Addex Strategic Partner Successfully Completes Phase 1 in Japan with ADX71149
15 November 2021 - 5:00PM
Addex Strategic Partner Successfully Completes Phase 1 in Japan
with ADX71149
Setting Up Global
Expansion of Phase 2 Clinical Evaluation in
Epilepsy Patients
Ad Hoc Announcement Pursuant to Art. 53 LR
Geneva, Switzerland,
November 15,
2021 – Addex Therapeutics (SIX:
ADXN and Nasdaq: ADXN), a clinical-stage pharmaceutical company
pioneering allosteric modulation-based drug discovery and
development, today announced that Janssen Pharmaceuticals, Inc.,
part of the Janssen Pharmaceutical Companies of Johnson &
Johnson, has successfully completed Phase 1 studies in Japan with
JNJ-40411813 (ADX71149). ADX71149 is a selective metabotropic
glutamate type 2 (mGlu2) receptor positive allosteric
modulator (PAM). The successful completion of this Phase 1 safety
program will enable centers in Japan to be included in a potential
global development of ADX71149 for the treatment of epilepsy.
“ADX71149 is currently in a transatlantic Phase
2 epilepsy study. The successful completion of safety studies is
important so that Japan can be included in a potential global
development program of ADX71149 for the treatment of epilepsy,”
said Tim Dyer CEO of Addex. “The ongoing study of ADX71149 in
epilepsy patients is on track to deliver interim results in Q3
2022, which will guide future development. Furthermore, our lead
program, dipraglurant, is on track to report data from its Phase 2
blepharospasm study in Q1 2022 as well as data from a pivotal Phase
2b/3 Parkinson’s disease dyskinesia study in Q4 2022.”
The previously announced multi-center Phase 2
study will assess the efficacy, safety, tolerability and
pharmacokinetics of adjunctive 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 ADX71149 in combination with levetiracetam using a
time-to-event endpoint.
Glutamate mGlu2 Receptors and
EpilepsyGlutamate 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. There is still an urgent
need for more effective treatments for epilepsy, with improved
tolerability and safety. JNJ-40411813 (ADX71149) was described in
the Eilat 15 conference summary review as a promising novel
approach currently in development (Bialer et al., 2020. Epilepsia).
Proof of concept data with JNJ-40411813 (ADX71149) and other mGlu2
PAMs in animal models of epilepsy have been published in
peer-reviewed journals (Metcalf et al., 2017 and 2018.
Epilepsia).
About the
CollaborationUnder the research collaboration and
license agreement, Addex granted Janssen Pharmaceuticals, Inc. 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 in a pivotal registration
clinical trial for Parkinson’s disease levodopa induced dyskinesia
(PD-LID) and has entered a Phase 2 clinical study for the treatment
of blepharospasm, a form of dystonia. Addex's third clinical
program, ADX71149 (mGlu2 positive allosteric modulator or PAM),
developed in collaboration with Janssen Pharmaceuticals, Inc., is
in a Phase 2a proof of concept clinical trial for the treatment of
epilepsy. Indivior PLC has licensed Addex’s GABAB PAM program
for the development of drug candidates with a focus in 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. Addex shares are listed on the SIX Swiss Exchange and
American Depositary Shares representing its shares are listed on
the NASDAQ Capital Market, and trade under the ticker symbol "ADXN"
on each exchange.
Contact:
Tim DyerChief
Executive OfficerTelephone: +41 22 884 15
55 PR@addextherapeutics.com |
Mike
SinclairPartner, Halsin Partners+44 (0)20 7318
2955msinclair@halsin.com |
James
CarbonaraHayden IR(646)-755-7412james@haydenir.com |
Addex Forward Looking Statements:
This press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995, as amended, including in respect of the
anticipated initiation of clinical trials. The words “may,” “will,”
“could,” “would,” “should,” “expect,” “plan,” “anticipate,”
“intend,” “believe,” “estimate,” “predict,” “project,” “potential,”
“continue,” “target” and similar expressions are intended to
identify forward-looking statements, although not all
forward-looking statements contain these identifying words. Any
forward-looking statements in this press release, are based on
management's current expectations and beliefs and are subject to a
number of risks, uncertainties and important factors that may cause
actual events or results to differ materially from those expressed
or implied by any forward-looking statements contained in this
press release, including, without limitation, uncertainties related
to market conditions. These and other risks and uncertainties are
described in the Company’s Annual Report on Form 20-F filed with
the SEC on March 11, 2021, as well as market conditions and
regulatory review. Any forward-looking statements contained in this
press release represent Addex Therapeutics’ views only as of the
date hereof and should not be relied upon as representing its views
as of any subsequent date. Addex Therapeutics explicitly disclaims
any obligation to update any forward-looking statements.
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