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 Agreement
Under 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.
Chief Executive Officer
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