar
expressions are intended to identify forward-looking statements. These
statements are not guarantees of future performance and are subject to
known and unknown risks, uncertainties, and other factors, some of which
are beyond the Company's control, are difficult to predict, and could
cause actual results to differ materially from those expressed or
forecasted in the forward-looking statements, including clinical and
regulatory developments and the impact of the COVID-19 pandemic. The
Company cautions securityholders and prospective securityholders not to
place undue reliance on these forward-looking statements, which reflect
the view of the Company only as of the date of this announcement. The
forward-looking statements made in this announcement relate only to
events as of the date on which the statements are made. The Company will
not undertake any obligation to release publicly any revisions or
updates to these forward-looking statements to reflect events,
circumstances, or unanticipated events occurring after the date of this
announcement except as required by law or by any appropriate regulatory
authority.
(1) Global status report on alcohol and health 2018. Geneva: World
Health Organization; 2018. Licence: CC BY-NC-SA 3.0 IGO
(END) Dow Jones Newswires
November 02, 2020 01:00 ET (06:00 GMT)
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