Press Release : Addex Starts Phase 2 Clinical Study of ADX71149 for Epilepsy

 
   First patients enrolled into multi-center U.S. study 
 
   Geneva, Switzerland, June 7, 2021 -- Addex Therapeutics 
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(SIX: ADXN and Nasdaq: ADXN), a clinical-stage pharmaceutical company 
pioneering allosteric modulation-based drug discovery and development, 
today announced that the first patients have been enrolled into a Phase 
2 clinical study evaluating JNJ-40411813 (ADX71149) in patients with 
epilepsy. JNJ-40411813 (ADX71149) is a selective metabotropic glutamate 
type 2 (mGlu2) receptor positive allosteric modulator (PAM). The trial 
is being conducted in collaboration with Janssen Pharmaceuticals, Inc., 
part of the Janssen Pharmaceutical Companies of Johnson & Johnson. 
 
   "Addex is anticipating multiple clinical study catalysts during 2021. 
The first, starting with this epilepsy study, illustrates the continued 
commitment of our long-time collaboration partner Janssen 
Pharmaceuticals, Inc. to this program and to pioneering novel ways to 
help epilepsy patients. Data from the study are expected in Q3 2022," 
said Tim Dyer, CEO of Addex. "The start of additional clinical trials, 
including our pivotal study for our lead program dipraglurant in 
Parkinson's disease patients suffering from dyskinesia remains on track 
for this quarter." 
 
   The multi-center study (ClinicalTrials.gov Identifier: NCT04836559 
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) 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. 
 
   About the Collaboration 
 
   Under 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 EUR109 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. 
 
   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., 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 Addex Therapeutics 
 
   Addex Therapeutics 
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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 product 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 Q2 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 Q2 
2021. Addex's GABA(B) PAM program has been licensed to Indivior PLC, 
which is focused on development 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 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. 
 
   Contacts: 
 
 
 
 
Tim Dyer                   Mike Sinclair              James Carbonara 
 Chief Executive Officer    Partner, Halsin Partners   Hayden IR 
 Telephone: [phone]   [phone]            (646)-755-7412 
 55                         [e-mail]       [e-mail] 
 [e-mail] 
 
   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 and progress 
of clinical trials and preclinical studies, and its future financing 
activities. 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, except as required by law. 
 
 
 
 
 
 

(END) Dow Jones Newswires

June 07, 2021 01:00 ET (05:00 GMT)