Press Release : Addex ADX71149 Receives IND Approval to Start a Phase 2a Clinical Study in Epilepsy

 
   First patient treated with ADX71149 (JNJ-40411813) scheduled for Q2 2021 
 
   Geneva, Switzerland, January 21, 2021 -- 
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Addex Therapeutics (SIX: ADXN and Nasdaq: ADXN), a clinical-stage 
pharmaceutical company pioneering allosteric modulation-based drug 
discovery and development, today announced that its partner Janssen 
Pharmaceuticals, Inc., part of the Janssen Pharmaceutical Companies of 
Johnson & Johnson, has received FDA's Investigational New Drug (IND) 
approval to begin a Phase 2a proof of concept study with the selective 
metabotropic glutamate type 2 (mGlu2) receptor positive allosteric 
modulator (PAM), JNJ-40411813 (ADX71149), in patients with epilepsy. The 
first patient is expected to be treated during Q2 2021. 
 
   "IND approval for the mGlu2 epilepsy study is great news to start 2021 
and will be the first of three clinical studies we expect to be initiate 
this year," said Tim Dyer, CEO of Addex. "There is a great opportunity 
for an allosteric modulation approach in this difficult disease. We'd 
like to thank the team involved for their continued support and moving 
quickly to get this clinical study ready for patient enrolment." 
 
   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) in combination with 
levetiracetam using a time-to-event endpoint. 
 
   "There is a strong preclinical rationale for mGlu2 PAM in epilepsy, 
including a true synergistic effect with levetiracetam," said Robert 
Lütjens, Head of Discovery Biology of Addex. "A highly synergistic 
anti-epileptic effect was observed when the two drugs were administered 
together, and we look forward to seeing this effect in epilepsy 
patients." 
 
   Glutamate, mGlu2 Receptors and Epilepsy 
 
   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. 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 one of the most promising novel approaches currently 
in development (Bialer et al., 2019. 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 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 
poised to start a pivotal registration clinical trial for Parkinson's 
disease levodopa induced dyskinesia (PD-LID) in H1 2021. Addex is also 
investigating dipraglurant's therapeutic use in blepharospasm (a type of 
dystonia), for which a clinical trial is expected to be initiated in H1 
2021. Addex's third 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 in Q2 2021. Addex's GABAB 
PAM program has been licensed to Indivior PLC for the treatment of 
addiction. 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. Addex 
is listed on the SIX Swiss Exchange and the NASDAQ Capital Market and 
trades under the ticker symbol "ADXN". 
 
   Press Contacts: 
 
 
 
 
Tim Dyer                                                          Mike Sinclair 
 Chief Executive Officer                                           Partner, Halsin Partners 
 Telephone: [phone]                                       [phone] 
 Email: mailto:[e-mail] [e-mail]   mailto:[e-mail] [e-mail] 
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   Forward Looking Statements 
 
   Certain statements made in this announcement are forward-looking 
statements. 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. 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. 
 
 
 
 

(END) Dow Jones Newswires

January 21, 2021 01:00 ET (06:00 GMT)