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: +41 22 884 15 +44 7968 022075 (646)-755-7412

55 msinclair@halsin.com james@haydenir.com

PR@addextherapeutics.com

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)