Addex mGlu2 PAM Program to Advance into Epilepsy Phase 2a Proof of Concept Clinical Study
June 16 2020 - 1:00AM
Study with JNJ-40411813
(ADX71149) will treat first epilepsy patients in early
2021
Geneva, Switzerland, June 16,
2020 – Addex Therapeutics (SIX: ADXN and Nasdaq: ADXN), a
clinical-stage pharmaceutical company pioneering allosteric
modulation-based drug discovery and development, today announced
that the selective metabotropic glutamate type 2 (mGlu2)
receptor positive allosteric modulator (PAM), JNJ-40411813
(ADX71149), will advance into a Phase 2a proof of concept study in
patients with epilepsy. The multi-center study is scheduled to
begin dosing patients in the United States early 2021. Janssen
Pharmaceuticals, Inc., part of the Janssen Pharmaceutical Companies
of Johnson & Johnson, is responsible for the clinical
development and commercialization of JNJ-40411813 (ADX71149) under
the terms of a licensing agreement with Addex.
Glutamate is the primary excitatory
neurotransmitter in the brain and plays a key role in the
initiation and spread of seizures. When activated, the mGlu2
receptor decreases the release of glutamate and consequently helps
to maintain neurotransmitter balance. In the presence of
agonist-induced activation, positive allosteric modulation of mGlu2
receptors could result in the normalization of the excessive
glutamate release seen during a seizure.
“The decision of Janssen to advance ADX71149
into a Phase 2 clinical study is an exciting development and an
important achievement for us,” said Tim Dyer, CEO of Addex. “Addex
now has two active clinical programs with a number of significant
value creating milestones ahead, two major collaborations with
pharma and a pipeline of earlier-stage programs that are moving
rapidly towards the clinic.”
The multi-center study will assess the efficacy,
safety, tolerability and pharmacokinetics of adjunctive
JNJ-40411813 (ADX71149) administration in patients with focal onset
seizures with suboptimal response to levetiracetam. The primary
objective of the study is to evaluate the efficacy of JNJ-40411813
(ADX71149) using a time-to-event endpoint.
“Preclinical studies in epilepsy models have
demonstrated a strong synergistic anti-epileptic effect of ADX71149
and levetiracetam when given in combination,” said Robert Lütjens,
Head of Discovery Biology of Addex. “We are now looking forward to
testing this hypothesis in the clinic, as this represents a
completely novel approach based on a rational polypharmacy
concept.”
About the AgreementUnder the
research collaboration and license agreement, Addex granted Janssen
an exclusive worldwide license to develop and commercialize mGlu2
PAM compounds. Addex is eligible for up to a total of €109 million
in success-based development and regulatory milestone payments. In
addition, Addex is eligible for low double-digit royalties on net
sales of compounds developed under the agreement.
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) is being developed in collaboration
with Janssen Pharmaceuticals, Inc for the treatment of epilepsy. In
addition, Addex’s GABAB PAM program has been licensed to
Indivior PLC for the treatment of addiction. 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 |
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forward-looking statements made in this announcement relate only to
events as of the date on which the statements are made. The Company
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