Addex Receives Additional $2.8 million from Indivior and Extends GABAB PAM Research Collaboration
November 02 2020 - 1:00AM
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 (GABAB) 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 GABAB 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 efficacy 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 GABAB
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
GABAB activation with baclofen, we believe a novel, orally
available GABAB 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 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 GABAB 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 GABAB Activation with PAM
Activation of the GABAB receptor, a Family C
class of GPCR, is clinically and commercially validated by the
generic GABAB 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 GABAB
orthosteric agonists such as baclofen, GABAB 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
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 GABAB 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 DyerChief Executive OfficerTelephone: +41 22 884 15
55Email: PR@addextherapeutics.com |
Mike SinclairPartner, Halsin Partners+44 (0)20 7318
2955msinclair@halsin.com |
Forward Looking
StatementsCertain 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
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